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THE AMERICAN COLLEGE OF
 OBSTETRICIANS AND GYNECOLOGISTS
           W OMEN ’ S H EALTH C ARE P HYSICIANS




COMPENDIUM
        of Selected Publications
The Compendium of Selected Publications CD-ROM contains all Committee Opinions,
Practice Bulletins, Policy Statements, and Technology Assessments published by the
American College of Obstetricians and Gynecologists (the College) as of December 31,
2009. The information in these documents should not be viewed as establishing standards
or dictating rigid rules. The guidelines are general and intended to be adapted to many
different situations, taking into account the needs and resources particular to the locality, the
institution, or the type of practice. Variations and innovations that improve the quality of
patient care are to be encouraged rather than restricted. The purpose of these guidelines will
be well served if they provide a firm basis on which local norms may be built.

Copyright 2010 by the American College of Obstetricians and Gynecologists. All rights
reserved. No part of this publication may be reproduced, stored in a retrieval system,
posted on the Internet, or transmitted, in any form or by any means, electronic, mechanical,
photocopying, recording, or otherwise, without prior written permission from the publisher.

The American College of Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920

ISBN: 978-1-934946-88-6

Publications can be ordered through the College Distribution Center by calling toll free
800-762-2264. To receive order forms via facsimile, call (732) 885-6364 and follow the audio
instructions. Publications also can be ordered from the College web site at www.acog.org.




   The following resources from the College also contain College practice
   guidelines and should be considered adjuncts to the documents in the
   Compendium of Selected Publications CD-ROM.

   Guidelines for Perinatal Care, Sixth Edition
   Guidelines for Women’s Health Care, Third Edition
   Health Care for Adolescents
   Special Issues in Women’s Health

   These documents are available online to members at www.acog.org
SEARCH
Contents
F OREWORD                                                                                                  xi
T HE S COPE     OF   P RACTICE   OF   O BSTETRICS   AND   G YNECOLOGY                                     xii
C ODE   OF    P ROFESSIONAL E THICS                                                                       xiii

C OMMITTEE O PINIONS
C OMMITTEE      ON    A DOLESCENT H EALTH C ARE
        302    Guidelines for Adolescent Health Research                                                    3
        310    Endometriosis in Adolescents                                                                 7
        314    Meningococcal Vaccination for Adolescents                                                   14
        344    Human Papillomavirus Vaccination
                  (Joint with the ACOG Working Group on Immunization)                                      17
        349    Menstruation in Girls and Adolescents: Using the Menstrual Cycle as a Vital Sign
                  (Joint with the American Academy of Pediatrics)                                          24
        350    Breast Concerns in the Adolescent                                                           30
        351    The Overweight Adolescent: Prevention, Treatment, and Obstetric–Gynecologic Implications    38
        355    Vaginal Agenesis: Diagnosis, Management, and Routine Care                                   50
        392    Intrauterine Device and Adolescents                                                         55
        415    Depot Medroxyprogesterone Acetate and Bone Effects
                  (Joint with Committee on Gynecologic Practice)                                           58
        417    Addressing Health Risks of Noncoital Sexual Activities
                  (Joint with Committee on Gynecologic Practice)                                           62
    *448       Menstrual Manipulation for Adolescents with Disabilities                                    65
    *451       Von Willebrand Disease in Women
                  (Joint with Committee on Gynecologic Practice)                                           69

C OMMITTEE      ON   C ODING     AND   N OMENCLATURE
        205    Tubal Ligation with Cesarean Delivery                                                       77
        249    Coding Responsibility                                                                       78
        250    Inappropriate Reimbursement Practices by Third-Party Payers                                 79

C OMMITTEE      ON E THICS
        297    Nonmedical Use of Obstetric Ultrasonography                                                 85
        321    Maternal Decision Making, Ethics, and the Law                                               87
        341    Ethical Ways for Physicians to Market a Practice                                            98
        347    Using Preimplantation Embryos for Research                                                 102
        352    Innovative Practice: Ethical Guidelines                                                    115
        358    Professional Responsibilities in Obstetric–Gynecologic Education                           122


*Published in 2009

                                                                                                                 iii
iv            COMPENDIUM OF SELECTED PUBLICATIONS




C OMMITTEE     ON E THICS (continued)
       359    Commercial Enterprises in Medical Practice                                                    126
       360    Sex Selection                                                                                 129
       362    Medical Futility                                                                              133
       363    Patient Testing: Ethical Issues in Selection and Counseling                                   137
       364    Patents, Medicine, and the Interests of Patients (Joint with Committee on Genetics)           140
       365    Seeking and Giving Consultation                                                               145
       368    Adoption                                                                                      150
       369    Multifetal Pregnancy Reduction                                                                154
       370    Institutional Responsibility to Provide Legal Representation                                  159
       371    Sterilization of Women, Including Those With Mental Disabilities                              161
       373    Sexual Misconduct                                                                             165
       374    Expert Testimony                                                                              169
       377    Research Involving Women                                                                      171
       385    The Limits of Conscientious Refusal in Reproductive Medicine                                  177
       389    Human Immunodeficiency Virus                                                                  183
       390    Ethical Decision Making in Obstetrics and Gynecology                                          189
       395    Surgery and Patient Choice                                                                    198
       397    Surrogate Motherhood                                                                          203
       401    Relationships With Industry                                                                   209
       403    End-of-Life Decision Making                                                                   215
       409    Direct-to-Consumer Marketing of Genetic Testing (Joint with Committee on Genetics)            222
       410    Ethical Issues in Genetic Testing (Joint with Committee on Genetics)                          224
       422    At-Risk Drinking and Illicit Drug Use: Ethical Issues in Obstetric and Gynecologic Practice   232
      *439    Informed Consent                                                                              244

C OMMITTEE     ON   G ENETICS
        318   Screening for Tay–Sachs Disease                                                               255
        324   Perinatal Risks Associated With Assisted Reproductive Technology
                (Joint with Committees on Obstetric Practice and Gynecologic Practice)                      257
       325    Update on Carrier Screening for Cystic Fibrosis                                               261
       338    Screening for Fragile X Syndrome                                                              265
       393    Newborn Screening                                                                             268
       399    Umbilical Cord Blood Banking (Joint with Committee on Obstetric Practice)                     272
      *430    Preimplantation Genetic Screening for Aneuploidy                                              275
      *432    Spinal Muscular Atrophy                                                                       277
      *442    Preconception and Prenatal Carrier Screening for Genetic Diseases
                in Individuals of Eastern European Jewish Descent                                           280
      *446    Array Comparative Genomic Hybridization in Prenatal Diagnosis                                 284
      *449    Maternal Phenylketonuria                                                                      287
         1    Genetics and Molecular Diagnostic Testing                                                     289




     *Published in 2009
      Technology Assessment
CONTENTS          v




C OMMITTEE   ON   G YNECOLOGIC P RACTICE
     240     Statement on Surgical Assistants (Joint with Committee on Obstetric Practice)                 311
     253     Nongynecologic Procedures                                                                     312
     278     Avoiding Inappropriate Clinical Decisions Based
                on False-Positive Human Chorionic Gonadotropin Test Results                                313
     280     The Role of the Generalist Obstetrician–Gynecologist in the Early
                Detection of Ovarian Cancer (Joint with Society of Gynecologic Oncologists)                316
     313     The Importance of Preconception Care in the Continuum of Women’s Health Care                  319
     319     The Role of the Obstetrician–Gynecologist in the Assessment and Management of Obesity         321
     322     Compounded Bioidentical Hormones                                                              326
     323     Elective Coincidental Appendectomy                                                            328
     332     Hepatitis B and Hepatitis C Virus Infections in Obstetrician–Gynecologists                    330
     334     Role of the Obstetrician–Gynecologist in the Screening and Diagnosis of Breast Masses         332
     336     Tamoxifen and Uterine Cancer                                                                  334
     337     Noncontraceptive Uses of the Levonorgestrel Intrauterine System                               338
     345     Vulvodynia (Joint with American Society for Colposcopy and Cervical Pathology)                342
     372     The Role of Cystourethroscopy in the Generalist Obstetrician–Gynecologist Practice            346
     375     Brand Versus Generic Oral Contraceptives                                                      350
     378     Vaginal “Rejuvenation” and Cosmetic Vaginal Procedures                                        352
     384     Colonoscopy and Colorectal Cancer Screening and Prevention                                    354
     387     Pharmaceutical Compounding                                                                    358
     388     Supracervical Hysterectomy                                                                    360
     396     Intraperitoneal Chemotherapy for Ovarian Cancer                                               363
     405     Ovarian Tissue and Oocyte Cryopreservation                                                    366
     407     Low Bone Mass (Osteopenia) and Fracture Risk                                                  368
     408     Professional Liability and Gynecology-Only Practice
                (Joint with Committees on Obstetric Practice and Professional Liability)                   371
    411      Routine Human Immunodeficiency Virus Screening                                                372
    412      Aromatase Inhibitors in Gynecologic Practice                                                  375
    413      Age-Related Fertility Decline (Joint with American Society for Reproductive Medicine)         378
    420      Hormone Therapy and Heart Disease                                                             381
   *434      Induced Abortion and Breast Cancer Risk                                                       385
   *440      The Role of Transvaginal Ultrasonography in the Evaluation of Postmenopasual Bleeding         387
   *444      Choosing the Route of Hysterectomy for Benign Diseases                                        390
   *450      Increasing Use of Contraceptive Implants and Intrauterine Devices to Reduce
                Unintended Pregnancy (Joint with the Long Acting Reversible Contraception Working Group)   393
   *452      Primary and Preventive Care: Periodic Assessments                                             398
      4      Hysteroscopy                                                                                  406
      5      Sonohysterography                                                                             410
     *6      Robot-Assisted Surgery                                                                        413




  *Published in 2009
   Technology Assessment
vi          COMPENDIUM OF SELECTED PUBLICATIONS




C OMMITTEE   ON      H EALTH C ARE   FOR   U NDERSERVED W OMEN
      307    Partner Consent for Participation in Women’s Reproductive Health Research                  419
      312    Health Care for Homeless Women                                                             422
      316    Smoking Cessation During Pregnancy (Joint with Committee on Obstetric Practice)            428
      317    Racial and Ethnic Disparities in Women’s Health                                            434
      343    Psychosocial Risk Factors: Perinatal Screening and Intervention                            438
      361    Breastfeeding: Maternal and Infant Aspects (Joint with Committee on Obstetric Practice)    447
      391    Health Literacy                                                                            449
      414    Human Immunodeficiency Virus and Acquired Immunodeficiency
               Syndrome and Women of Color                                                              452
      416    The Uninsured                                                                              456
     *423    Motivational Interviewing: A Tool for Behavior Change                                      460
     *424    Abortion Access and Training                                                               464
     *425    Health Care for Undocumented Immigrants                                                    468
     *428    Legal Status: Health Impact for Lesbian Couples                                            472
     *429    Health Disparities for Rural Women                                                         476
     *437    Community Involvement and Volunteerism                                                     480

C OMMITTEE   ON I NTERNATIONAL        A FFAIRS
     *427    Misoprostol for Postabortion Care                                                          485

C OMMITTEE   ON      O BSTETRIC P RACTICE
      125    Placental Pathology                                                                        491
      234    Scheduled Cesarean Delivery and the Prevention of Vertical Transmission of HIV Infection   492
      260    Circumcision                                                                               495
      267    Exercise During Pregnancy and the Postpartum Period                                        497
      268    Management of Asymptomatic Pregnant or Lactating Women Exposed to Anthrax                  500
      275    Obstetric Management of Patients with Spinal Cord Injuries                                 503
      276    Safety of Lovenox in Pregnancy                                                             506
      279    Prevention of Early-Onset Group B Streptococcal Disease in Newborns                        508
      281    Rubella Vaccination                                                                        516
      284    Nonobstetric Surgery in Pregnancy                                                          517
      295    Pain Relief During Labor (Joint with American Society of Anesthesiologists)                518
      299    Guidelines for Diagnostic Imaging During Pregnancy                                         519
      305    Influenza Vaccination and Treatment During Pregnancy                                       524
      315    Obesity in Pregnancy                                                                       526
      326    Inappropriate Use of the Terms Fetal Distress and Birth Asphyxia                           531
      333    The Apgar Score (Joint with American Academy of Pediatrics)                                533
      339    Analgesia and Cesarean Delivery Rates                                                      537
      340    Mode of Term Singleton Breech Delivery                                                     539




*Published in 2009
CONTENTS         vii




C OMMITTEE    ON     O BSTETRIC P RACTICE (continued)
      342    Induction of Labor for Vaginal Birth After Cesarean Delivery                                  542
      346    Amnioinfusion Does Not Prevent Meconium Aspiration Syndrome                                   545
      348    Umbilical Cord Blood Gas and Acid-Base Analysis                                               548
      376    Nalbuphine Hydrochloride Use for Intrapartum Analgesia                                        552
      379    Management of Delivery of a Newborn With Meconium-Stained Amniotic Fluid                      553
      381    Subclinical Hypothyroidism in Pregnancy                                                       554
      382    Fetal Monitoring Prior to Scheduled Cesarean Delivery                                         556
      394    Cesarean Delivery on Maternal Request                                                         557
      402    Antenatal Corticosteroid Therapy for Fetal Maturation                                         561
      404    Late-Preterm Infants                                                                          564
      418    Prenatal and Perinatal Human Immunodeficiency Virus Testing:
               Expanded Recommendations                                                                    568
      419    Use of Progesterone to Reduce Preterm Birth
               (Joint with Society for Maternal Fetal Medicine)                                            572
     421     Antibiotic Prophylaxis for Infective Endocarditis                                             575
    *433     Optimal Goals for Anesthesia Care in Obstetrics
               (Joint with American Society of Anesthesiologists)                                          577
    *435     Postpartum Screening for Abnormal Glucose Tolerance in Women Who Had
               Gestational Diabetes Mellitus                                                               580
    *438     Update on Immunization and Pregnancy: Tetanus, Diphtheria, and Pertussis Vaccination          583
    *441     Oral Intake During Labor                                                                      586
    *443     Air Travel During Pregnancy                                                                   587
    *445     Antibiotics for Preterm Labor (Joint with Society for Maternal Fetal Medicine)                589

C OMMITTEE    ON     P ROFESSIONAL L IABILITY
      380    Disclosure and Discussion of Adverse Events (Joint with Committee on Patient Safety and
               Quality Improvement)                                                                        593
      406    Coping With the Stress of Medical Professional Liability Litigation                           595

C OMMITTEE    ON PATIENT S AFETY AND      Q UALITY I MPROVEMENT
     320     Partnering With Patients to Improve Safety                                                    599
     327     “Do Not Use” Abbreviations                                                                    602
     328     Patient Safety in the Surgical Environment                                                    604
     329     Tracking and Reminder Systems                                                                 609
     331     Safe Use of Medication                                                                        612
     353     Medical Emergency Preparedness                                                                616
     366     Disruptive Behavior                                                                           619
     367     Communication Strategies for Patient Handoffs                                                 621
     398     Fatigue and Patient Safety                                                                    624
     400     Technologic Advances to Reduce Medication-Related Errors                                      627
    *447     Patient Safety in Obstetrics and Gynecology                                                   631




*Published in 2009
viii        COMPENDIUM OF SELECTED PUBLICATIONS




R EADING     THE      M EDICAL L ITERATURE                                                        637


P RACTICE B ULLETINS
C OMMITTEE   ON      P RACTICE B ULLETINS —O BSTETRICS
        4    Prevention of Rh D Alloimmunization                                                  647
        6    Thrombocytopenia in Pregnancy                                                        655
        9    Antepartum Fetal Surveillance                                                        666
       12    Intrauterine Growth Restriction                                                      677
       13    External Cephalic Version                                                            689
       17    Operative Vaginal Delivery                                                           696
       19    Thromboembolism in Pregnancy                                                         704
       20    Perinatal Viral and Parasitic Infections                                             714
       22    Fetal Macrosomia                                                                     727
       24    Management of Recurrent Early Pregnancy Loss                                         738
       29    Chronic Hypertension in Pregnancy                                                    750
       30    Gestational Diabetes                                                                 759
       31    Assessment of Risk Factors for Preterm Birth                                         773
       33    Diagnosis and Management of Preeclampsia and Eclampsia                               781
       36    Obstetric Analgesia and Anesthesia                                                   790
       37    Thyroid Disease in Pregnancy                                                         805
       38    Perinatal Care at the Threshold of Viability                                         815
       40    Shoulder Dystocia                                                                    823
       43    Management of Preterm Labor                                                          829
       44    Neural Tube Defects                                                                  838
       48    Cervical Insufficiency                                                               849
       49    Dystocia and Augmentation of Labor                                                   858
       52    Nausea and Vomiting of Pregnancy                                                     868
       54    Vaginal Birth After Previous Cesarean Delivery                                       881
       55    Management of Postterm Pregnancy                                                     891
       56    Multiple Gestation: Complicated Twin, Triplet, and High-Order Multifetal Pregnancy
                (Joint with Society for Maternal–Fetal Medicine)                                  899
       60    Pregestational Diabetes Mellitus                                                     914
       68    Antiphospholipid Syndrome                                                            925
       71    Episiotomy                                                                           934
       75    Management of Alloimmunization During Pregnancy                                      940
       76    Postpartum Hemorrhage                                                                948
       77    Screening for Fetal Chromosomal Abnormalities
                (Joint with Committee on Genetics and the Society for Maternal–Fetal Medicine)    957
       78    Hemoglobinopathies in Pregnancy                                                      968
       80    Premature Rupture of Membranes                                                       977




*Published in 2009
CONTENTS          ix




C OMMITTEE   ON   P RACTICE B ULLETINS —O BSTETRICS (continued)
     82      Management of Herpes in Pregnancy                                                                990
     86      Viral Hepatitis in Pregnancy                                                                    1000
     88      Invasive Prenatal Testing for Aneuploidy (Joint with Committee on Genetics)                     1015
     90      Asthma in Pregnancy                                                                             1024
     92      Use of Psychiatric Medications During Pregnancy and Lactation                                   1032
     95      Anemia in Pregnancy                                                                             1052
     97      Fetal Lung Maturity                                                                             1059
   *100      Critical Care in Pregnancy                                                                      1069
   *101      Ultrasonography in Pregnancy                                                                    1077
   *102      Management of Stillbirth                                                                        1088
   *105      Bariatric Surgery and Pregnancy                                                                 1102
   *106      Intrapartum Fetal Heart Rate Monitoring: Nomenclature, Interpretation, and General
                Management Principles                                                                        1111
   *107      Induction of Labor                                                                              1122
    251      Obstetric Aspects of Trauma Management                                                          1134

C OMMITTEE   ON   P RACTICE B ULLETINS —G YNECOLOGY
     11      Medical Management of Endometriosis                                                             1143
     14      Management of Anovulatory Bleeding                                                              1156
     15      Premenstrual Syndrome                                                                           1164
     28      Use of Botanicals for Management of Menopausal Symptoms                                         1173
     34      Management of Infertility Caused by Ovulatory Dysfunction                                       1184
     35      Diagnosis and Treatment of Cervical Carcinomas                                                  1196
     39      Selective Estrogen Receptor Modulators                                                          1209
     42      Breast Cancer Screening                                                                         1219
     46      Benefits and Risks of Sterilization                                                             1231
     50      Osteoporosis                                                                                    1243
     51      Chronic Pelvic Pain                                                                             1257
     53      Diagnosis and Treatment of Gestational Trophoblastic Disease
                (Joint with Society of Gynecologic Oncologists)                                              1274
     57      Gynecologic Herpes Simplex Virus Infections                                                     1287
     59      Intrauterine Device                                                                             1294
     61      Human Papillomavirus                                                                            1304
     63      Urinary Incontinence in Women                                                                   1318
     65      Management of Endometrial Cancer
                (Joint with Society of Gynecologic Oncologists)                                              1331
     67      Medical Management of Abortion                                                                  1344
     69      Emergency Contraception                                                                         1356
     72      Vaginitis                                                                                       1367
     73      Use of Hormonal Contraception in Women With Coexisting Medical Conditions                       1379




   *Published in 2009
x           COMPENDIUM OF SELECTED PUBLICATIONS




C OMMITTEE   ON      P RACTICE B ULLETINS —G YNECOLOGY (continued)
      81  Endometrial Ablation                                                                  1399
      83  Management of Adnexal Masses                                                          1415
      84  Prevention of Deep Vein Thrombosis and Pulmonary Embolism                             1429
      85  Pelvic Organ Prolapse                                                                 1441
      89  Elective and Risk-Reducing Salpingo-oophorectomy                                      1454
      91  Treatment of Urinary Tract Infections in Nonpregnant Women                            1465
      93  Diagnosis and Management of Vulvar Skin Disorders                                     1475
      94  Medical Management of Ectopic Pregnancy                                               1486
      96  Alternatives to Hysterectomy in the Management of Leiomyomas                          1493
      99  Management of Abnormal Cervical Cytology and Histology                                1507
     *103 Hereditary Breast and Ovarian Cancer Syndrome (Joint with the Committee on Genetics
            and the Society of Gynecologic Oncologists)                                         1533
     *104 Antibiotic Prophylaxis for Gynecologic Procedures                                     1543
     *108 Polycystic Ovary Syndrome                                                             1553
     *109 Cervical Cytology Screening                                                           1567


P OLICY S TATEMENTS
      AAFP—ACOG Joint Statement on Cooperative Practice and Hospital Privileges
        (July 1980, Revised and Retitled, March 1998)                                           1581
      Abortion Policy (January 1993, Reaffirmed July 2007)                                      1583
      Access to Women’s Health Care (July 1988, Reaffirmed July 2009)                           1586
      Certification and Procedural Credentialing (February 2008)                                1587
      Cervical Cancer Prevention in Low-Resource Settings (March 2004)                          1589
      Home Births in the United States (May 4, 2007)                                            1591
      Joint Statement of ACOG/AAP on Human Immunodeficiency
        Virus Screening (May 1999, Reaffirmed July 2006)                                        1592
      Joint Statement of Practice Relationships Between Obstetrician–Gynecologists
        and Certified Nurse-Midwives/Certified Midwives (October 2002)                          1594
      Midwifery Education and Certification (February 2006, Amended February 2007)              1595
      The Role of Obstetrician-Gynecologists in Cosmetic Procedures (November 2008)             1596
      Tobacco Marketing Aimed at Women and Adolescents
        (July 1990, Amended July 2009)                                                          1597


A PPENDIX C ONTENTS F ROM O THER C OLLEGE R ESOURCES
      Guidelines for Perinatal Care, Sixth Edition                                              1601
      Guidelines for Women’s Health Care, Third Edition                                         1603
      Health Care For Adolescents                                                               1604
      Special Issues in Women’s Health                                                          1604
      Committee Opinions List of Titles                                                         1605
      Practice Bulletins List of Titles                                                         1611




*Published in 2009
Foreword
The Compendium of Selected Publications CD-ROM is a compilation of all Committee Opinions, Practice Bulletins,
Policy Statements, and Technology Assessments current as of December 31, 2009:
     •   Committee Opinions: Brief focused documents that address clinical issues of an urgent or emergent
         nature or nonclinical topics such as policy, economics, and social issues that relate to obstetrics and
         gynecology. They are consensus statements that may or may not be based on scientific evidence.
     •   Practice Bulletins: Evidence-based guidelines developed to indicate a preferred method of diagnosis
         and management of a condition. The evidence is graded, and peer-reviewed research determines the
         recommendations in the document.
     •   Policy Statements: Position papers on key issues approved by the Executive Board.
     •   Technology Assessments in Obstetrics and Gynecology: Documents that describe specific technolo-
         gies and their application.
      These series are developed by committees of experts and reviewed by leaders in the specialty and the College.
Each document is reviewed periodically and either reaffirmed, replaced, or withdrawn to ensure its continued
appropriateness to practice. The contribution of the many groups and individuals who participated in the process is
gratefully acknowledged.
    Each section of the Compendium is devoted to a particular series, and includes those documents considered
current at the time of publication. A comprehensive table of contents has been added for ease of use with titles listed
numerically by committee. Those published within 2009 are indicated with an asterisk. Also provided are current
Committee Opinion and Practice Bulletin lists of titles, grouped by committee in order of publication.
    As the practice of medicine evolves, so do College documents. As a part of the continuing process of review
and revision, many documents initially published as a separate installment of a series evolve to become a part of a
broader effort to educate and inform our Fellows. Books such Guidelines for Perinatal Care or Guidelines for Women’s
Health Care carry equal weight as practice guidelines and should be considered adjuncts to the documents in the series.
For ease of reference, the contents of these volumes are included in the appendix.
    The Compendium of Selected Publications CD-ROM and the companion 2010 Compendium of Selected
Publications, which includes only 2008–2009 series documents current as of December 31, 2009, can be purchased by
calling 800-762-2264 (Compendium CD-ROM only: $104, $59 [members]; 2010 Compendium and CD-ROM: $226,
$99 [members]).
    Throughout the year, new documents will be published in the College’s official journal, Obstetrics & Gynecology.
Single copies can be obtained from the Resource Center (202-863-2518), and the series are available for sale as
complete sets or subscriptions (call 800-762-2264 to order). These documents also are available to members on our web
site: www.acog.org. To verify the status of documents, contact the Resource Center or check our web site.
    We are making every effort to provide health professionals with current, quality information on the practice of
obstetrics and gynecology. The Compendium of Selected Publications CD-ROM and the 2010 Compendium of Selected
Publications represent still other ways to disseminate material designed to promote women’s health.

—Ralph W. Hale, MD, Executive Vice President




                                                                                                                          xi
xii      COMPENDIUM OF SELECTED PUBLICATIONS




The Scope of Practice of
Obstetrics and Gynecology
Obstetrics and gynecology is a discipline dedicated to the broad, integrated medical and surgical
care of women’s health throughout their lifespan. The combined discipline of obstetrics and gyne-
cology requires extensive study and understanding of reproductive physiology, including the phys-
iologic, social, cultural, environmental and genetic factors that influence disease in women. This
study and understanding of the reproductive physiology of women gives obstetricians and gyne-
cologists a unique perspective in addressing gender-specific health care issues.

Preventive counseling and health education are essential and integral parts of the practice of obste-
tricians and gynecologists as they advance the individual and community-based health of women
of all ages.

Obstetricians and gynecologists may choose a scope of practice ranging from primary ambulatory
health care to concentration in a focused area of specialization.

                                                                  Approved by the Executive Board
                                                                                 February 6, 2005
Code of Professional Ethics
                                                                of the American College of
                                                           Obstetricians and Gynecologists

                     Obstetrician-gynecologists, as members of the medical profession, have ethical responsibili-
                     ties not only to patients, but also to society, to other health professionals and to themselves.
                     The following ethical foundations for professional activities in the field of obstetrics and
                     gynecology are the supporting structures for the Code of Conduct. The Code implements
                     many of these foundations in the form of rules of ethical conduct. Certain documents of the
                     American College of Obstetricians and Gynecologists also provide additional ethical rules,
                     including documents addressing the following issues: seeking and giving consultation,
                     informed consent, sexual misconduct, patient testing, human immunodeficiency virus, rela-
                     tionships with industry, commercial enterprises in medical practice, and expert testimony.
                     Noncompliance with the Code, including the above-referenced documents, may affect an
                     individual’s initial or continuing Fellowship in the American College of Obstetricians and
                     Gynecologists. These documents may be revised or replaced periodically, and Fellows should
                     be knowledgeable about current information.
                     Ethical Foundations
                       I. The patient–physician relationship: The welfare of the patient (beneficence) is central
                          to all considerations in the patient–physician relationship. Included in this relation-
                          ship is the obligation of physicians to respect the rights of patients, colleagues, and
                          other health professionals. The respect for the right of individual patients to make
                          their own choices about their health care (autonomy) is fundamental. The principle of
                          justice requires strict avoidance of discrimination on the basis of race, color, religion,
                          national origin, or any other basis that would constitute illegal discrimination (justice).
                         II. Physician conduct and practice: The obstetrician–gynecologist must deal honestly
                             with patients and colleagues (veracity). This includes not misrepresenting himself or
                             herself through any form of communication in an untruthful, misleading, or decep-
                             tive manner. Furthermore, maintenance of medical competence through study,
                             application, and enhancement of medical knowledge and skills is an obligation of
                             practicing physicians. Any behavior that diminishes a physician’s capability to prac-
                             tice, such as substance abuse, must be immediately addressed and rehabilitative
                             services instituted. The physician should modify his or her practice until the dimin-
                             ished capacity has been restored to an acceptable standard to avoid harm to patients
409 12th Street, SW          (nonmaleficence). All physicians are obligated to respond to evidence of questionable
PO Box 96920                 conduct or unethical behavior by other physicians through appropriate procedures
Washington, DC 20090-6920    established by the relevant organization.



                                                                                                                        xiii
xiv   COMPENDIUM OF SELECTED PUBLICATIONS



      III. Avoiding conflicts of interest: Potential conflicts of interest are inherent in the practice of medicine.
           Physicians are expected to recognize such situations and deal with them through public disclosure.
           Conflicts of interest should be resolved in accordance with the best interest of the patient, respecting a
           woman’s autonomy to make health care decisions. The physician should be an advocate for the patient
           through public disclosure of conflicts of interest raised by health payer policies or hospital policies.
      IV.   Professional relations: The obstetrician–gynecologist should respect and cooperate with other physicians,
            nurses, and health care professionals.
       V.   Societal responsibilities: The obstetrician–gynecologist has a continuing responsibility to society as a
            whole and should support and participate in activities that enhance the community. As a member of soci-
            ety, the obstetrician–gynecologist should respect the laws of that society. As professionals and members
            of medical societies, physicians are required to uphold the dignity and honor of the profession.

      Code of Conduct
      I.    Patient–Physician Relationship
            1. The patient–physician relationship is the central focus of all ethical concerns, and the welfare of the
               patient must form the basis of all medical judgments.
            2. The obstetrician–gynecologist should serve as the patient’s advocate and exercise all reasonable
               means to ensure that the most appropriate care is provided to the patient.
            3. The patient–physician relationship has an ethical basis and is built on confidentiality, trust, and hon-
               esty. If no patient–physician relationship exists, a physician may refuse to provide care, except in
               emergencies. Once the patient–physician relationship exists, the obstetrician–gynecologist must
               adhere to all applicable legal or contractual constraints in dissolving the patient–physician relation-
               ship.
            4. Sexual misconduct on the part of the obstetrician–gynecologist is an abuse of professional power and
               a violation of patient trust. Sexual contact or a romantic relationship between a physician and a cur-
               rent patient is always unethical.
            5. The obstetrician–gynecologist has an obligation to obtain the informed consent of each patient. In
               obtaining informed consent for any course of medical or surgical treatment, the obstetrician–gyne-
               cologist must present to the patient, or to the person legally responsible for the patient, pertinent
               medical facts and recommendations consistent with good medical practice. Such information should
               be presented in reasonably understandable terms and include alternative modes of treatment and the
               objectives, risks, benefits, possible complications, and anticipated results of such treatment.
            6. It is unethical to prescribe, provide, or seek compensation for therapies that are of no benefit to the
               patient.
            7.   The obstetrician–gynecologist must respect the rights and privacy of patients, colleagues, and others
                 and safeguard patient information and confidences within the limits of the law. If during the process
                 of providing information for consent it is known that results of a particular test or other information
                 must be given to governmental authorities or other third parties, that must be explained to the
                 patient.
            8. The obstetrician–gynecologist must not discriminate against patients based on race, color, national
               origin, religion, or any other basis that would constitute illegal discrimination.

      II.   Physician Conduct and Practice
            1. The obstetrician–gynecologist should recognize the boundaries of his or her particular competencies
               and expertise and must provide only those services and use only those techniques for which he or she
               is qualified by education, training, and experience.
CODE OF PROFESSIONAL ETHICS        xv
                                                                                                                       XV




     2. The obstetrician–gynecologist should participate in continuing medical education activities to main-
        tain current scientific and professional knowledge relevant to the medical services he or she renders.
        The obstetrician–gynecologist should provide medical care involving new therapies or techniques only
        after undertaking appropriate training and study.
     3. In emerging areas of medical treatment where recognized medical guidelines do not exist, the obste-
        trician–gynecologist should exercise careful judgment and take appropriate precautions to protect
        patient welfare.
     4. The obstetrician–gynecologist must not publicize or represent himself or herself in any untruthful,
        misleading, or deceptive manner to patients, colleagues, other health care professionals, or the public.
     5. The obstetrician–gynecologist who has reason to believe that he or she is infected with the human
        immunodeficiency virus (HIV) or other serious infectious agents that might be communicated to
        patients should voluntarily be tested for the protection of his or her patients. In making decisions
        about patient-care activities, a physician infected with such an agent should adhere to the fundamen-
        tal professional obligation to avoid harm to patients.
     6. The obstetrician–gynecologist should not practice medicine while impaired by alcohol, drugs, or phys-
        ical or mental disability. The obstetrician–gynecologist who experiences substance abuse problems or
        who is physically or emotionally impaired should seek appropriate assistance to address these prob-
        lems and must limit his or her practice until the impairment no longer affects the quality of patient
        care.

III. Conflicts of Interest
     1. Potential conflicts of interest are inherent in the practice of medicine. Conflicts of interest should be
        resolved in accordance with the best interest of the patient, respecting a woman’s autonomy to make
        health care decisions. If there is an actual or potential conflict of interest that could be reasonably con-
        strued to affect significantly the patient’s care, the physician must disclose the conflict to the patient.
        The physician should seek consultation with colleagues or an institutional ethics committee to deter-
        mine whether there is an actual or potential conflict of interest and how to address it.
     2. Commercial promotions of medical products and services may generate bias unrelated to product
        merit, creating or appearing to create inappropriate undue influence. The obstetrician–gynecologist
        should be aware of this potential conflict of interest and offer medical advice that is as accurate, bal-
        anced, complete, and devoid of bias as possible.
     3. The obstetrician–gynecologist should prescribe drugs, devices, and other treatments solely on the
        basis of medical considerations and patient needs, regardless of any direct or indirect interests in or
        benefit from a pharmaceutical firm or other supplier.
     4. When the obstetrician–gynecologist receives anything of substantial value, including royalties, from
        companies in the health care industry, such as a manufacturer of pharmaceuticals and medical
        devices, this fact should be disclosed to patients and colleagues when material.
     5. Financial and administrative constraints may create disincentives to treatment otherwise recom-
        mended by the obstetrician–gynecologist. Any pertinent constraints should be disclosed to the
        patient.

IV. Professional Relations
    1. The obstetrician–gynecologist’s relationships with other physicians, nurses, and health care profes-
       sionals should reflect fairness, honesty, and integrity, sharing a mutual respect and concern for the
       patient.
     2. The obstetrician–gynecologist should consult, refer, or cooperate with other physicians, health care
        professionals, and institutions to the extent necessary to serve the best interests of their patients.
xvi   COMPENDIUM OF SELECTED PUBLICATIONS



      V.   Societal Responsibilities
           1. The obstetrician–gynecologist should support and participate in those health care programs, prac-
              tices, and activities that contribute positively, in a meaningful and cost-effective way, to the welfare of
              individual patients, the health care system, or the public good.
           2. The obstetrician–gynecologist should respect all laws, uphold the dignity and honor of the profes-
              sion, and accept the profession’s self-imposed discipline. The professional competence and conduct
              of obstetrician–gynecologists are best examined by professional associations, hospital peer-review
              committees, and state medical and licensing boards. These groups deserve the full participation and
              cooperation of the obstetrician–gynecologist.
           3. The obstetrician–gynecologist should strive to address through the appropriate procedures the status of
              those physicians who demonstrate questionable competence, impairment, or unethical or illegal behav-
              ior. In addition, the obstetrician–gynecologist should cooperate with appropriate authorities to prevent
              the continuation of such behavior.
           4. The obstetrician–gynecologist must not knowingly offer testimony that is false. The
              obstetrician–gynecologist must testify only on matters about which he or she has knowledge and
              experience. The obstetrician–gynecologist must not knowingly misrepresent his or her credentials.
           5. The obstetrician–gynecologist testifying as an expert witness must have knowledge and experience
              about the range of the standard of care and the available scientific evidence for the condition in ques-
              tion during the relevant time and must respond accurately to questions about the range of the stan-
              dard of care and the available scientific evidence.
           6. Before offering testimony, the obstetrician–gynecologist must thoroughly review the medical facts of
              the case and all available relevant information.
           7.   The obstetrician–gynecologist serving as an expert witness must accept neither disproportionate
                compensation nor compensation that is contingent upon the outcome of the litigation.




      Copyright © January 2008, The American College of Obstetricians and Gynecologists, 409 12th Street,
      SW, PO Box 96920, Washington, DC 20090-6920. This document provides rules for ethical conduct for
      obstetricians and gynecologists.
COMMITTEE OPINIONS
COMMITTEE   ON   ADOLESCENT HEALTH CARE
COMMITTEE OPINIONS
COMMITTEE   ON   ADOLESCENT HEALTH CARE
ACOG                                Committee
                                    Opinion
        Committee on
Adolescent Health Care




The Committee wishes to thank
Abigail English, JD; S. Paige       Number 302, October 2004
Hertweck, MD; Susan Kornetsky,
MPH; Audrey Rogers, PhD,
MPH; and John Santelli, MD,
MPH for their assistance in the
                                    Guidelines for Adolescent Health
development of this opinion. This
document reflects emerging clini-   Research
cal and scientific advances as of
the date issued and is subject to     ABSTRACT: The risks of exposure to violence, human immunodeficiency
change. The information should        virus, and other sexually transmitted diseases; alcohol, tobacco, and pre-
not be construed as dictating an      scribed and illicit drug use; and unintended pregnancy, among others, threat-
exclusive course of treatment or      en the health and well-being of adolescents in the United States. Research is
procedure to be followed.             needed in these and other areas to improve adolescent health care and to aid
Copyright © October 2004              in health policy decisions. Adolescents often are prevented from participating
by the American College of            in such research because of inadequate understanding of their legal status
Obstetricians and Gynecologists.      and the ethical considerations regarding their participation in research.
All rights reserved. No part of       There is confusion about what constitutes appropriate levels of protection for
this publication may be repro-        studies involving adolescents as research subjects and uncertainty about the
duced, stored in a retrieval sys-     need for parental permission. This document is designed to clarify the
tem, or transmitted, in any form      informed consent and parental permission issues as they pertain to adolescent
or by any means, electronic,          health research.
mechanical, photocopying,
recording, or otherwise, without
prior written permission from
the publisher.                      Background
Requests for authorization to       A basic criterion for ethical research is the protection of the rights and wel-
make photocopies should be          fare of people participating in research. The U.S. federal government has pro-
directed to:                        mulgated regulations that govern research involving human subjects when the
Copyright Clearance Center          research is supported, conducted, or otherwise subject to regulation by the
222 Rosewood Drive                  federal government (1). These federal regulations on protection of human
Danvers, MA 01923
(978) 750-8400
                                    subjects in research, known as the Code of Federal Regulations: Title 45-
                                    Public Welfare; Part 46: Protection of Human Subjects (45 CFR Part 46), pro-
ISSN 1074-861X                      vide for a nationwide system of local Institutional Review Boards (IRBs).
The American College of             These IRBs must review and approve all federally funded research involving
Obstetricians and Gynecologists     human subjects and are regulated by the Office for Human Research
409 12th Street, SW                 Protections in the Department of Health and Human Services. Most universi-
PO Box 96920
Washington, DC 20090-6920           ties and research institutions apply these regulations to privately funded
                                    research as well. These regulations serve as guidelines for IRB review and
                                    approval. They require that risks to research participants are minimized and
Guidelines for adolescent health    that they are reasonable relative to the anticipated benefits and the importance
research. ACOG Committee Opinion
No. 302. American College of        of the knowledge that may be expected to result from the research. The reg-
Obstetricians and Gynecologists.    ulations also require that the selection of research participants is equitable and
Obstet Gynecol 2004;104:899–902.    that informed consent is provided from each prospective research participant

                                                                                                                       3
4           COMPENDIUM OF SELECTED PUBLICATIONS



or the participant’s legally authorized representative.    minor can begin to consent (6). Researchers in ado-
Informed consent is the ability to understand the          lescent health should be familiar with current state
risks and benefits of one’s participation in a research    statutes regarding age of majority and emancipation,
activity and to authorize one’s participation in this      as well as with minor consent statutes. An up-to-date
activity freely (2). General requirements for in-          listing of these statutes can be found online at
formed consent are described in 45 CFR Part 46,            http://www.guttmacher.org/pubs/spib.html.
Section 116 (1). Finally, the regulations require that
the research plan makes adequate provisions for
ensuring the safety of research participants and that      Regulations
adequate provisions are made to protect the privacy        In the federal regulations governing research, chil-
of research participants and to maintain the confiden-     dren are defined in 45 CFR 46 Section 102(a) as
tiality of data. Subpart D of 45 CFR Part 46 contains      “persons who have not attained the legal age for
special protections for children who participate as        consent to treatments or procedures involved in the
subjects in research.                                      research, under the applicable law of the jurisdiction
     Research involving adolescents, especially            in which the research will be conducted”(1). This
regarding behaviors related to sexuality, often raises     definition refers to laws, primarily state laws related
questions about how to obtain adequate informed            to consent for treatment of minors, age of majority,
consent and protection of the research participants’       and emancipation status.
confidential receipt of health care services. The               Federal regulations governing human subject
Society for Adolescent Medicine provided early             research require parental permission and child
leadership to address these concerns. In 1995, they        assent for subjects who meet the regulatory defini-
led the development of consensus guidelines to pro-        tion of “children,” ie, those who are younger than the
mote the ethical conduct of health research involv-        state-mandated age at which people may give legal-
ing adolescents as research participants (3). The          ly effective informed consent for treatments or pro-
society recently issued a revised position statement       cedures involved in the research. Assent means a
to support the guidelines (4); the Society for             child has given affirmative agreement to participate
Adolescent medicine also established a code of             in research. Mere failure to object should not, absent
research ethics to encourage, enhance, and promote         affirmative agreement, be construed as assent.
ethical standards for the conduct of research in ado-      Assent is required when, in the judgment of the IRB,
lescent health (5).                                        the children are capable of providing it (1).The fed-
     When considering the legal complexities of ado-       eral regulations deliberately use the terms “permis-
lescent health research, it is important to recognize      sion” and “assent” to differentiate this process from
that the age of majority in almost every state is 18       the usual informed consent process. An individual
years, and all states recognize the concept of eman-       can provide consent only for himself or herself.
cipated minors, who generally are allowed to consent       Therefore, parents give only permission for their
for their own health care. In addition, every state has    child to be involved in research, not consent. Assent
enacted some minor consent laws that allow minors          recognizes the importance of the emerging capacity
to consent for their own health care, whether or not       of children to give informed consent for themselves,
they are legally emancipated. Such laws may be             as well as the ethical importance of obtaining their
based on the status of the minor or the services they      agreement to participate even if they are not legally
are seeking. Minors who may consent for their own          authorized to give informed consent.
health care based on their status include those who             In 1977, the National Commission for the
are married, are members of the armed forces, live         Protection of Human Subjects of Biomedical and
apart from their parents, and are parents of a child. In   Behavioral Research recommended that individual
addition, all states allow adolescents who are minors      IRBs be allowed to determine that parental permis-
to consent for some categories of health care such as      sion is not appropriate in certain research studies,
sexually transmitted disease (STD) services (all           including research involving assessment for or care
states), drug and alcohol care (almost all states), con-   related to contraception and drug abuse (7).
traceptive services and pregnancy related care (a          According to the federal regulations (1), informed
majority of states), outpatient mental health counsel-     consent may be waived under 45 CFR Part 46
ing (about one half of states), or sexual assault care     Section 116(d) and parental permission may be
(a few states). Some states specify the age at which a     waived under 45 CFR Part 46 Section 408(c).
COMMITTEE OPINIONS               5



     Four criteria set forth by 45 CFR Part 46 116(d)     adolescents. It is important to note that if these sur-
allow an IRB to waive the requirement to obtain the       veys are conducted in a school setting, federal edu-
informed consent for adult research subjects or per-      cational law governing certain research conducted in
mission of a parent or guardian for research subjects     schools may apply. Health researchers working in
who are children if: 1) the research involves no more     schools are, therefore, advised to become knowl-
than “minimal risk” (which means that the probabil-       edgeable about these laws.
ity and magnitude of harm or discomfort anticipated            Section 408(c) of 45 CFR Part 46 also may be
in the research are not greater in and of themselves      used to waive parental permission for research areas
than those ordinarily encountered in daily life or        including STDs, birth control usage, high-risk
during the performance of routine physical or psy-        behaviors, HIV prevention, and situations in which
chologic examinations or tests [1]), 2) the waiver        obtaining parental consent may be dangerous to the
will not adversely affect the rights and welfare of the   child (abuse situations). Finally, in certain research
subjects, 3) the research could not practically be car-   studies, adolescent minors would not be considered
ried out without a waiver, and 4) whenever appropri-      children and parental permission would not be
ate, the subjects will be provided with additional        required. Such research includes certain clinical
pertinent information after participation (1). This       studies involving pregnancy, family planning, and
section is commonly used when waiving informed            treatment of STDs where the adolescent minor can
consent for research involving existing data such as      legally consent to such services. Again, familiarity
medical records.                                          with current state statutes on the rights of minors to
     In addition, 45 CFR Part 46 Section 408(c)           consent to health care services is essential.
specifically allows for a waiver of parental permis-           Researchers conducting and IRBs reviewing
sion under Subpart D, which addresses research with       research involving adolescents should be knowl-
children. Section 408(c) of 45 CFR Part 46 states:        edgeable of the federal regulations and the ethical
“…if an IRB determines that a research protocol is        principles that underlie these regulations. They
designed for conditions or a subject population for       should understand when parental permission is
which parental permission is not a reasonable             required and when it may be waived. Personal
requirement to protect subjects (eg, neglected or         beliefs and attitudes should not enter into this deci-
abused children), it may waive consent requirements       sion. The Society for Adolescent Medicine’s
provided an appropriate mechanism for protecting          Guidelines for Adolescent Health Research (4) pro-
the children who will participate as research subjects    vide a comprehensive approach to understanding
is substituted and provided the waiver is not incon-      these issues. Parental permission should not be a
sistent with federal, state, or local law…. The choice    barrier to the inclusion of adolescents in studies that
of an appropriate mechanism would depend on the           meet federal regulations and are designed to
nature and purpose of the activities described in the     improve their health.
protocol, the risk and anticipated benefit to the
research subjects, and their age, maturity, status, and
condition” (1). In discussing the waiver of parental      Conclusions
permission, the National Commission cited as exam-
ples of when the requirement might not be a reason-        1. Researchers developing study protocols and
able one: “…[r]esearch designed to identify factors           materials for submission for IRB review and
related to the incidence or treatment of certain con-         approval and the IRBs themselves should be
ditions in adolescents for which, in certain jurisdic-        familiar with, and adhere to, current federal reg-
tions, they legally may receive treatment without             ulations, 45 CFR Part 46 (1), and federal and
parental consent; [and] research in which the sub-            state laws that affect research (including laws
jects are ‘mature minors’ and the procedures                  regarding age of majority and emancipation,
involved entail essentially no more than minimal              minor consent statutes, and federal educational
risk that such individuals might reasonably assume            law governing certain research conducted in
on their own…” (7).                                           schools).
     Based on these criteria, either 45 CFR Part 46        2. Investigators will communicate better with IRB
Section 408(c) or 45 CFR Part 46 Section 116(d)               panels regarding the involvement of adolescent
may be used to waive parental permission in a vari-           participants in research if they understand the
ety of studies, including, for example, surveys of            purpose of human subject protection regulations
6               COMPENDIUM OF SELECTED PUBLICATIONS



       with respect to minors and review the guidelines              2. American College of Obstetricians and Gynecologists.
       provided by the Society for Adolescent                           Ethics in obstetrics and gynecology. 2nd ed. ACOG:
                                                                        Washington, DC; 2004.
       Medicine (3–5).                                               3. Guidelines for adolescent health research. 1995. Society
    3. Under the following circumstances it is reason-                  for Adolescent Medicine. J Adolesc Health 2003;33:
       able to waive parental permission when adoles-                   410–5.
       cents are involved in studies: a) the waiver                  4. Santelli JS, Smith Rogers A, Rosenfeld WD, DuRant RH,
                                                                        Dubler N, Morreale M, et al. Guidelines for adolescent
       would not adversely affect the rights and wel-                   health research: A position paper of the Society for
       fare of the adolescent, b) the study poses no                    Adolescent Medicine. J Adolesc Health 2003;33:
       more than a minimal risk to adolescents, c) the                  396–409.
       study could not be practically carried out with-              5. Code of Research Ethics: position paper of the Society for
       out a waiver, and d) requiring permission may                    Adolescent Medicine. J Adolesc Health 1999;24:277–82;
                                                                        discussion 283.
       not be reasonable to protect subjects. Parental               6. English A, Kenney KE. State minor consent laws: a sum-
       permission is not a requirement for research                     mary. 2nd Ed. Chapel Hill (NC): Center for Adolescent
       involving the provision of health care for which                 Health & the Law; 2003.
       adolescents do not legally need parental con-                 7. The National Commission for the Protection of Human
       sent. It is important to review 45 CFR Part 46                   Subjects of Biomedical and Behavioral Research.
                                                                        Research involving children: report and recommenda-
       for the necessary details.                                       tions. Bethesda (MD): U.S. Department of Health Educa-
                                                                        tion and Welfare; 1977.

References
    1. Protection of human subjects. 45 C.F.R §46 (2003). Avail-
       able at http://www.access.gpo.gov/nara/cfr/cfr-tablesearch.
       html#page1. Retrieved July 8, 2004.
COMMITTEE OPINIONS               7




ACOG                                  Committee
                                      Opinion
 ACOG Committee on
Adolescent Health Care



This document reflects emerging
clinical and scientific advances as
of the date issued and is subject
                                      Number 310, April 2005
to change. The information
should not be construed as dictat-
ing an exclusive course of treat-
ment or procedure to be followed.
                                      Endometriosis in Adolescents
The Committee wishes to thank           ABSTRACT: Historically thought of as a disease that affects adult women,
Marc R. Laufer, MD; Joseph              endometriosis increasingly is being diagnosed in the adolescent population.
Sanfilippo, MD; and Jonathon            This disorder, which was originally described more than a century ago, still
Solnik, MD; for their assistance        represents a vague and perplexing entity that frequently results in chronic
in the development of this docu-        pelvic pain, adhesive disease, and infertility. The purpose of this Committee
ment.                                   Opinion is to highlight the differences in adolescent and adult types of
                                        endometriosis. Early diagnosis and treatment during adolescence may decrease
Copyright © April 2005                  disease progression and prevent subsequent infertility.
by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of
this publication may be repro-        Incidence
duced, stored in a retrieval sys-
tem, or transmitted, in any form      It has been difficult to establish accurate prevalence rates of endometriosis in
or by any means, electronic,          adult and adolescent women. Documented rates in adolescent patients under-
mechanical, photocopying,             going laparoscopy for chronic pelvic pain range from 19% to 73%. Goldstein
recording, or otherwise, without      et al (1) reported a 47% prevalence of endometriosis found at laparoscopy in
prior written permission from
the publisher.
                                      a prospective study of adolescent females with pelvic pain. Other studies have
                                      shown that 25–38% of adolescents with chronic pelvic pain have endometrio-
Requests for authorization to         sis (2, 3). In addition, it has been shown that 50–70% of adolescents with
make photocopies should be
directed to:
                                      pelvic pain not responding to combination hormone therapy (such as oral
                                      contraceptive pills [OCPs]) and nonsteroidal antiinflammatory drugs
Copyright Clearance Center            (NSAIDs) have endometriosis at the time of laparoscopy (4, 5).
222 Rosewood Drive
Danvers, MA 01923
                                           Endometriosis also has been identified in premenarcheal girls who have
(978) 750-8400                        started puberty and have some breast development (6, 7). The occurrence of
                                      endometriosis before menarche contributes to the argument that one etiology
ISSN 1074-861X
                                      for endometriosis lies in the theory of embryonic müllerian rests or coe-
The American College of               lomic metaplasia as opposed to retrograde menses. Based on the occurrence
Obstetricians and Gynecologists       of early endometriosis, some authors have argued that “thelarche be recog-
409 12th Street, SW
PO Box 96920
                                      nized as a developmental benchmark, after which endometriosis is included
Washington, DC 20090-6920             in the differential diagnosis of chronic pelvic pain” (6).
                                           It is common for adult women who have endometriosis to bring in their
                                      adolescent daughters for evaluation and early diagnosis. Data from the
Endometriosis in adolescents. ACOG    Endometriosis Association indicate that 66% of adult women reported the
Committee Opinion No. 310.
American College of Obstetricians     onset of pelvic symptoms before age 20 years. Forty-seven percent of these
and Gynecologists. Obstet Gynecol     women reported they had to see a doctor five times or more before receiving
2005;105:921–7.                       the diagnosis of endometriosis or referral. As the age of the onset of symp-
8           COMPENDIUM OF SELECTED PUBLICATIONS



toms decreases, the number of doctors having to be            When evaluating an adolescent for suspected
seen to reach a diagnosis increases. Specifically, an    endometriosis or dysmenorrhea, the clinician should
average of 4.2 doctors were seen for patients whose      aim to rule out a pelvic mass or a congenital anom-
symptoms began before age 15 years compared with         aly of the reproductive tract. A bimanual examina-
an average of 2.64 doctors for patients whose symp-      tion may not be necessary to evaluate pelvic pain,
toms began between the ages of 30 years and 34           especially in adolescents who are virgins. If a bi-
years. There are, on average, 9.28 years from the        manual examination cannot be performed or is
onset of symptoms to the diagnosis (8). Endome-          declined, a rectal–abdominal examination in the dor-
triosis is believed to be a progressive disease be-      sal lithotomy position may be helpful to determine if
cause the prevalence and severity of the stage of the    a pelvic mass is present, and a cotton-tipped swab
disease significantly increase with age (9, 10). With    can be inserted into the vagina to evaluate for the
early diagnosis and treatment, it is hoped that dis-     presence of a transverse vaginal septum, vaginal
ease progression and infertility can be limited, but     agenesis, or agenesis of the lower vagina. If a biman-
this remains to be proved with prospective research.     ual examination is performed, the clinician should
                                                         check for the existence of both diffuse and focal
                                                         pelvic tenderness, and evaluate the pelvis for a dis-
Presentation and Characteristics                         placed uterus or an adnexal mass. An ultrasound
The typical presentation of an adolescent with           examination may be helpful in evaluating the pelvis
endometriosis may be different from that of an adult.    of a young adolescent who declines a bimanual or
One significant difference is that adolescents pri-      rectal–abdominal examination.
marily seek medical attention because of pain rather
than a concern for infertility. The most common          Imaging Studies and Serum Markers
symptom noted among published reviews is                 Ultrasonography and magnetic resonance imaging
acquired or progressive dysmenorrhea, which was          are helpful in evaluating anatomical structures, but
encountered in 64–94% of patients (4, 11). Other         are not specific for diagnosing endometriosis. An
common symptoms included acyclic pain (36–91%),          adolescent will rarely have a pelvic mass from an
dyspareunia (14–25%), and gastrointestinal com-          endometrioma or uterosacral nodularity. CA 125,
plaints (2–46%) (11). Adolescents found to have          although very sensitive, is not specific and, thus, is
endometriosis most commonly present with both            not helpful in the diagnosis of adolescent endo-
cyclic and acyclic pain (62.6%), as opposed to           metriosis. No data exist regarding the use of CA 125
acyclic pain alone (28.1%), or cyclic pain alone         to monitor the clinical progression or regression of
(9.4%) (11).                                             disease in adolescents with endometriosis.
     In young women, pelvic pain associated with
endometriosis often interferes with school atten-        Empiric Therapy
dance as well as physical and social activities.
Prompt diagnosis and adequate therapy, therefore,        If an adolescent younger than 18 years has persistent
may return normal psychosocial development and           pain while taking combination hormone therapy and
self-esteem, improve scholastic performance, and         NSAIDs, endometriosis should be suspected and she
lead to a return to normal daily activities.             should be offered a laparoscopic evaluation (discus-
                                                         sion follows in section on “Surgical Diagnosis”). If,
                                                         however, she is older than 18 years and had a nega-
Diagnosis                                                tive assessment for an ovarian mass or tumor, she
                                                         can be offered an empiric trial of gonadotropin-
History and Physical Examination                         releasing hormone (GnRH) agonist therapy (12, 13).
A thorough review of history and physical examina-       If the pain subsides with the use of GnRH agonist,
tion are necessary to assess a variety of differential   then a diagnosis of endometriosis can be made. An
diagnoses of pelvic pain such as appendicitis, pelvic    empiric trial of GnRH agonist is not routinely
inflammatory disease, müllerian anomalies or out-        offered to patients younger than 18 years because
flow obstruction, bowel disease, hernias, musculo–       the effects of these medications on bone formation
skeletal disorders, and psychosocial complaints.         and long-term bone density have not been ade-
Pelvic examination may be difficult, especially in       quately studied. For patients younger than 18 years
patients who have not had vaginal intercourse.           or who decline empiric therapy, diagnostic and ther-
COMMITTEE OPINIONS                     9



apeutic laparoscopy can be initiated. An algorithm                           ommended for diagnosing and treating presumed
for therapy is provided in Figure 1 (14).                                    endometriosis in an adolescent. Laparoscopy can be
                                                                             safely performed in adolescents. At the time of sur-
Surgical Diagnosis                                                           gical diagnosis, most adolescents have Stage I dis-
After a comprehensive preoperative evaluation and                            ease as classified by the American Society for
trial of combination hormone therapy and NSAIDs                              Reproductive Medicine classification system (15).
to treat dysmenorrhea, laparoscopy should be rec-                            Goldstein et al commented that almost 60% of the

                                                                  History
                                                           Physical examination
                                                        Consider radiologic imaging
                                                                Pain diary



                                                          Cyclic CHT and NSAIDs

                                                  If persistent pain                 Empiric GnRH agonist (if older than 18 years)
                                                                                     If improved—diagnosis is endometriosis

                                                              Laparoscopy
                                          Diagnosis of endometriosis by visualization or biopsy
                                              Surgical treatment (ablation/resection/laser)
                                                            of endometriosis



         Endometriosis identified visually or by pathology                       No endometriosis—visually and histologically negative

                     <16 years                     >16 years



             Continuous CHT                                    GnRH agonist                 Gastrointestinal or urologic evaluation
                                    Symptoms persist           (± add-back)*                      Pain management service
                                                                    OR
                                                              Continuous CHT



                                                              Continuous CHT

                                                   No pain                         Continued pain


                                             Continue CHT                       Laparoscopy with resection of endometriosis
                                                                                                  and/or
                                                                                  Long-term GnRH agonist with add-back
                                                                                                   and
                                                                                        Pain management service
                                                                                  Complementary or alternative therapies

  Abbreviations: NSAIDs, nonsteroidal antiinflammatory drugs; CHT, combination hormone therapy (oral contraceptive pills, estrogen/progestin
  patch, estrogen/progestin vaginal ring, norethindrone acetate, medroxyprogesterone acetate); GnRH, gonadotropin-releasing hormone.
  *Add-back indicates use of estrogen and progestin or norethindrone acetate alone.



Fig. 1. Protocol for evaluation and treatment of adolescent pelvic pain and endometriosis. (Modified with permission
from Bandera CA, Brown LR, Laufer MR. Adolescents and endometriosis. Clin Consult Obstet Gynecol 1995;7:206.)
10          COMPENDIUM OF SELECTED PUBLICATIONS



patients in their cohort had Stage I disease (1),          of endometriosis. The goal of therapy for adolescent
whereas 80% of the cases reported by other                 endometriosis should be suppression of pain, sup-
researchers had minimal to mild disease (4).               pression of disease progression, and preservation of
Gynecologic surgeons who perform laparoscopy in            fertility. Consequently, after surgery, all adolescents
adolescents with pelvic pain should be familiar with       who have endometriosis should be treated with med-
the typical lesions of endometriosis in adolescents,       ical therapy until they have completed child bearing
which tend to be red, clear, or white (15) as opposed      to suppress pain, progression of disease, and result-
to the powder-burn lesions seen commonly in adults         ing potential infertility.
who have endometriosis. The use of a liquid medium              First-line treatment modalities should involve
in the pelvis may facilitate the identification of clear   the use of NSAIDs and hormone therapy. Because
lesions, which are very common in adolescents (11).        red lesions have been shown to be active producers
                                                           of prostaglandins, and adolescents with endometrio-
Müllerian Anomalies and Endometriosis                      sis typically report severe dysmenorrhea, NSAIDs
The development of endometriosis in adolescent             may be used in conjunction with hormonal men-
patients has been associated with müllerian anom-          strual suppressive therapy to provide sufficient
alies with outflow tract obstruction. The published        relief. Most pharmacologic agents bring about relief
incidence of anomalies of the reproductive system          by inducing an anovulatory or a hypoestrogenic
and associated endometriosis has been reported to          state or both. Continuous combination hormone
be as high as 40%, but most studies quote a rate of        therapy (OCPs, combination hormonal contracep-
5–6%. The clinical outcome in patients with outflow        tive patch, or vaginal ring) for menstrual suppression
tract obstructions has been reported to differ from        can be used to create a “pseudopregnancy” state,
those without such obstruction because regression of       which was described more than 40 years ago (17).
disease usually has been observed once surgical cor-       This method routinely has been promoted for ado-
rection of the anomaly has been accomplished (16).         lescents who have endometriosis. Although this
                                                           method may provide effective relief, the Cochrane
                                                           Database Review 2003 provided data suggesting
Treatment                                                  that further studies are needed to prove long-term
The premise for treating the symptomatic adolescent        benefits (18). Most clinicians advocate continuous
is based on the concept that endometriosis has been        use of combination hormone therapy to induce
shown to be a progressive disease without a known          amenorrhea, but this modality can result in signifi-
cure. A physician treating an adolescent with endo-        cant breakthrough bleeding. One randomized con-
metriosis should adopt a multidimensional approach         trolled trial compared a 28-day regimen with contin-
and consider the use of the following components:          uous combination oral contraceptives and found no
surgery, hormonal manipulation, pain medications,          increase in spotting days after 9 months of therapy,
mental health support, complementary and alterna-          with fewer total bleeding days in the group taking
tive therapies, and education.                             continuous combination oral contraceptives (19).
     Patients younger than 18 years with persistent        Thus, continuous use of combination hormone ther-
pelvic pain while taking combination hormone ther-         apy is believed to be both safe and effective for ado-
apy should routinely be offered a laparoscopic pro-        lescents with endometriosis-related pain and, thus, is
cedure for diagnosis and surgical management of            the first-line hormone therapy for adolescents
endometriosis. The gynecologic surgeon must be             younger than 16 years with endometriosis. Gonado-
familiar with the appearance of endometriosis in           tropin-releasing hormone agonists are not offered as
adolescents and should remove or destroy all visi-         first-line therapy for adolescents in this age range.
ble lesions of endometriosis. Only procedures that              Progestin-only protocols have been used for the
preserve fertility options should be applied; oophor-      treatment of adult endometriosis with mixed results.
ectomy or hysterectomy should not be offered to            In a recent critical review, progestins were shown to
adolescents.                                               be as effective as danazol or GnRH agonists (20).
     Long-term follow-up studies of treatments for         Common side effects include irregular bleeding and
adolescent endometriosis have not been performed.          weight gain. Some studies suggest that these side
Current treatments for adolescents have been extrap-       effects are well tolerated (20), however in a data set
olated and adapted from the literature of adult cases      of 3,751 women who have endometriosis, treatment
COMMITTEE OPINIONS              11



with medroxyprogesterone acetate or depot medroxy-           progesterone acetate (0.625/2.5 mg per day) can
progesterone acetate was the least well tolerated and        help preserve bone density (26, 27). Add-back ther-
was the least effective in treating pain compared            apy has been shown not to influence the primary
with combination OCPs, GnRH agonists, and pain               therapeutic effect and resulted in less bone loss
medications (8). Furthermore, depot medroxyprog-             12 months after cessation of therapy in adult
esterone acetate used for longer than 2 years has            women. There is some evidence in adults to suggest
been shown to decrease bone density in adolescents           that immediate add-back therapy may result in even
(21, 22, 23). The U.S. Food and Drug Administra-             less bone loss (28). No data exist on the long-term
tion has warned against the long-term use of depot           effects of GnRH agonist use with add-back therapy
medroxyprogesterone acetate because of adverse               in the adolescent population and, thus, it should be
affects on bone density (24).                                reserved for adolescents refractory to continuous
     Danazol, an androgenic and antiestrogenic               combination hormone therapy (14, 29). Lifestyle
agent, is extremely effective in treating symptomatic        modifications, such as adequate physical exercise
endometriosis in adults. Doses of 400–800 mg daily           and calcium and vitamin D intake, also are essential
have been advocated for 6 months followed by con-            to maintaining proper bone health when taking
tinuous OCP use for maintenance suppression of the           GnRH agonists (with or without add-back therapy).
hypothalamic–pituitary ovarian axis. This choice of               Aside from medical management, surgery also
pharmacotherapy was more common in the 1980s,                has proved to be an effective form of treatment for
but the androgenic side effects have made this a poor        adult patients with pain (30). Surgery for the man-
option for adolescents.                                      agement of endometriosis-related pain is an impor-
     Gonadotropin-releasing hormone agonists cre-            tant option for adolescents, but clearly, radical
ate a hypoestrogenic state by downregulating the             procedures (oophorectomy, bilateral oophorectomy,
hypothalamic–pituitary axis. Whereas these agents            or hysterectomy) should be avoided in this age
are greatly effective in the treatment of endometrio-        group, even in rare cases of severe endometriosis. A
sis-related pain in adolescents, their use alone (with-      double-blinded randomized controlled trial com-
out add-back therapy described in the following              pared laser vaporization of endometriosis and laser
paragraph) usually is limited to 6 months because of         uterosacral nerve ablation with controls in 63 adult
the resultant profound hypoestrogenic state and its          patients with proven endometriosis. At 6 months of
subsequent effect on bone mineralization. This is a          follow-up, 63% of patients reported significant relief
major issue for an adolescent who is accruing peak           compared with 23% of controls (31). Patients with
bone mineral density. Therefore, it has been suggest-        more advanced disease had better outcomes in pain
ed that this therapy not be offered as a first-line treat-   management compared with those with minimal dis-
ment for adolescents younger than 16 years (14). At          ease. At 1-year follow-up, 90% of those in the treat-
6 months, GnRH agonist induces a 5% loss in tra-             ment arm who initially responded had continued
becular bone mineral density and a 2% loss in                pain relief (32). Among the symptomatic controls,
femoral neck bone mineral density in adult women.            an even distribution of patients was noted to have
In a cross-sectional study, researchers collected bone       progression, regression, and maintenance of disease.
mineral density test results of 265 females, aged            Both new and recurrent disease was noted at second
8–50 years (25). They determined that the majority           look. In a Cochrane review of these data, adult
of bone mass growth is achieved by age 20 years and          patients were almost 5 times more likely to benefit
that after the age 18 years, no significant differences      from surgical management of endometriosis com-
in bone mass or bone mineral density were noted at           pared with controls (33). One study demonstrated, in
most skeletal sites. This emphasizes that a drug-            a prospective review of 643 patients with pain, or
induced hypoestrogenic state could significantly             infertility, or both, that there was a significant rela-
affect peak bone mineralization that occurs during           tionship between pain and the depth of infiltration of
adolescence, particularly in females younger than 16         the endometriosis implants (9). This study also con-
years.                                                       firmed that red implants were more common in
     Investigators have determined that to reduce the        younger patients and that the depth of invasion
symptoms and bone loss related to a hypoestrogenic           increased with age, suggesting that endometriosis is
state, add-back therapy with norethindrone acetate           a progressive disease. The concept that endometrio-
(5 mg per day) or conjugated estrogens/medroxy-              sis is a progressive disease supports the recommen-
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.2010 acog compendium

  • 1. THE AMERICAN COLLEGE OF OBSTETRICIANS AND GYNECOLOGISTS W OMEN ’ S H EALTH C ARE P HYSICIANS COMPENDIUM of Selected Publications
  • 2. The Compendium of Selected Publications CD-ROM contains all Committee Opinions, Practice Bulletins, Policy Statements, and Technology Assessments published by the American College of Obstetricians and Gynecologists (the College) as of December 31, 2009. The information in these documents should not be viewed as establishing standards or dictating rigid rules. The guidelines are general and intended to be adapted to many different situations, taking into account the needs and resources particular to the locality, the institution, or the type of practice. Variations and innovations that improve the quality of patient care are to be encouraged rather than restricted. The purpose of these guidelines will be well served if they provide a firm basis on which local norms may be built. Copyright 2010 by the American College of Obstetricians and Gynecologists. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, posted on the Internet, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission from the publisher. The American College of Obstetricians and Gynecologists 409 12th Street, SW PO Box 96920 Washington, DC 20090-6920 ISBN: 978-1-934946-88-6 Publications can be ordered through the College Distribution Center by calling toll free 800-762-2264. To receive order forms via facsimile, call (732) 885-6364 and follow the audio instructions. Publications also can be ordered from the College web site at www.acog.org. The following resources from the College also contain College practice guidelines and should be considered adjuncts to the documents in the Compendium of Selected Publications CD-ROM. Guidelines for Perinatal Care, Sixth Edition Guidelines for Women’s Health Care, Third Edition Health Care for Adolescents Special Issues in Women’s Health These documents are available online to members at www.acog.org
  • 3. SEARCH Contents F OREWORD xi T HE S COPE OF P RACTICE OF O BSTETRICS AND G YNECOLOGY xii C ODE OF P ROFESSIONAL E THICS xiii C OMMITTEE O PINIONS C OMMITTEE ON A DOLESCENT H EALTH C ARE 302 Guidelines for Adolescent Health Research 3 310 Endometriosis in Adolescents 7 314 Meningococcal Vaccination for Adolescents 14 344 Human Papillomavirus Vaccination (Joint with the ACOG Working Group on Immunization) 17 349 Menstruation in Girls and Adolescents: Using the Menstrual Cycle as a Vital Sign (Joint with the American Academy of Pediatrics) 24 350 Breast Concerns in the Adolescent 30 351 The Overweight Adolescent: Prevention, Treatment, and Obstetric–Gynecologic Implications 38 355 Vaginal Agenesis: Diagnosis, Management, and Routine Care 50 392 Intrauterine Device and Adolescents 55 415 Depot Medroxyprogesterone Acetate and Bone Effects (Joint with Committee on Gynecologic Practice) 58 417 Addressing Health Risks of Noncoital Sexual Activities (Joint with Committee on Gynecologic Practice) 62 *448 Menstrual Manipulation for Adolescents with Disabilities 65 *451 Von Willebrand Disease in Women (Joint with Committee on Gynecologic Practice) 69 C OMMITTEE ON C ODING AND N OMENCLATURE 205 Tubal Ligation with Cesarean Delivery 77 249 Coding Responsibility 78 250 Inappropriate Reimbursement Practices by Third-Party Payers 79 C OMMITTEE ON E THICS 297 Nonmedical Use of Obstetric Ultrasonography 85 321 Maternal Decision Making, Ethics, and the Law 87 341 Ethical Ways for Physicians to Market a Practice 98 347 Using Preimplantation Embryos for Research 102 352 Innovative Practice: Ethical Guidelines 115 358 Professional Responsibilities in Obstetric–Gynecologic Education 122 *Published in 2009 iii
  • 4. iv COMPENDIUM OF SELECTED PUBLICATIONS C OMMITTEE ON E THICS (continued) 359 Commercial Enterprises in Medical Practice 126 360 Sex Selection 129 362 Medical Futility 133 363 Patient Testing: Ethical Issues in Selection and Counseling 137 364 Patents, Medicine, and the Interests of Patients (Joint with Committee on Genetics) 140 365 Seeking and Giving Consultation 145 368 Adoption 150 369 Multifetal Pregnancy Reduction 154 370 Institutional Responsibility to Provide Legal Representation 159 371 Sterilization of Women, Including Those With Mental Disabilities 161 373 Sexual Misconduct 165 374 Expert Testimony 169 377 Research Involving Women 171 385 The Limits of Conscientious Refusal in Reproductive Medicine 177 389 Human Immunodeficiency Virus 183 390 Ethical Decision Making in Obstetrics and Gynecology 189 395 Surgery and Patient Choice 198 397 Surrogate Motherhood 203 401 Relationships With Industry 209 403 End-of-Life Decision Making 215 409 Direct-to-Consumer Marketing of Genetic Testing (Joint with Committee on Genetics) 222 410 Ethical Issues in Genetic Testing (Joint with Committee on Genetics) 224 422 At-Risk Drinking and Illicit Drug Use: Ethical Issues in Obstetric and Gynecologic Practice 232 *439 Informed Consent 244 C OMMITTEE ON G ENETICS 318 Screening for Tay–Sachs Disease 255 324 Perinatal Risks Associated With Assisted Reproductive Technology (Joint with Committees on Obstetric Practice and Gynecologic Practice) 257 325 Update on Carrier Screening for Cystic Fibrosis 261 338 Screening for Fragile X Syndrome 265 393 Newborn Screening 268 399 Umbilical Cord Blood Banking (Joint with Committee on Obstetric Practice) 272 *430 Preimplantation Genetic Screening for Aneuploidy 275 *432 Spinal Muscular Atrophy 277 *442 Preconception and Prenatal Carrier Screening for Genetic Diseases in Individuals of Eastern European Jewish Descent 280 *446 Array Comparative Genomic Hybridization in Prenatal Diagnosis 284 *449 Maternal Phenylketonuria 287 1 Genetics and Molecular Diagnostic Testing 289 *Published in 2009 Technology Assessment
  • 5. CONTENTS v C OMMITTEE ON G YNECOLOGIC P RACTICE 240 Statement on Surgical Assistants (Joint with Committee on Obstetric Practice) 311 253 Nongynecologic Procedures 312 278 Avoiding Inappropriate Clinical Decisions Based on False-Positive Human Chorionic Gonadotropin Test Results 313 280 The Role of the Generalist Obstetrician–Gynecologist in the Early Detection of Ovarian Cancer (Joint with Society of Gynecologic Oncologists) 316 313 The Importance of Preconception Care in the Continuum of Women’s Health Care 319 319 The Role of the Obstetrician–Gynecologist in the Assessment and Management of Obesity 321 322 Compounded Bioidentical Hormones 326 323 Elective Coincidental Appendectomy 328 332 Hepatitis B and Hepatitis C Virus Infections in Obstetrician–Gynecologists 330 334 Role of the Obstetrician–Gynecologist in the Screening and Diagnosis of Breast Masses 332 336 Tamoxifen and Uterine Cancer 334 337 Noncontraceptive Uses of the Levonorgestrel Intrauterine System 338 345 Vulvodynia (Joint with American Society for Colposcopy and Cervical Pathology) 342 372 The Role of Cystourethroscopy in the Generalist Obstetrician–Gynecologist Practice 346 375 Brand Versus Generic Oral Contraceptives 350 378 Vaginal “Rejuvenation” and Cosmetic Vaginal Procedures 352 384 Colonoscopy and Colorectal Cancer Screening and Prevention 354 387 Pharmaceutical Compounding 358 388 Supracervical Hysterectomy 360 396 Intraperitoneal Chemotherapy for Ovarian Cancer 363 405 Ovarian Tissue and Oocyte Cryopreservation 366 407 Low Bone Mass (Osteopenia) and Fracture Risk 368 408 Professional Liability and Gynecology-Only Practice (Joint with Committees on Obstetric Practice and Professional Liability) 371 411 Routine Human Immunodeficiency Virus Screening 372 412 Aromatase Inhibitors in Gynecologic Practice 375 413 Age-Related Fertility Decline (Joint with American Society for Reproductive Medicine) 378 420 Hormone Therapy and Heart Disease 381 *434 Induced Abortion and Breast Cancer Risk 385 *440 The Role of Transvaginal Ultrasonography in the Evaluation of Postmenopasual Bleeding 387 *444 Choosing the Route of Hysterectomy for Benign Diseases 390 *450 Increasing Use of Contraceptive Implants and Intrauterine Devices to Reduce Unintended Pregnancy (Joint with the Long Acting Reversible Contraception Working Group) 393 *452 Primary and Preventive Care: Periodic Assessments 398 4 Hysteroscopy 406 5 Sonohysterography 410 *6 Robot-Assisted Surgery 413 *Published in 2009 Technology Assessment
  • 6. vi COMPENDIUM OF SELECTED PUBLICATIONS C OMMITTEE ON H EALTH C ARE FOR U NDERSERVED W OMEN 307 Partner Consent for Participation in Women’s Reproductive Health Research 419 312 Health Care for Homeless Women 422 316 Smoking Cessation During Pregnancy (Joint with Committee on Obstetric Practice) 428 317 Racial and Ethnic Disparities in Women’s Health 434 343 Psychosocial Risk Factors: Perinatal Screening and Intervention 438 361 Breastfeeding: Maternal and Infant Aspects (Joint with Committee on Obstetric Practice) 447 391 Health Literacy 449 414 Human Immunodeficiency Virus and Acquired Immunodeficiency Syndrome and Women of Color 452 416 The Uninsured 456 *423 Motivational Interviewing: A Tool for Behavior Change 460 *424 Abortion Access and Training 464 *425 Health Care for Undocumented Immigrants 468 *428 Legal Status: Health Impact for Lesbian Couples 472 *429 Health Disparities for Rural Women 476 *437 Community Involvement and Volunteerism 480 C OMMITTEE ON I NTERNATIONAL A FFAIRS *427 Misoprostol for Postabortion Care 485 C OMMITTEE ON O BSTETRIC P RACTICE 125 Placental Pathology 491 234 Scheduled Cesarean Delivery and the Prevention of Vertical Transmission of HIV Infection 492 260 Circumcision 495 267 Exercise During Pregnancy and the Postpartum Period 497 268 Management of Asymptomatic Pregnant or Lactating Women Exposed to Anthrax 500 275 Obstetric Management of Patients with Spinal Cord Injuries 503 276 Safety of Lovenox in Pregnancy 506 279 Prevention of Early-Onset Group B Streptococcal Disease in Newborns 508 281 Rubella Vaccination 516 284 Nonobstetric Surgery in Pregnancy 517 295 Pain Relief During Labor (Joint with American Society of Anesthesiologists) 518 299 Guidelines for Diagnostic Imaging During Pregnancy 519 305 Influenza Vaccination and Treatment During Pregnancy 524 315 Obesity in Pregnancy 526 326 Inappropriate Use of the Terms Fetal Distress and Birth Asphyxia 531 333 The Apgar Score (Joint with American Academy of Pediatrics) 533 339 Analgesia and Cesarean Delivery Rates 537 340 Mode of Term Singleton Breech Delivery 539 *Published in 2009
  • 7. CONTENTS vii C OMMITTEE ON O BSTETRIC P RACTICE (continued) 342 Induction of Labor for Vaginal Birth After Cesarean Delivery 542 346 Amnioinfusion Does Not Prevent Meconium Aspiration Syndrome 545 348 Umbilical Cord Blood Gas and Acid-Base Analysis 548 376 Nalbuphine Hydrochloride Use for Intrapartum Analgesia 552 379 Management of Delivery of a Newborn With Meconium-Stained Amniotic Fluid 553 381 Subclinical Hypothyroidism in Pregnancy 554 382 Fetal Monitoring Prior to Scheduled Cesarean Delivery 556 394 Cesarean Delivery on Maternal Request 557 402 Antenatal Corticosteroid Therapy for Fetal Maturation 561 404 Late-Preterm Infants 564 418 Prenatal and Perinatal Human Immunodeficiency Virus Testing: Expanded Recommendations 568 419 Use of Progesterone to Reduce Preterm Birth (Joint with Society for Maternal Fetal Medicine) 572 421 Antibiotic Prophylaxis for Infective Endocarditis 575 *433 Optimal Goals for Anesthesia Care in Obstetrics (Joint with American Society of Anesthesiologists) 577 *435 Postpartum Screening for Abnormal Glucose Tolerance in Women Who Had Gestational Diabetes Mellitus 580 *438 Update on Immunization and Pregnancy: Tetanus, Diphtheria, and Pertussis Vaccination 583 *441 Oral Intake During Labor 586 *443 Air Travel During Pregnancy 587 *445 Antibiotics for Preterm Labor (Joint with Society for Maternal Fetal Medicine) 589 C OMMITTEE ON P ROFESSIONAL L IABILITY 380 Disclosure and Discussion of Adverse Events (Joint with Committee on Patient Safety and Quality Improvement) 593 406 Coping With the Stress of Medical Professional Liability Litigation 595 C OMMITTEE ON PATIENT S AFETY AND Q UALITY I MPROVEMENT 320 Partnering With Patients to Improve Safety 599 327 “Do Not Use” Abbreviations 602 328 Patient Safety in the Surgical Environment 604 329 Tracking and Reminder Systems 609 331 Safe Use of Medication 612 353 Medical Emergency Preparedness 616 366 Disruptive Behavior 619 367 Communication Strategies for Patient Handoffs 621 398 Fatigue and Patient Safety 624 400 Technologic Advances to Reduce Medication-Related Errors 627 *447 Patient Safety in Obstetrics and Gynecology 631 *Published in 2009
  • 8. viii COMPENDIUM OF SELECTED PUBLICATIONS R EADING THE M EDICAL L ITERATURE 637 P RACTICE B ULLETINS C OMMITTEE ON P RACTICE B ULLETINS —O BSTETRICS 4 Prevention of Rh D Alloimmunization 647 6 Thrombocytopenia in Pregnancy 655 9 Antepartum Fetal Surveillance 666 12 Intrauterine Growth Restriction 677 13 External Cephalic Version 689 17 Operative Vaginal Delivery 696 19 Thromboembolism in Pregnancy 704 20 Perinatal Viral and Parasitic Infections 714 22 Fetal Macrosomia 727 24 Management of Recurrent Early Pregnancy Loss 738 29 Chronic Hypertension in Pregnancy 750 30 Gestational Diabetes 759 31 Assessment of Risk Factors for Preterm Birth 773 33 Diagnosis and Management of Preeclampsia and Eclampsia 781 36 Obstetric Analgesia and Anesthesia 790 37 Thyroid Disease in Pregnancy 805 38 Perinatal Care at the Threshold of Viability 815 40 Shoulder Dystocia 823 43 Management of Preterm Labor 829 44 Neural Tube Defects 838 48 Cervical Insufficiency 849 49 Dystocia and Augmentation of Labor 858 52 Nausea and Vomiting of Pregnancy 868 54 Vaginal Birth After Previous Cesarean Delivery 881 55 Management of Postterm Pregnancy 891 56 Multiple Gestation: Complicated Twin, Triplet, and High-Order Multifetal Pregnancy (Joint with Society for Maternal–Fetal Medicine) 899 60 Pregestational Diabetes Mellitus 914 68 Antiphospholipid Syndrome 925 71 Episiotomy 934 75 Management of Alloimmunization During Pregnancy 940 76 Postpartum Hemorrhage 948 77 Screening for Fetal Chromosomal Abnormalities (Joint with Committee on Genetics and the Society for Maternal–Fetal Medicine) 957 78 Hemoglobinopathies in Pregnancy 968 80 Premature Rupture of Membranes 977 *Published in 2009
  • 9. CONTENTS ix C OMMITTEE ON P RACTICE B ULLETINS —O BSTETRICS (continued) 82 Management of Herpes in Pregnancy 990 86 Viral Hepatitis in Pregnancy 1000 88 Invasive Prenatal Testing for Aneuploidy (Joint with Committee on Genetics) 1015 90 Asthma in Pregnancy 1024 92 Use of Psychiatric Medications During Pregnancy and Lactation 1032 95 Anemia in Pregnancy 1052 97 Fetal Lung Maturity 1059 *100 Critical Care in Pregnancy 1069 *101 Ultrasonography in Pregnancy 1077 *102 Management of Stillbirth 1088 *105 Bariatric Surgery and Pregnancy 1102 *106 Intrapartum Fetal Heart Rate Monitoring: Nomenclature, Interpretation, and General Management Principles 1111 *107 Induction of Labor 1122 251 Obstetric Aspects of Trauma Management 1134 C OMMITTEE ON P RACTICE B ULLETINS —G YNECOLOGY 11 Medical Management of Endometriosis 1143 14 Management of Anovulatory Bleeding 1156 15 Premenstrual Syndrome 1164 28 Use of Botanicals for Management of Menopausal Symptoms 1173 34 Management of Infertility Caused by Ovulatory Dysfunction 1184 35 Diagnosis and Treatment of Cervical Carcinomas 1196 39 Selective Estrogen Receptor Modulators 1209 42 Breast Cancer Screening 1219 46 Benefits and Risks of Sterilization 1231 50 Osteoporosis 1243 51 Chronic Pelvic Pain 1257 53 Diagnosis and Treatment of Gestational Trophoblastic Disease (Joint with Society of Gynecologic Oncologists) 1274 57 Gynecologic Herpes Simplex Virus Infections 1287 59 Intrauterine Device 1294 61 Human Papillomavirus 1304 63 Urinary Incontinence in Women 1318 65 Management of Endometrial Cancer (Joint with Society of Gynecologic Oncologists) 1331 67 Medical Management of Abortion 1344 69 Emergency Contraception 1356 72 Vaginitis 1367 73 Use of Hormonal Contraception in Women With Coexisting Medical Conditions 1379 *Published in 2009
  • 10. x COMPENDIUM OF SELECTED PUBLICATIONS C OMMITTEE ON P RACTICE B ULLETINS —G YNECOLOGY (continued) 81 Endometrial Ablation 1399 83 Management of Adnexal Masses 1415 84 Prevention of Deep Vein Thrombosis and Pulmonary Embolism 1429 85 Pelvic Organ Prolapse 1441 89 Elective and Risk-Reducing Salpingo-oophorectomy 1454 91 Treatment of Urinary Tract Infections in Nonpregnant Women 1465 93 Diagnosis and Management of Vulvar Skin Disorders 1475 94 Medical Management of Ectopic Pregnancy 1486 96 Alternatives to Hysterectomy in the Management of Leiomyomas 1493 99 Management of Abnormal Cervical Cytology and Histology 1507 *103 Hereditary Breast and Ovarian Cancer Syndrome (Joint with the Committee on Genetics and the Society of Gynecologic Oncologists) 1533 *104 Antibiotic Prophylaxis for Gynecologic Procedures 1543 *108 Polycystic Ovary Syndrome 1553 *109 Cervical Cytology Screening 1567 P OLICY S TATEMENTS AAFP—ACOG Joint Statement on Cooperative Practice and Hospital Privileges (July 1980, Revised and Retitled, March 1998) 1581 Abortion Policy (January 1993, Reaffirmed July 2007) 1583 Access to Women’s Health Care (July 1988, Reaffirmed July 2009) 1586 Certification and Procedural Credentialing (February 2008) 1587 Cervical Cancer Prevention in Low-Resource Settings (March 2004) 1589 Home Births in the United States (May 4, 2007) 1591 Joint Statement of ACOG/AAP on Human Immunodeficiency Virus Screening (May 1999, Reaffirmed July 2006) 1592 Joint Statement of Practice Relationships Between Obstetrician–Gynecologists and Certified Nurse-Midwives/Certified Midwives (October 2002) 1594 Midwifery Education and Certification (February 2006, Amended February 2007) 1595 The Role of Obstetrician-Gynecologists in Cosmetic Procedures (November 2008) 1596 Tobacco Marketing Aimed at Women and Adolescents (July 1990, Amended July 2009) 1597 A PPENDIX C ONTENTS F ROM O THER C OLLEGE R ESOURCES Guidelines for Perinatal Care, Sixth Edition 1601 Guidelines for Women’s Health Care, Third Edition 1603 Health Care For Adolescents 1604 Special Issues in Women’s Health 1604 Committee Opinions List of Titles 1605 Practice Bulletins List of Titles 1611 *Published in 2009
  • 11. Foreword The Compendium of Selected Publications CD-ROM is a compilation of all Committee Opinions, Practice Bulletins, Policy Statements, and Technology Assessments current as of December 31, 2009: • Committee Opinions: Brief focused documents that address clinical issues of an urgent or emergent nature or nonclinical topics such as policy, economics, and social issues that relate to obstetrics and gynecology. They are consensus statements that may or may not be based on scientific evidence. • Practice Bulletins: Evidence-based guidelines developed to indicate a preferred method of diagnosis and management of a condition. The evidence is graded, and peer-reviewed research determines the recommendations in the document. • Policy Statements: Position papers on key issues approved by the Executive Board. • Technology Assessments in Obstetrics and Gynecology: Documents that describe specific technolo- gies and their application. These series are developed by committees of experts and reviewed by leaders in the specialty and the College. Each document is reviewed periodically and either reaffirmed, replaced, or withdrawn to ensure its continued appropriateness to practice. The contribution of the many groups and individuals who participated in the process is gratefully acknowledged. Each section of the Compendium is devoted to a particular series, and includes those documents considered current at the time of publication. A comprehensive table of contents has been added for ease of use with titles listed numerically by committee. Those published within 2009 are indicated with an asterisk. Also provided are current Committee Opinion and Practice Bulletin lists of titles, grouped by committee in order of publication. As the practice of medicine evolves, so do College documents. As a part of the continuing process of review and revision, many documents initially published as a separate installment of a series evolve to become a part of a broader effort to educate and inform our Fellows. Books such Guidelines for Perinatal Care or Guidelines for Women’s Health Care carry equal weight as practice guidelines and should be considered adjuncts to the documents in the series. For ease of reference, the contents of these volumes are included in the appendix. The Compendium of Selected Publications CD-ROM and the companion 2010 Compendium of Selected Publications, which includes only 2008–2009 series documents current as of December 31, 2009, can be purchased by calling 800-762-2264 (Compendium CD-ROM only: $104, $59 [members]; 2010 Compendium and CD-ROM: $226, $99 [members]). Throughout the year, new documents will be published in the College’s official journal, Obstetrics & Gynecology. Single copies can be obtained from the Resource Center (202-863-2518), and the series are available for sale as complete sets or subscriptions (call 800-762-2264 to order). These documents also are available to members on our web site: www.acog.org. To verify the status of documents, contact the Resource Center or check our web site. We are making every effort to provide health professionals with current, quality information on the practice of obstetrics and gynecology. The Compendium of Selected Publications CD-ROM and the 2010 Compendium of Selected Publications represent still other ways to disseminate material designed to promote women’s health. —Ralph W. Hale, MD, Executive Vice President xi
  • 12. xii COMPENDIUM OF SELECTED PUBLICATIONS The Scope of Practice of Obstetrics and Gynecology Obstetrics and gynecology is a discipline dedicated to the broad, integrated medical and surgical care of women’s health throughout their lifespan. The combined discipline of obstetrics and gyne- cology requires extensive study and understanding of reproductive physiology, including the phys- iologic, social, cultural, environmental and genetic factors that influence disease in women. This study and understanding of the reproductive physiology of women gives obstetricians and gyne- cologists a unique perspective in addressing gender-specific health care issues. Preventive counseling and health education are essential and integral parts of the practice of obste- tricians and gynecologists as they advance the individual and community-based health of women of all ages. Obstetricians and gynecologists may choose a scope of practice ranging from primary ambulatory health care to concentration in a focused area of specialization. Approved by the Executive Board February 6, 2005
  • 13. Code of Professional Ethics of the American College of Obstetricians and Gynecologists Obstetrician-gynecologists, as members of the medical profession, have ethical responsibili- ties not only to patients, but also to society, to other health professionals and to themselves. The following ethical foundations for professional activities in the field of obstetrics and gynecology are the supporting structures for the Code of Conduct. The Code implements many of these foundations in the form of rules of ethical conduct. Certain documents of the American College of Obstetricians and Gynecologists also provide additional ethical rules, including documents addressing the following issues: seeking and giving consultation, informed consent, sexual misconduct, patient testing, human immunodeficiency virus, rela- tionships with industry, commercial enterprises in medical practice, and expert testimony. Noncompliance with the Code, including the above-referenced documents, may affect an individual’s initial or continuing Fellowship in the American College of Obstetricians and Gynecologists. These documents may be revised or replaced periodically, and Fellows should be knowledgeable about current information. Ethical Foundations I. The patient–physician relationship: The welfare of the patient (beneficence) is central to all considerations in the patient–physician relationship. Included in this relation- ship is the obligation of physicians to respect the rights of patients, colleagues, and other health professionals. The respect for the right of individual patients to make their own choices about their health care (autonomy) is fundamental. The principle of justice requires strict avoidance of discrimination on the basis of race, color, religion, national origin, or any other basis that would constitute illegal discrimination (justice). II. Physician conduct and practice: The obstetrician–gynecologist must deal honestly with patients and colleagues (veracity). This includes not misrepresenting himself or herself through any form of communication in an untruthful, misleading, or decep- tive manner. Furthermore, maintenance of medical competence through study, application, and enhancement of medical knowledge and skills is an obligation of practicing physicians. Any behavior that diminishes a physician’s capability to prac- tice, such as substance abuse, must be immediately addressed and rehabilitative services instituted. The physician should modify his or her practice until the dimin- ished capacity has been restored to an acceptable standard to avoid harm to patients 409 12th Street, SW (nonmaleficence). All physicians are obligated to respond to evidence of questionable PO Box 96920 conduct or unethical behavior by other physicians through appropriate procedures Washington, DC 20090-6920 established by the relevant organization. xiii
  • 14. xiv COMPENDIUM OF SELECTED PUBLICATIONS III. Avoiding conflicts of interest: Potential conflicts of interest are inherent in the practice of medicine. Physicians are expected to recognize such situations and deal with them through public disclosure. Conflicts of interest should be resolved in accordance with the best interest of the patient, respecting a woman’s autonomy to make health care decisions. The physician should be an advocate for the patient through public disclosure of conflicts of interest raised by health payer policies or hospital policies. IV. Professional relations: The obstetrician–gynecologist should respect and cooperate with other physicians, nurses, and health care professionals. V. Societal responsibilities: The obstetrician–gynecologist has a continuing responsibility to society as a whole and should support and participate in activities that enhance the community. As a member of soci- ety, the obstetrician–gynecologist should respect the laws of that society. As professionals and members of medical societies, physicians are required to uphold the dignity and honor of the profession. Code of Conduct I. Patient–Physician Relationship 1. The patient–physician relationship is the central focus of all ethical concerns, and the welfare of the patient must form the basis of all medical judgments. 2. The obstetrician–gynecologist should serve as the patient’s advocate and exercise all reasonable means to ensure that the most appropriate care is provided to the patient. 3. The patient–physician relationship has an ethical basis and is built on confidentiality, trust, and hon- esty. If no patient–physician relationship exists, a physician may refuse to provide care, except in emergencies. Once the patient–physician relationship exists, the obstetrician–gynecologist must adhere to all applicable legal or contractual constraints in dissolving the patient–physician relation- ship. 4. Sexual misconduct on the part of the obstetrician–gynecologist is an abuse of professional power and a violation of patient trust. Sexual contact or a romantic relationship between a physician and a cur- rent patient is always unethical. 5. The obstetrician–gynecologist has an obligation to obtain the informed consent of each patient. In obtaining informed consent for any course of medical or surgical treatment, the obstetrician–gyne- cologist must present to the patient, or to the person legally responsible for the patient, pertinent medical facts and recommendations consistent with good medical practice. Such information should be presented in reasonably understandable terms and include alternative modes of treatment and the objectives, risks, benefits, possible complications, and anticipated results of such treatment. 6. It is unethical to prescribe, provide, or seek compensation for therapies that are of no benefit to the patient. 7. The obstetrician–gynecologist must respect the rights and privacy of patients, colleagues, and others and safeguard patient information and confidences within the limits of the law. If during the process of providing information for consent it is known that results of a particular test or other information must be given to governmental authorities or other third parties, that must be explained to the patient. 8. The obstetrician–gynecologist must not discriminate against patients based on race, color, national origin, religion, or any other basis that would constitute illegal discrimination. II. Physician Conduct and Practice 1. The obstetrician–gynecologist should recognize the boundaries of his or her particular competencies and expertise and must provide only those services and use only those techniques for which he or she is qualified by education, training, and experience.
  • 15. CODE OF PROFESSIONAL ETHICS xv XV 2. The obstetrician–gynecologist should participate in continuing medical education activities to main- tain current scientific and professional knowledge relevant to the medical services he or she renders. The obstetrician–gynecologist should provide medical care involving new therapies or techniques only after undertaking appropriate training and study. 3. In emerging areas of medical treatment where recognized medical guidelines do not exist, the obste- trician–gynecologist should exercise careful judgment and take appropriate precautions to protect patient welfare. 4. The obstetrician–gynecologist must not publicize or represent himself or herself in any untruthful, misleading, or deceptive manner to patients, colleagues, other health care professionals, or the public. 5. The obstetrician–gynecologist who has reason to believe that he or she is infected with the human immunodeficiency virus (HIV) or other serious infectious agents that might be communicated to patients should voluntarily be tested for the protection of his or her patients. In making decisions about patient-care activities, a physician infected with such an agent should adhere to the fundamen- tal professional obligation to avoid harm to patients. 6. The obstetrician–gynecologist should not practice medicine while impaired by alcohol, drugs, or phys- ical or mental disability. The obstetrician–gynecologist who experiences substance abuse problems or who is physically or emotionally impaired should seek appropriate assistance to address these prob- lems and must limit his or her practice until the impairment no longer affects the quality of patient care. III. Conflicts of Interest 1. Potential conflicts of interest are inherent in the practice of medicine. Conflicts of interest should be resolved in accordance with the best interest of the patient, respecting a woman’s autonomy to make health care decisions. If there is an actual or potential conflict of interest that could be reasonably con- strued to affect significantly the patient’s care, the physician must disclose the conflict to the patient. The physician should seek consultation with colleagues or an institutional ethics committee to deter- mine whether there is an actual or potential conflict of interest and how to address it. 2. Commercial promotions of medical products and services may generate bias unrelated to product merit, creating or appearing to create inappropriate undue influence. The obstetrician–gynecologist should be aware of this potential conflict of interest and offer medical advice that is as accurate, bal- anced, complete, and devoid of bias as possible. 3. The obstetrician–gynecologist should prescribe drugs, devices, and other treatments solely on the basis of medical considerations and patient needs, regardless of any direct or indirect interests in or benefit from a pharmaceutical firm or other supplier. 4. When the obstetrician–gynecologist receives anything of substantial value, including royalties, from companies in the health care industry, such as a manufacturer of pharmaceuticals and medical devices, this fact should be disclosed to patients and colleagues when material. 5. Financial and administrative constraints may create disincentives to treatment otherwise recom- mended by the obstetrician–gynecologist. Any pertinent constraints should be disclosed to the patient. IV. Professional Relations 1. The obstetrician–gynecologist’s relationships with other physicians, nurses, and health care profes- sionals should reflect fairness, honesty, and integrity, sharing a mutual respect and concern for the patient. 2. The obstetrician–gynecologist should consult, refer, or cooperate with other physicians, health care professionals, and institutions to the extent necessary to serve the best interests of their patients.
  • 16. xvi COMPENDIUM OF SELECTED PUBLICATIONS V. Societal Responsibilities 1. The obstetrician–gynecologist should support and participate in those health care programs, prac- tices, and activities that contribute positively, in a meaningful and cost-effective way, to the welfare of individual patients, the health care system, or the public good. 2. The obstetrician–gynecologist should respect all laws, uphold the dignity and honor of the profes- sion, and accept the profession’s self-imposed discipline. The professional competence and conduct of obstetrician–gynecologists are best examined by professional associations, hospital peer-review committees, and state medical and licensing boards. These groups deserve the full participation and cooperation of the obstetrician–gynecologist. 3. The obstetrician–gynecologist should strive to address through the appropriate procedures the status of those physicians who demonstrate questionable competence, impairment, or unethical or illegal behav- ior. In addition, the obstetrician–gynecologist should cooperate with appropriate authorities to prevent the continuation of such behavior. 4. The obstetrician–gynecologist must not knowingly offer testimony that is false. The obstetrician–gynecologist must testify only on matters about which he or she has knowledge and experience. The obstetrician–gynecologist must not knowingly misrepresent his or her credentials. 5. The obstetrician–gynecologist testifying as an expert witness must have knowledge and experience about the range of the standard of care and the available scientific evidence for the condition in ques- tion during the relevant time and must respond accurately to questions about the range of the stan- dard of care and the available scientific evidence. 6. Before offering testimony, the obstetrician–gynecologist must thoroughly review the medical facts of the case and all available relevant information. 7. The obstetrician–gynecologist serving as an expert witness must accept neither disproportionate compensation nor compensation that is contingent upon the outcome of the litigation. Copyright © January 2008, The American College of Obstetricians and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington, DC 20090-6920. This document provides rules for ethical conduct for obstetricians and gynecologists.
  • 17. COMMITTEE OPINIONS COMMITTEE ON ADOLESCENT HEALTH CARE
  • 18. COMMITTEE OPINIONS COMMITTEE ON ADOLESCENT HEALTH CARE
  • 19. ACOG Committee Opinion Committee on Adolescent Health Care The Committee wishes to thank Abigail English, JD; S. Paige Number 302, October 2004 Hertweck, MD; Susan Kornetsky, MPH; Audrey Rogers, PhD, MPH; and John Santelli, MD, MPH for their assistance in the Guidelines for Adolescent Health development of this opinion. This document reflects emerging clini- Research cal and scientific advances as of the date issued and is subject to ABSTRACT: The risks of exposure to violence, human immunodeficiency change. The information should virus, and other sexually transmitted diseases; alcohol, tobacco, and pre- not be construed as dictating an scribed and illicit drug use; and unintended pregnancy, among others, threat- exclusive course of treatment or en the health and well-being of adolescents in the United States. Research is procedure to be followed. needed in these and other areas to improve adolescent health care and to aid Copyright © October 2004 in health policy decisions. Adolescents often are prevented from participating by the American College of in such research because of inadequate understanding of their legal status Obstetricians and Gynecologists. and the ethical considerations regarding their participation in research. All rights reserved. No part of There is confusion about what constitutes appropriate levels of protection for this publication may be repro- studies involving adolescents as research subjects and uncertainty about the duced, stored in a retrieval sys- need for parental permission. This document is designed to clarify the tem, or transmitted, in any form informed consent and parental permission issues as they pertain to adolescent or by any means, electronic, health research. mechanical, photocopying, recording, or otherwise, without prior written permission from the publisher. Background Requests for authorization to A basic criterion for ethical research is the protection of the rights and wel- make photocopies should be fare of people participating in research. The U.S. federal government has pro- directed to: mulgated regulations that govern research involving human subjects when the Copyright Clearance Center research is supported, conducted, or otherwise subject to regulation by the 222 Rosewood Drive federal government (1). These federal regulations on protection of human Danvers, MA 01923 (978) 750-8400 subjects in research, known as the Code of Federal Regulations: Title 45- Public Welfare; Part 46: Protection of Human Subjects (45 CFR Part 46), pro- ISSN 1074-861X vide for a nationwide system of local Institutional Review Boards (IRBs). The American College of These IRBs must review and approve all federally funded research involving Obstetricians and Gynecologists human subjects and are regulated by the Office for Human Research 409 12th Street, SW Protections in the Department of Health and Human Services. Most universi- PO Box 96920 Washington, DC 20090-6920 ties and research institutions apply these regulations to privately funded research as well. These regulations serve as guidelines for IRB review and approval. They require that risks to research participants are minimized and Guidelines for adolescent health that they are reasonable relative to the anticipated benefits and the importance research. ACOG Committee Opinion No. 302. American College of of the knowledge that may be expected to result from the research. The reg- Obstetricians and Gynecologists. ulations also require that the selection of research participants is equitable and Obstet Gynecol 2004;104:899–902. that informed consent is provided from each prospective research participant 3
  • 20. 4 COMPENDIUM OF SELECTED PUBLICATIONS or the participant’s legally authorized representative. minor can begin to consent (6). Researchers in ado- Informed consent is the ability to understand the lescent health should be familiar with current state risks and benefits of one’s participation in a research statutes regarding age of majority and emancipation, activity and to authorize one’s participation in this as well as with minor consent statutes. An up-to-date activity freely (2). General requirements for in- listing of these statutes can be found online at formed consent are described in 45 CFR Part 46, http://www.guttmacher.org/pubs/spib.html. Section 116 (1). Finally, the regulations require that the research plan makes adequate provisions for ensuring the safety of research participants and that Regulations adequate provisions are made to protect the privacy In the federal regulations governing research, chil- of research participants and to maintain the confiden- dren are defined in 45 CFR 46 Section 102(a) as tiality of data. Subpart D of 45 CFR Part 46 contains “persons who have not attained the legal age for special protections for children who participate as consent to treatments or procedures involved in the subjects in research. research, under the applicable law of the jurisdiction Research involving adolescents, especially in which the research will be conducted”(1). This regarding behaviors related to sexuality, often raises definition refers to laws, primarily state laws related questions about how to obtain adequate informed to consent for treatment of minors, age of majority, consent and protection of the research participants’ and emancipation status. confidential receipt of health care services. The Federal regulations governing human subject Society for Adolescent Medicine provided early research require parental permission and child leadership to address these concerns. In 1995, they assent for subjects who meet the regulatory defini- led the development of consensus guidelines to pro- tion of “children,” ie, those who are younger than the mote the ethical conduct of health research involv- state-mandated age at which people may give legal- ing adolescents as research participants (3). The ly effective informed consent for treatments or pro- society recently issued a revised position statement cedures involved in the research. Assent means a to support the guidelines (4); the Society for child has given affirmative agreement to participate Adolescent medicine also established a code of in research. Mere failure to object should not, absent research ethics to encourage, enhance, and promote affirmative agreement, be construed as assent. ethical standards for the conduct of research in ado- Assent is required when, in the judgment of the IRB, lescent health (5). the children are capable of providing it (1).The fed- When considering the legal complexities of ado- eral regulations deliberately use the terms “permis- lescent health research, it is important to recognize sion” and “assent” to differentiate this process from that the age of majority in almost every state is 18 the usual informed consent process. An individual years, and all states recognize the concept of eman- can provide consent only for himself or herself. cipated minors, who generally are allowed to consent Therefore, parents give only permission for their for their own health care. In addition, every state has child to be involved in research, not consent. Assent enacted some minor consent laws that allow minors recognizes the importance of the emerging capacity to consent for their own health care, whether or not of children to give informed consent for themselves, they are legally emancipated. Such laws may be as well as the ethical importance of obtaining their based on the status of the minor or the services they agreement to participate even if they are not legally are seeking. Minors who may consent for their own authorized to give informed consent. health care based on their status include those who In 1977, the National Commission for the are married, are members of the armed forces, live Protection of Human Subjects of Biomedical and apart from their parents, and are parents of a child. In Behavioral Research recommended that individual addition, all states allow adolescents who are minors IRBs be allowed to determine that parental permis- to consent for some categories of health care such as sion is not appropriate in certain research studies, sexually transmitted disease (STD) services (all including research involving assessment for or care states), drug and alcohol care (almost all states), con- related to contraception and drug abuse (7). traceptive services and pregnancy related care (a According to the federal regulations (1), informed majority of states), outpatient mental health counsel- consent may be waived under 45 CFR Part 46 ing (about one half of states), or sexual assault care Section 116(d) and parental permission may be (a few states). Some states specify the age at which a waived under 45 CFR Part 46 Section 408(c).
  • 21. COMMITTEE OPINIONS 5 Four criteria set forth by 45 CFR Part 46 116(d) adolescents. It is important to note that if these sur- allow an IRB to waive the requirement to obtain the veys are conducted in a school setting, federal edu- informed consent for adult research subjects or per- cational law governing certain research conducted in mission of a parent or guardian for research subjects schools may apply. Health researchers working in who are children if: 1) the research involves no more schools are, therefore, advised to become knowl- than “minimal risk” (which means that the probabil- edgeable about these laws. ity and magnitude of harm or discomfort anticipated Section 408(c) of 45 CFR Part 46 also may be in the research are not greater in and of themselves used to waive parental permission for research areas than those ordinarily encountered in daily life or including STDs, birth control usage, high-risk during the performance of routine physical or psy- behaviors, HIV prevention, and situations in which chologic examinations or tests [1]), 2) the waiver obtaining parental consent may be dangerous to the will not adversely affect the rights and welfare of the child (abuse situations). Finally, in certain research subjects, 3) the research could not practically be car- studies, adolescent minors would not be considered ried out without a waiver, and 4) whenever appropri- children and parental permission would not be ate, the subjects will be provided with additional required. Such research includes certain clinical pertinent information after participation (1). This studies involving pregnancy, family planning, and section is commonly used when waiving informed treatment of STDs where the adolescent minor can consent for research involving existing data such as legally consent to such services. Again, familiarity medical records. with current state statutes on the rights of minors to In addition, 45 CFR Part 46 Section 408(c) consent to health care services is essential. specifically allows for a waiver of parental permis- Researchers conducting and IRBs reviewing sion under Subpart D, which addresses research with research involving adolescents should be knowl- children. Section 408(c) of 45 CFR Part 46 states: edgeable of the federal regulations and the ethical “…if an IRB determines that a research protocol is principles that underlie these regulations. They designed for conditions or a subject population for should understand when parental permission is which parental permission is not a reasonable required and when it may be waived. Personal requirement to protect subjects (eg, neglected or beliefs and attitudes should not enter into this deci- abused children), it may waive consent requirements sion. The Society for Adolescent Medicine’s provided an appropriate mechanism for protecting Guidelines for Adolescent Health Research (4) pro- the children who will participate as research subjects vide a comprehensive approach to understanding is substituted and provided the waiver is not incon- these issues. Parental permission should not be a sistent with federal, state, or local law…. The choice barrier to the inclusion of adolescents in studies that of an appropriate mechanism would depend on the meet federal regulations and are designed to nature and purpose of the activities described in the improve their health. protocol, the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition” (1). In discussing the waiver of parental Conclusions permission, the National Commission cited as exam- ples of when the requirement might not be a reason- 1. Researchers developing study protocols and able one: “…[r]esearch designed to identify factors materials for submission for IRB review and related to the incidence or treatment of certain con- approval and the IRBs themselves should be ditions in adolescents for which, in certain jurisdic- familiar with, and adhere to, current federal reg- tions, they legally may receive treatment without ulations, 45 CFR Part 46 (1), and federal and parental consent; [and] research in which the sub- state laws that affect research (including laws jects are ‘mature minors’ and the procedures regarding age of majority and emancipation, involved entail essentially no more than minimal minor consent statutes, and federal educational risk that such individuals might reasonably assume law governing certain research conducted in on their own…” (7). schools). Based on these criteria, either 45 CFR Part 46 2. Investigators will communicate better with IRB Section 408(c) or 45 CFR Part 46 Section 116(d) panels regarding the involvement of adolescent may be used to waive parental permission in a vari- participants in research if they understand the ety of studies, including, for example, surveys of purpose of human subject protection regulations
  • 22. 6 COMPENDIUM OF SELECTED PUBLICATIONS with respect to minors and review the guidelines 2. American College of Obstetricians and Gynecologists. provided by the Society for Adolescent Ethics in obstetrics and gynecology. 2nd ed. ACOG: Washington, DC; 2004. Medicine (3–5). 3. Guidelines for adolescent health research. 1995. Society 3. Under the following circumstances it is reason- for Adolescent Medicine. J Adolesc Health 2003;33: able to waive parental permission when adoles- 410–5. cents are involved in studies: a) the waiver 4. Santelli JS, Smith Rogers A, Rosenfeld WD, DuRant RH, Dubler N, Morreale M, et al. Guidelines for adolescent would not adversely affect the rights and wel- health research: A position paper of the Society for fare of the adolescent, b) the study poses no Adolescent Medicine. J Adolesc Health 2003;33: more than a minimal risk to adolescents, c) the 396–409. study could not be practically carried out with- 5. Code of Research Ethics: position paper of the Society for out a waiver, and d) requiring permission may Adolescent Medicine. J Adolesc Health 1999;24:277–82; discussion 283. not be reasonable to protect subjects. Parental 6. English A, Kenney KE. State minor consent laws: a sum- permission is not a requirement for research mary. 2nd Ed. Chapel Hill (NC): Center for Adolescent involving the provision of health care for which Health & the Law; 2003. adolescents do not legally need parental con- 7. The National Commission for the Protection of Human sent. It is important to review 45 CFR Part 46 Subjects of Biomedical and Behavioral Research. Research involving children: report and recommenda- for the necessary details. tions. Bethesda (MD): U.S. Department of Health Educa- tion and Welfare; 1977. References 1. Protection of human subjects. 45 C.F.R §46 (2003). Avail- able at http://www.access.gpo.gov/nara/cfr/cfr-tablesearch. html#page1. Retrieved July 8, 2004.
  • 23. COMMITTEE OPINIONS 7 ACOG Committee Opinion ACOG Committee on Adolescent Health Care This document reflects emerging clinical and scientific advances as of the date issued and is subject Number 310, April 2005 to change. The information should not be construed as dictat- ing an exclusive course of treat- ment or procedure to be followed. Endometriosis in Adolescents The Committee wishes to thank ABSTRACT: Historically thought of as a disease that affects adult women, Marc R. Laufer, MD; Joseph endometriosis increasingly is being diagnosed in the adolescent population. Sanfilippo, MD; and Jonathon This disorder, which was originally described more than a century ago, still Solnik, MD; for their assistance represents a vague and perplexing entity that frequently results in chronic in the development of this docu- pelvic pain, adhesive disease, and infertility. The purpose of this Committee ment. Opinion is to highlight the differences in adolescent and adult types of endometriosis. Early diagnosis and treatment during adolescence may decrease Copyright © April 2005 disease progression and prevent subsequent infertility. by the American College of Obstetricians and Gynecologists. All rights reserved. No part of this publication may be repro- Incidence duced, stored in a retrieval sys- tem, or transmitted, in any form It has been difficult to establish accurate prevalence rates of endometriosis in or by any means, electronic, adult and adolescent women. Documented rates in adolescent patients under- mechanical, photocopying, going laparoscopy for chronic pelvic pain range from 19% to 73%. Goldstein recording, or otherwise, without et al (1) reported a 47% prevalence of endometriosis found at laparoscopy in prior written permission from the publisher. a prospective study of adolescent females with pelvic pain. Other studies have shown that 25–38% of adolescents with chronic pelvic pain have endometrio- Requests for authorization to sis (2, 3). In addition, it has been shown that 50–70% of adolescents with make photocopies should be directed to: pelvic pain not responding to combination hormone therapy (such as oral contraceptive pills [OCPs]) and nonsteroidal antiinflammatory drugs Copyright Clearance Center (NSAIDs) have endometriosis at the time of laparoscopy (4, 5). 222 Rosewood Drive Danvers, MA 01923 Endometriosis also has been identified in premenarcheal girls who have (978) 750-8400 started puberty and have some breast development (6, 7). The occurrence of endometriosis before menarche contributes to the argument that one etiology ISSN 1074-861X for endometriosis lies in the theory of embryonic müllerian rests or coe- The American College of lomic metaplasia as opposed to retrograde menses. Based on the occurrence Obstetricians and Gynecologists of early endometriosis, some authors have argued that “thelarche be recog- 409 12th Street, SW PO Box 96920 nized as a developmental benchmark, after which endometriosis is included Washington, DC 20090-6920 in the differential diagnosis of chronic pelvic pain” (6). It is common for adult women who have endometriosis to bring in their adolescent daughters for evaluation and early diagnosis. Data from the Endometriosis in adolescents. ACOG Endometriosis Association indicate that 66% of adult women reported the Committee Opinion No. 310. American College of Obstetricians onset of pelvic symptoms before age 20 years. Forty-seven percent of these and Gynecologists. Obstet Gynecol women reported they had to see a doctor five times or more before receiving 2005;105:921–7. the diagnosis of endometriosis or referral. As the age of the onset of symp-
  • 24. 8 COMPENDIUM OF SELECTED PUBLICATIONS toms decreases, the number of doctors having to be When evaluating an adolescent for suspected seen to reach a diagnosis increases. Specifically, an endometriosis or dysmenorrhea, the clinician should average of 4.2 doctors were seen for patients whose aim to rule out a pelvic mass or a congenital anom- symptoms began before age 15 years compared with aly of the reproductive tract. A bimanual examina- an average of 2.64 doctors for patients whose symp- tion may not be necessary to evaluate pelvic pain, toms began between the ages of 30 years and 34 especially in adolescents who are virgins. If a bi- years. There are, on average, 9.28 years from the manual examination cannot be performed or is onset of symptoms to the diagnosis (8). Endome- declined, a rectal–abdominal examination in the dor- triosis is believed to be a progressive disease be- sal lithotomy position may be helpful to determine if cause the prevalence and severity of the stage of the a pelvic mass is present, and a cotton-tipped swab disease significantly increase with age (9, 10). With can be inserted into the vagina to evaluate for the early diagnosis and treatment, it is hoped that dis- presence of a transverse vaginal septum, vaginal ease progression and infertility can be limited, but agenesis, or agenesis of the lower vagina. If a biman- this remains to be proved with prospective research. ual examination is performed, the clinician should check for the existence of both diffuse and focal pelvic tenderness, and evaluate the pelvis for a dis- Presentation and Characteristics placed uterus or an adnexal mass. An ultrasound The typical presentation of an adolescent with examination may be helpful in evaluating the pelvis endometriosis may be different from that of an adult. of a young adolescent who declines a bimanual or One significant difference is that adolescents pri- rectal–abdominal examination. marily seek medical attention because of pain rather than a concern for infertility. The most common Imaging Studies and Serum Markers symptom noted among published reviews is Ultrasonography and magnetic resonance imaging acquired or progressive dysmenorrhea, which was are helpful in evaluating anatomical structures, but encountered in 64–94% of patients (4, 11). Other are not specific for diagnosing endometriosis. An common symptoms included acyclic pain (36–91%), adolescent will rarely have a pelvic mass from an dyspareunia (14–25%), and gastrointestinal com- endometrioma or uterosacral nodularity. CA 125, plaints (2–46%) (11). Adolescents found to have although very sensitive, is not specific and, thus, is endometriosis most commonly present with both not helpful in the diagnosis of adolescent endo- cyclic and acyclic pain (62.6%), as opposed to metriosis. No data exist regarding the use of CA 125 acyclic pain alone (28.1%), or cyclic pain alone to monitor the clinical progression or regression of (9.4%) (11). disease in adolescents with endometriosis. In young women, pelvic pain associated with endometriosis often interferes with school atten- Empiric Therapy dance as well as physical and social activities. Prompt diagnosis and adequate therapy, therefore, If an adolescent younger than 18 years has persistent may return normal psychosocial development and pain while taking combination hormone therapy and self-esteem, improve scholastic performance, and NSAIDs, endometriosis should be suspected and she lead to a return to normal daily activities. should be offered a laparoscopic evaluation (discus- sion follows in section on “Surgical Diagnosis”). If, however, she is older than 18 years and had a nega- Diagnosis tive assessment for an ovarian mass or tumor, she can be offered an empiric trial of gonadotropin- History and Physical Examination releasing hormone (GnRH) agonist therapy (12, 13). A thorough review of history and physical examina- If the pain subsides with the use of GnRH agonist, tion are necessary to assess a variety of differential then a diagnosis of endometriosis can be made. An diagnoses of pelvic pain such as appendicitis, pelvic empiric trial of GnRH agonist is not routinely inflammatory disease, müllerian anomalies or out- offered to patients younger than 18 years because flow obstruction, bowel disease, hernias, musculo– the effects of these medications on bone formation skeletal disorders, and psychosocial complaints. and long-term bone density have not been ade- Pelvic examination may be difficult, especially in quately studied. For patients younger than 18 years patients who have not had vaginal intercourse. or who decline empiric therapy, diagnostic and ther-
  • 25. COMMITTEE OPINIONS 9 apeutic laparoscopy can be initiated. An algorithm ommended for diagnosing and treating presumed for therapy is provided in Figure 1 (14). endometriosis in an adolescent. Laparoscopy can be safely performed in adolescents. At the time of sur- Surgical Diagnosis gical diagnosis, most adolescents have Stage I dis- After a comprehensive preoperative evaluation and ease as classified by the American Society for trial of combination hormone therapy and NSAIDs Reproductive Medicine classification system (15). to treat dysmenorrhea, laparoscopy should be rec- Goldstein et al commented that almost 60% of the History Physical examination Consider radiologic imaging Pain diary Cyclic CHT and NSAIDs If persistent pain Empiric GnRH agonist (if older than 18 years) If improved—diagnosis is endometriosis Laparoscopy Diagnosis of endometriosis by visualization or biopsy Surgical treatment (ablation/resection/laser) of endometriosis Endometriosis identified visually or by pathology No endometriosis—visually and histologically negative <16 years >16 years Continuous CHT GnRH agonist Gastrointestinal or urologic evaluation Symptoms persist (± add-back)* Pain management service OR Continuous CHT Continuous CHT No pain Continued pain Continue CHT Laparoscopy with resection of endometriosis and/or Long-term GnRH agonist with add-back and Pain management service Complementary or alternative therapies Abbreviations: NSAIDs, nonsteroidal antiinflammatory drugs; CHT, combination hormone therapy (oral contraceptive pills, estrogen/progestin patch, estrogen/progestin vaginal ring, norethindrone acetate, medroxyprogesterone acetate); GnRH, gonadotropin-releasing hormone. *Add-back indicates use of estrogen and progestin or norethindrone acetate alone. Fig. 1. Protocol for evaluation and treatment of adolescent pelvic pain and endometriosis. (Modified with permission from Bandera CA, Brown LR, Laufer MR. Adolescents and endometriosis. Clin Consult Obstet Gynecol 1995;7:206.)
  • 26. 10 COMPENDIUM OF SELECTED PUBLICATIONS patients in their cohort had Stage I disease (1), of endometriosis. The goal of therapy for adolescent whereas 80% of the cases reported by other endometriosis should be suppression of pain, sup- researchers had minimal to mild disease (4). pression of disease progression, and preservation of Gynecologic surgeons who perform laparoscopy in fertility. Consequently, after surgery, all adolescents adolescents with pelvic pain should be familiar with who have endometriosis should be treated with med- the typical lesions of endometriosis in adolescents, ical therapy until they have completed child bearing which tend to be red, clear, or white (15) as opposed to suppress pain, progression of disease, and result- to the powder-burn lesions seen commonly in adults ing potential infertility. who have endometriosis. The use of a liquid medium First-line treatment modalities should involve in the pelvis may facilitate the identification of clear the use of NSAIDs and hormone therapy. Because lesions, which are very common in adolescents (11). red lesions have been shown to be active producers of prostaglandins, and adolescents with endometrio- Müllerian Anomalies and Endometriosis sis typically report severe dysmenorrhea, NSAIDs The development of endometriosis in adolescent may be used in conjunction with hormonal men- patients has been associated with müllerian anom- strual suppressive therapy to provide sufficient alies with outflow tract obstruction. The published relief. Most pharmacologic agents bring about relief incidence of anomalies of the reproductive system by inducing an anovulatory or a hypoestrogenic and associated endometriosis has been reported to state or both. Continuous combination hormone be as high as 40%, but most studies quote a rate of therapy (OCPs, combination hormonal contracep- 5–6%. The clinical outcome in patients with outflow tive patch, or vaginal ring) for menstrual suppression tract obstructions has been reported to differ from can be used to create a “pseudopregnancy” state, those without such obstruction because regression of which was described more than 40 years ago (17). disease usually has been observed once surgical cor- This method routinely has been promoted for ado- rection of the anomaly has been accomplished (16). lescents who have endometriosis. Although this method may provide effective relief, the Cochrane Database Review 2003 provided data suggesting Treatment that further studies are needed to prove long-term The premise for treating the symptomatic adolescent benefits (18). Most clinicians advocate continuous is based on the concept that endometriosis has been use of combination hormone therapy to induce shown to be a progressive disease without a known amenorrhea, but this modality can result in signifi- cure. A physician treating an adolescent with endo- cant breakthrough bleeding. One randomized con- metriosis should adopt a multidimensional approach trolled trial compared a 28-day regimen with contin- and consider the use of the following components: uous combination oral contraceptives and found no surgery, hormonal manipulation, pain medications, increase in spotting days after 9 months of therapy, mental health support, complementary and alterna- with fewer total bleeding days in the group taking tive therapies, and education. continuous combination oral contraceptives (19). Patients younger than 18 years with persistent Thus, continuous use of combination hormone ther- pelvic pain while taking combination hormone ther- apy is believed to be both safe and effective for ado- apy should routinely be offered a laparoscopic pro- lescents with endometriosis-related pain and, thus, is cedure for diagnosis and surgical management of the first-line hormone therapy for adolescents endometriosis. The gynecologic surgeon must be younger than 16 years with endometriosis. Gonado- familiar with the appearance of endometriosis in tropin-releasing hormone agonists are not offered as adolescents and should remove or destroy all visi- first-line therapy for adolescents in this age range. ble lesions of endometriosis. Only procedures that Progestin-only protocols have been used for the preserve fertility options should be applied; oophor- treatment of adult endometriosis with mixed results. ectomy or hysterectomy should not be offered to In a recent critical review, progestins were shown to adolescents. be as effective as danazol or GnRH agonists (20). Long-term follow-up studies of treatments for Common side effects include irregular bleeding and adolescent endometriosis have not been performed. weight gain. Some studies suggest that these side Current treatments for adolescents have been extrap- effects are well tolerated (20), however in a data set olated and adapted from the literature of adult cases of 3,751 women who have endometriosis, treatment
  • 27. COMMITTEE OPINIONS 11 with medroxyprogesterone acetate or depot medroxy- progesterone acetate (0.625/2.5 mg per day) can progesterone acetate was the least well tolerated and help preserve bone density (26, 27). Add-back ther- was the least effective in treating pain compared apy has been shown not to influence the primary with combination OCPs, GnRH agonists, and pain therapeutic effect and resulted in less bone loss medications (8). Furthermore, depot medroxyprog- 12 months after cessation of therapy in adult esterone acetate used for longer than 2 years has women. There is some evidence in adults to suggest been shown to decrease bone density in adolescents that immediate add-back therapy may result in even (21, 22, 23). The U.S. Food and Drug Administra- less bone loss (28). No data exist on the long-term tion has warned against the long-term use of depot effects of GnRH agonist use with add-back therapy medroxyprogesterone acetate because of adverse in the adolescent population and, thus, it should be affects on bone density (24). reserved for adolescents refractory to continuous Danazol, an androgenic and antiestrogenic combination hormone therapy (14, 29). Lifestyle agent, is extremely effective in treating symptomatic modifications, such as adequate physical exercise endometriosis in adults. Doses of 400–800 mg daily and calcium and vitamin D intake, also are essential have been advocated for 6 months followed by con- to maintaining proper bone health when taking tinuous OCP use for maintenance suppression of the GnRH agonists (with or without add-back therapy). hypothalamic–pituitary ovarian axis. This choice of Aside from medical management, surgery also pharmacotherapy was more common in the 1980s, has proved to be an effective form of treatment for but the androgenic side effects have made this a poor adult patients with pain (30). Surgery for the man- option for adolescents. agement of endometriosis-related pain is an impor- Gonadotropin-releasing hormone agonists cre- tant option for adolescents, but clearly, radical ate a hypoestrogenic state by downregulating the procedures (oophorectomy, bilateral oophorectomy, hypothalamic–pituitary axis. Whereas these agents or hysterectomy) should be avoided in this age are greatly effective in the treatment of endometrio- group, even in rare cases of severe endometriosis. A sis-related pain in adolescents, their use alone (with- double-blinded randomized controlled trial com- out add-back therapy described in the following pared laser vaporization of endometriosis and laser paragraph) usually is limited to 6 months because of uterosacral nerve ablation with controls in 63 adult the resultant profound hypoestrogenic state and its patients with proven endometriosis. At 6 months of subsequent effect on bone mineralization. This is a follow-up, 63% of patients reported significant relief major issue for an adolescent who is accruing peak compared with 23% of controls (31). Patients with bone mineral density. Therefore, it has been suggest- more advanced disease had better outcomes in pain ed that this therapy not be offered as a first-line treat- management compared with those with minimal dis- ment for adolescents younger than 16 years (14). At ease. At 1-year follow-up, 90% of those in the treat- 6 months, GnRH agonist induces a 5% loss in tra- ment arm who initially responded had continued becular bone mineral density and a 2% loss in pain relief (32). Among the symptomatic controls, femoral neck bone mineral density in adult women. an even distribution of patients was noted to have In a cross-sectional study, researchers collected bone progression, regression, and maintenance of disease. mineral density test results of 265 females, aged Both new and recurrent disease was noted at second 8–50 years (25). They determined that the majority look. In a Cochrane review of these data, adult of bone mass growth is achieved by age 20 years and patients were almost 5 times more likely to benefit that after the age 18 years, no significant differences from surgical management of endometriosis com- in bone mass or bone mineral density were noted at pared with controls (33). One study demonstrated, in most skeletal sites. This emphasizes that a drug- a prospective review of 643 patients with pain, or induced hypoestrogenic state could significantly infertility, or both, that there was a significant rela- affect peak bone mineralization that occurs during tionship between pain and the depth of infiltration of adolescence, particularly in females younger than 16 the endometriosis implants (9). This study also con- years. firmed that red implants were more common in Investigators have determined that to reduce the younger patients and that the depth of invasion symptoms and bone loss related to a hypoestrogenic increased with age, suggesting that endometriosis is state, add-back therapy with norethindrone acetate a progressive disease. The concept that endometrio- (5 mg per day) or conjugated estrogens/medroxy- sis is a progressive disease supports the recommen-