1. The document discusses extended cycle oral contraceptives that provide contraception for 84 days by suppressing ovulation through a combination of ethinyl estradiol and levonorgestrel, followed by 7 days of placebo or low-dose estrogen pills.
2. Clinical trials showed that extended cycle pills were as effective at preventing pregnancy as conventional 28-day pills, with similar safety profiles. Adverse effects were mild and consistent with other combined oral contraceptives.
3. The extended cycle regimen was found to be over 99% effective at preventing pregnancy when taken correctly, and resulted in less frequent bleeding and spotting compared to a 28-day regimen.
Introduction: Though there are many studies on the effects of anesthesia methods used for cesarean section on the newborn,
research on this topic still continues. In our prospective observational study, we investigated the effects of different anesthesia techniques used in routine cesarean deliveries on early neonatal outcomes in our hospital. This prospective, observational, randomized study included a total of 222 ASA II risk group pregnant women undergoing elective cesarean section at term (38-41 weeks’ gestation) without fetal distress. The women were randomized into three groups. In the general anesthesia with propofol group (Group P, n = 74), anesthesia was induced with 2 mg∙kg-1 propofol and 0.6-0.9 mg∙kg-1
rocuronium. In the general anesthesia with thiopental sodium group (Group T, n = 74), anesthesia was induced with 5 mg∙kg-1 thiopental sodium and 0.6-0.9 mg∙kg-1 rocuronium. Women in the spinal anesthesia group (Group SA, n = 74) were administered 0.5% (10 mg) hypertonic bupivacaine and 10 mcg fentanyl.
IOSR Journal of Pharmacy and Biological Sciences(IOSR-JPBS) is an open access international journal that provides rapid publication (within a month) of articles in all areas of Pharmacy and Biological Science. The journal welcomes publications of high quality papers on theoretical developments and practical applications in Pharmacy and Biological Science. Original research papers, state-of-the-art reviews, and high quality technical notes are invited for publications.
The document provides guidelines for writing an evidence-based review article. It defines different types of review articles and outlines the key steps, which include: selecting a topic of clinical relevance; conducting a comprehensive literature search of sources like systematic reviews and clinical practice guidelines; evaluating the strength and validity of the evidence; and presenting the information in a standardized format covering introduction, methods, discussion, and references. The discussion section should provide an evidence-based analysis of a topic, acknowledge any controversies, and rate the level of evidence for key statements and recommendations.
Methods: The current case-control study was conducted at Ain Shams University Maternity Hospital. The study included two groups of women: group A, including pregnant women with a history of unexplained recurrent miscarriage; and group B, including control pregnant women with no prior miscarriage. Women included in either group were at their first trimester of pregnancy (6-13 weeks of gestation). For all included women, 3-hour oral glucose test was performed. Serum insulin levels were measured at the same times. Markers of insulin resistance, including HOMA-IR, HOMA-B, AUCG and AUCI were calculated.
This research article examines alterations in reproductive hormones during pregnancy and the risk of preeclampsia. The study followed 79 preeclamptic women and 80 healthy pregnant controls longitudinally from the third trimester through 6 weeks postpartum. Blood samples were taken at each visit and analyzed for beta-hCG, oestriol, progesterone and prolactin levels. Results showed beta-hCG and oestriol levels were significantly altered in the preeclamptic group compared to controls in the first and third trimesters respectively, indicating these hormones may help identify risk of preeclampsia earlier in pregnancy. The study aims to determine the gestational age at which hormonal changes occur that are associated with developing preecl
This literature review investigated restrictions on oral intake during labour. It found no evidence that restricting intake improves maternal or neonatal outcomes when the mother is low risk. While earlier concerns about aspiration prompted restrictions, modern techniques have made aspiration extremely rare. The evidence suggests low-risk women who wish to eat or drink lightly in labour should not be prevented from doing so.
Obstetric outcomes associated with second trimester unexplained abnormal mate...Apollo Hospitals
1) To compare the adverse obstetrical outcomes in the patient population with normal blood MoMs.
2) To determine the probability of occurrence of an adverse obstetric event in relation with abnormal maternal blood
analytes.
This study examined caesarean section (CS) rates in women with gestational diabetes (GDM) using the Robson criteria for classification. The study found that the overall CS rate was 32.5% for women with GDM, compared to 19.6% for the general population. Nulliparous women with GDM undergoing induction of labor had the highest CS rates, at 63% for nulliparous women and 20% for multiparous women. The majority (71%) of women with a previous CS delivered by repeat CS. The results support thoughtful induction of labor in GDM patients and counseling women on possible outcomes of induction.
Introduction: Though there are many studies on the effects of anesthesia methods used for cesarean section on the newborn,
research on this topic still continues. In our prospective observational study, we investigated the effects of different anesthesia techniques used in routine cesarean deliveries on early neonatal outcomes in our hospital. This prospective, observational, randomized study included a total of 222 ASA II risk group pregnant women undergoing elective cesarean section at term (38-41 weeks’ gestation) without fetal distress. The women were randomized into three groups. In the general anesthesia with propofol group (Group P, n = 74), anesthesia was induced with 2 mg∙kg-1 propofol and 0.6-0.9 mg∙kg-1
rocuronium. In the general anesthesia with thiopental sodium group (Group T, n = 74), anesthesia was induced with 5 mg∙kg-1 thiopental sodium and 0.6-0.9 mg∙kg-1 rocuronium. Women in the spinal anesthesia group (Group SA, n = 74) were administered 0.5% (10 mg) hypertonic bupivacaine and 10 mcg fentanyl.
IOSR Journal of Pharmacy and Biological Sciences(IOSR-JPBS) is an open access international journal that provides rapid publication (within a month) of articles in all areas of Pharmacy and Biological Science. The journal welcomes publications of high quality papers on theoretical developments and practical applications in Pharmacy and Biological Science. Original research papers, state-of-the-art reviews, and high quality technical notes are invited for publications.
The document provides guidelines for writing an evidence-based review article. It defines different types of review articles and outlines the key steps, which include: selecting a topic of clinical relevance; conducting a comprehensive literature search of sources like systematic reviews and clinical practice guidelines; evaluating the strength and validity of the evidence; and presenting the information in a standardized format covering introduction, methods, discussion, and references. The discussion section should provide an evidence-based analysis of a topic, acknowledge any controversies, and rate the level of evidence for key statements and recommendations.
Methods: The current case-control study was conducted at Ain Shams University Maternity Hospital. The study included two groups of women: group A, including pregnant women with a history of unexplained recurrent miscarriage; and group B, including control pregnant women with no prior miscarriage. Women included in either group were at their first trimester of pregnancy (6-13 weeks of gestation). For all included women, 3-hour oral glucose test was performed. Serum insulin levels were measured at the same times. Markers of insulin resistance, including HOMA-IR, HOMA-B, AUCG and AUCI were calculated.
This research article examines alterations in reproductive hormones during pregnancy and the risk of preeclampsia. The study followed 79 preeclamptic women and 80 healthy pregnant controls longitudinally from the third trimester through 6 weeks postpartum. Blood samples were taken at each visit and analyzed for beta-hCG, oestriol, progesterone and prolactin levels. Results showed beta-hCG and oestriol levels were significantly altered in the preeclamptic group compared to controls in the first and third trimesters respectively, indicating these hormones may help identify risk of preeclampsia earlier in pregnancy. The study aims to determine the gestational age at which hormonal changes occur that are associated with developing preecl
This literature review investigated restrictions on oral intake during labour. It found no evidence that restricting intake improves maternal or neonatal outcomes when the mother is low risk. While earlier concerns about aspiration prompted restrictions, modern techniques have made aspiration extremely rare. The evidence suggests low-risk women who wish to eat or drink lightly in labour should not be prevented from doing so.
Obstetric outcomes associated with second trimester unexplained abnormal mate...Apollo Hospitals
1) To compare the adverse obstetrical outcomes in the patient population with normal blood MoMs.
2) To determine the probability of occurrence of an adverse obstetric event in relation with abnormal maternal blood
analytes.
This study examined caesarean section (CS) rates in women with gestational diabetes (GDM) using the Robson criteria for classification. The study found that the overall CS rate was 32.5% for women with GDM, compared to 19.6% for the general population. Nulliparous women with GDM undergoing induction of labor had the highest CS rates, at 63% for nulliparous women and 20% for multiparous women. The majority (71%) of women with a previous CS delivered by repeat CS. The results support thoughtful induction of labor in GDM patients and counseling women on possible outcomes of induction.
1. The document provides information on the emergency contraceptive ulipristal acetate (UPA), including its mechanism of action, pharmacokinetics, clinical evaluations in randomized studies, contraindications, precautions, adverse reactions and drug interactions.
2. Key points include that UPA prevents pregnancy by inhibiting or delaying ovulation and altering the endometrium; clinical trials found it to be over 99% effective in preventing pregnancy when taken as directed within 120 hours of intercourse.
3. Common adverse reactions included headache, nausea and menstrual irregularities. UPA should not be used by women with current or history of certain cancers, liver disease or high risk of arterial or venous thrombotic diseases.
Effects of intrauterine retention and postmortem interval on body weight following intrauterine death: implications for assessment of fetal growth restriction at autopsy
J Man, JC Hutchinson, M Ashworth, AE Heazell, S Levine and NJ Sebire
Volume 47, Issue 11; Date: November, pages 574–578
Read the free-access article here: http://onlinelibrary.wiley.com/doi/10.1002/uog.16018/full
Organ weights and ratios for postmortem identification of fetal growth restriction: utility and confounding factors
J Man, JC Hutchinson, M Ashworth, I Jeffrey, AE Heazell, and NJ Sebire
Volume 48, Issue 5; Date: November, pages 585–590
Read the free-access article here: http://onlinelibrary.wiley.com/doi/10.1002/uog.16017/full
Longitudinal hemodynamics in acute phase of treatment with labetalol in hypertensive pregnant women to predict need for vasodilatory therapy
D. Stott, M. Bolten, D. Paraschiv, I. Papastefanou, J.B. Chambers and N.A. Kametas
Volume 49, Issue 1, Date: January (pages 85–94)
Read the free-access article here: http://onlinelibrary.wiley.com/doi/10.1002/uog.17335/full
Serial hemodynamic monitoring to guide treatment of maternal hypertension leads to reduction in severe hypertension
D. Stott, I. Papastefanou, D. Paraschiv, K. Clark and N.A. Kametas
Volume 49, Issue 1, Date: January (pages 95–103)
Read the free-access article here: http://onlinelibrary.wiley.com/doi/10.1002/uog.17341/full
Slides prepared by Dr Katherine Goetzinger (UOG Editor for Trainees)
Live birth by fallopian tube sperm perfusion in hyperprolactinemic woman afte...lukeman Joseph Ade shittu
The case presented describes a live birth following treatment of a 35-year-old woman with fallopian tube sperm perfusion (FTSP) using donor sperm after three-repeated unsuccessful courses of In-vitro fertilization (IVF) with Percutaneous Epididymal Sperm Aspiration (PESA), Testicular Sperm Extraction (TESE), and donor sperm. The indication of FTSP is hereby explored and discussed.
This Medication Use Evaluation reviewed 31 patients who received parenteral nutrition at Palms West Hospital between November 2014 and January 2015. The objectives were to evaluate appropriate use of parenteral nutrition and determine if it was prescribed and used appropriately. The summary found that while parenteral nutrition was appropriately initiated in some patients, it was prescribed for too short a duration in others and in some patients who could have received nutrition orally or enterally. Recommendations included requiring nutrition and GI consults prior to prescribing, prioritizing NPO status, explaining risks to non-critically ill patients, consulting pharmacy during therapy, ordering specialized formulations for diabetics, and monitoring for and treating hyperglycemia.
This document discusses several studies and guidelines related to fertility treatments. It provides recommendations on:
- Performing hysteroscopic procedures before IVF to improve outcomes for patients with failed ART cycles.
- Cabergoline reducing OHSS risk with IVF without compromising pregnancy rates.
- AFC and AMH being better predictors of ovarian response than FSH.
- No need for FSH doses over 300IU to increase pregnancy rates.
- Laparoscopic approach for ectopic pregnancy being less costly than open surgery, though open has lower persistent trophoblast rates. Medical treatment is also an option.
Do Women With Polycystic Morphology Without Any Other Features of PCOS Benefi...Alex Swanton
Women with ovaries of polycystic morphology (PCO), without any other features of polycystic ovary syndrome(PCOS), respond similarly to women with PCOS when stimulated with exogenous gonadotrophins, and both groups share various endocrinological disturbances underlying their pathology.
This document summarizes three clinical studies on IVF outcomes for women with PCOS:
1. A study comparing fresh versus frozen-thawed embryo transfer, finding higher clinical pregnancy and live birth rates with fresh transfers.
2. An analysis of over 4,000 IVF cycles from SART, finding no significant difference in outcomes between IVF and ICSI for couples with PCOS and normal sperm.
3. A study examining the impact of metformin on outcomes in overweight/obese PCOS women, with conflicting previous results noted.
Low dose aspirin and low molecular weight heparin in recurrent miscarriageDr. Aisha M Elbareg
This study compared the effects of low dose aspirin alone versus low dose aspirin combined with low-molecular-weight heparin in treating 150 Libyan women with a history of recurrent miscarriages. Women received either low dose aspirin daily or low dose aspirin daily plus low-molecular-weight heparin injections. The combination therapy resulted in significantly fewer miscarriages and more live births compared to aspirin alone. There were no significant differences in preterm birth rates or birth weights between the groups. The combination of low dose aspirin and low-molecular-weight heparin was found to be more effective than low dose aspirin alone in maintaining pregnancy for women with a history of recurrent first trimester
This study compared the analgesic efficacy of intravenous paracetamol versus intramuscular pethidine for labor pain in primigravid women undergoing normal vaginal delivery. 80 women were randomly assigned to receive either 1000mg intravenous paracetamol or 50mg intramuscular pethidine for labor pain. Pain levels were assessed after delivery using a visual analogue scale. The average pain score was significantly lower in the paracetamol group compared to the pethidine group. No significant complications occurred in either group. The study concluded that intravenous paracetamol provides more effective labor pain relief than intramuscular pethidine for normal vaginal deliveries.
This document summarizes management strategies for menopausal symptoms in breast cancer survivors. It discusses pharmacological options like clonidine, oxybutynin, antidepressants, black cohosh, and phytoestrogens. It also covers mind-body practices like cognitive behavioral therapy and hypnosis. Non-hormonal treatments for vulvo-vaginal symptoms are discussed, as well as short-term low dose local estrogen therapy. Management of menopausal symptoms requires a personalized approach balancing symptom relief and safety.
RCT of the effects of Metformin Vs COCs in adolescent PCOS women through a 2...Aboubakr Elnashar
This randomized controlled trial compared the effects of metformin and combined oral contraceptives (COCs) in adolescent women with polycystic ovary syndrome (PCOS) over 24 months. 119 adolescent girls were randomly assigned to receive metformin, COCs, or no treatment (control group). Both metformin and COCs significantly improved cycle regularity and hirsutism compared to the control group. However, metformin was associated with significant improvement in insulin sensitivity, while COCs deteriorated insulin sensitivity. The study concludes that metformin and COCs have comparable effects on symptoms, but metformin may have metabolic advantages in adolescent PCOS patients.
This research article describes a study of 127 premature infants diagnosed with necrotizing enterocolitis (NEC) who were treated with either medical or surgical interventions. 88 infants were treated medically, with 54 responding well and 34 requiring laparoscopy. 39 infants underwent emergency surgery. Overall, medical treatment had a 61.4% success rate and lower mortality and morbidity compared to surgical treatment. For infants not responding to medical care, bedside laparoscopy provided diagnostic and therapeutic benefits and reduced the need for emergency surgery in some cases. The study aims to outline treatment approaches and outcomes for NEC to improve management of this serious condition in preterm infants.
Surgical treatment for hydrosalpinx prior to in‐vitro fertilization embryo transfer: a network meta‐analysis
A. Tsiami, A. Chaimani, D. Mavridis, M. Siskou, E. Assimakopoulos, A. Sotiriadis
Volume 48, Issue 4, Pages 434–445
Slides prepared by Dr Shireen Meher (UOG Editor for Trainees)
Link to free-access article: http://onlinelibrary.wiley.com/doi/10.1002/uog.15900/full
Pregnancy outcome in women presenting with reduced fetal movements.
The study aims to evaluate maternal and perinatal outcomes in pregnant women presenting primarily with reduced fetal movements in the third trimester. Women experiencing reduced fetal movements will undergo assessments including CTG, ultrasound, and Doppler to evaluate fetal well-being. Pregnancy outcomes such as gestational age at delivery, mode of delivery, birthweight, and complications will be analyzed. The results could help improve management of reduced fetal movement cases in the future.
The document provides information about the qualifications and achievements of Dr. Laxmi Shrikhande. It lists her positions including Chairperson Elect of ICOG, National Corresponding Editor of a journal, founder and president of various organizations. It also lists some of the awards she has received for her work in women's health and related fields. The document then provides her name and credentials as Medical Director of Shrikhande Fertility Clinic in Nagpur, Maharashtra.
This document analyzes histomorphologic changes in placentas from pregnancies complicated by hypertension. Placentas from 50 normal pregnancies and 50 pregnancies with hypertension were examined. Microscopic analysis found significantly increased villous abnormalities in placentas from pregnancies with hypertension, including higher rates of syncytial knots, decreased vasculo-syncytial membranes, more fibrinoid necrosis, thicker basement membranes, and more villous stromal fibrosis. These findings suggest reduced blood flow in the placenta among pregnancies with hypertension, which can impact fetal and maternal health.
LNG-IUS: heavy menstrual bleeding What is new??? Dr. Jyoti Agarwal / Dr. Sha...Lifecare Centre
The document discusses the use of levonorgestrel-releasing intrauterine systems (LNG-IUS), such as Mirena, for treating heavy menstrual bleeding. It provides an overview of LNG-IUS, including how it works locally in the uterus to reduce bleeding. Studies show LNG-IUS reduces bleeding by over 90% and is more effective than oral treatments. It is recommended as the first-line treatment for heavy bleeding by international guidelines and has fewer side effects than other options like endometrial ablation or hysterectomy. LNG-IUS is found to improve quality of life more than surgical treatments and is more cost-effective in the long run.
This retrospective study analyzed 477 cases of neonatal hypoglycemia over one year and compared maternal glycemic parameters to neonatal outcomes. 33.1% of mothers had abnormal glucose challenge test (GCT) screens while there was no significant difference between those with abnormal GCTs and one or two abnormal oral glucose tolerance tests. Babies born to mothers with abnormal GCTs had lower birth weights but no differences in APGAR scores or C-section rates. The study concludes that abnormal GCTs can identify mothers at risk of having babies with hypoglycemia and higher risks of obesity, and that earlier detection of at-risk mothers could help reduce NICU admissions and long-term childhood obesity.
Prefabricated homes speed up construction time and results in lower labour costs. Prefabrication allows for year-round construction. There are less wasted materials than in site-built construction. work is not affected by weather delays (related to excessive cold, heat, rain, snow, etc).For more visit http://www.greenrpanel.com/
Schizophrenia is a thought disorder characterized by positive, negative, cognitive, and mood symptoms. While the true cause is unknown, there are several theories involving dopamine and glutamate imbalances. Diagnosis requires symptoms for over 6 months and significant impairment in functioning. Treatment involves first-generation antipsychotics like chlorpromazine or second-generation antipsychotics like clozapine, risperidone, and olanzapine. Two major studies, CATIE and CUtLASS, found few differences in effectiveness between first and second-generation drugs, though second-generation drugs had fewer side effects in some cases.
1. The document provides information on the emergency contraceptive ulipristal acetate (UPA), including its mechanism of action, pharmacokinetics, clinical evaluations in randomized studies, contraindications, precautions, adverse reactions and drug interactions.
2. Key points include that UPA prevents pregnancy by inhibiting or delaying ovulation and altering the endometrium; clinical trials found it to be over 99% effective in preventing pregnancy when taken as directed within 120 hours of intercourse.
3. Common adverse reactions included headache, nausea and menstrual irregularities. UPA should not be used by women with current or history of certain cancers, liver disease or high risk of arterial or venous thrombotic diseases.
Effects of intrauterine retention and postmortem interval on body weight following intrauterine death: implications for assessment of fetal growth restriction at autopsy
J Man, JC Hutchinson, M Ashworth, AE Heazell, S Levine and NJ Sebire
Volume 47, Issue 11; Date: November, pages 574–578
Read the free-access article here: http://onlinelibrary.wiley.com/doi/10.1002/uog.16018/full
Organ weights and ratios for postmortem identification of fetal growth restriction: utility and confounding factors
J Man, JC Hutchinson, M Ashworth, I Jeffrey, AE Heazell, and NJ Sebire
Volume 48, Issue 5; Date: November, pages 585–590
Read the free-access article here: http://onlinelibrary.wiley.com/doi/10.1002/uog.16017/full
Longitudinal hemodynamics in acute phase of treatment with labetalol in hypertensive pregnant women to predict need for vasodilatory therapy
D. Stott, M. Bolten, D. Paraschiv, I. Papastefanou, J.B. Chambers and N.A. Kametas
Volume 49, Issue 1, Date: January (pages 85–94)
Read the free-access article here: http://onlinelibrary.wiley.com/doi/10.1002/uog.17335/full
Serial hemodynamic monitoring to guide treatment of maternal hypertension leads to reduction in severe hypertension
D. Stott, I. Papastefanou, D. Paraschiv, K. Clark and N.A. Kametas
Volume 49, Issue 1, Date: January (pages 95–103)
Read the free-access article here: http://onlinelibrary.wiley.com/doi/10.1002/uog.17341/full
Slides prepared by Dr Katherine Goetzinger (UOG Editor for Trainees)
Live birth by fallopian tube sperm perfusion in hyperprolactinemic woman afte...lukeman Joseph Ade shittu
The case presented describes a live birth following treatment of a 35-year-old woman with fallopian tube sperm perfusion (FTSP) using donor sperm after three-repeated unsuccessful courses of In-vitro fertilization (IVF) with Percutaneous Epididymal Sperm Aspiration (PESA), Testicular Sperm Extraction (TESE), and donor sperm. The indication of FTSP is hereby explored and discussed.
This Medication Use Evaluation reviewed 31 patients who received parenteral nutrition at Palms West Hospital between November 2014 and January 2015. The objectives were to evaluate appropriate use of parenteral nutrition and determine if it was prescribed and used appropriately. The summary found that while parenteral nutrition was appropriately initiated in some patients, it was prescribed for too short a duration in others and in some patients who could have received nutrition orally or enterally. Recommendations included requiring nutrition and GI consults prior to prescribing, prioritizing NPO status, explaining risks to non-critically ill patients, consulting pharmacy during therapy, ordering specialized formulations for diabetics, and monitoring for and treating hyperglycemia.
This document discusses several studies and guidelines related to fertility treatments. It provides recommendations on:
- Performing hysteroscopic procedures before IVF to improve outcomes for patients with failed ART cycles.
- Cabergoline reducing OHSS risk with IVF without compromising pregnancy rates.
- AFC and AMH being better predictors of ovarian response than FSH.
- No need for FSH doses over 300IU to increase pregnancy rates.
- Laparoscopic approach for ectopic pregnancy being less costly than open surgery, though open has lower persistent trophoblast rates. Medical treatment is also an option.
Do Women With Polycystic Morphology Without Any Other Features of PCOS Benefi...Alex Swanton
Women with ovaries of polycystic morphology (PCO), without any other features of polycystic ovary syndrome(PCOS), respond similarly to women with PCOS when stimulated with exogenous gonadotrophins, and both groups share various endocrinological disturbances underlying their pathology.
This document summarizes three clinical studies on IVF outcomes for women with PCOS:
1. A study comparing fresh versus frozen-thawed embryo transfer, finding higher clinical pregnancy and live birth rates with fresh transfers.
2. An analysis of over 4,000 IVF cycles from SART, finding no significant difference in outcomes between IVF and ICSI for couples with PCOS and normal sperm.
3. A study examining the impact of metformin on outcomes in overweight/obese PCOS women, with conflicting previous results noted.
Low dose aspirin and low molecular weight heparin in recurrent miscarriageDr. Aisha M Elbareg
This study compared the effects of low dose aspirin alone versus low dose aspirin combined with low-molecular-weight heparin in treating 150 Libyan women with a history of recurrent miscarriages. Women received either low dose aspirin daily or low dose aspirin daily plus low-molecular-weight heparin injections. The combination therapy resulted in significantly fewer miscarriages and more live births compared to aspirin alone. There were no significant differences in preterm birth rates or birth weights between the groups. The combination of low dose aspirin and low-molecular-weight heparin was found to be more effective than low dose aspirin alone in maintaining pregnancy for women with a history of recurrent first trimester
This study compared the analgesic efficacy of intravenous paracetamol versus intramuscular pethidine for labor pain in primigravid women undergoing normal vaginal delivery. 80 women were randomly assigned to receive either 1000mg intravenous paracetamol or 50mg intramuscular pethidine for labor pain. Pain levels were assessed after delivery using a visual analogue scale. The average pain score was significantly lower in the paracetamol group compared to the pethidine group. No significant complications occurred in either group. The study concluded that intravenous paracetamol provides more effective labor pain relief than intramuscular pethidine for normal vaginal deliveries.
This document summarizes management strategies for menopausal symptoms in breast cancer survivors. It discusses pharmacological options like clonidine, oxybutynin, antidepressants, black cohosh, and phytoestrogens. It also covers mind-body practices like cognitive behavioral therapy and hypnosis. Non-hormonal treatments for vulvo-vaginal symptoms are discussed, as well as short-term low dose local estrogen therapy. Management of menopausal symptoms requires a personalized approach balancing symptom relief and safety.
RCT of the effects of Metformin Vs COCs in adolescent PCOS women through a 2...Aboubakr Elnashar
This randomized controlled trial compared the effects of metformin and combined oral contraceptives (COCs) in adolescent women with polycystic ovary syndrome (PCOS) over 24 months. 119 adolescent girls were randomly assigned to receive metformin, COCs, or no treatment (control group). Both metformin and COCs significantly improved cycle regularity and hirsutism compared to the control group. However, metformin was associated with significant improvement in insulin sensitivity, while COCs deteriorated insulin sensitivity. The study concludes that metformin and COCs have comparable effects on symptoms, but metformin may have metabolic advantages in adolescent PCOS patients.
This research article describes a study of 127 premature infants diagnosed with necrotizing enterocolitis (NEC) who were treated with either medical or surgical interventions. 88 infants were treated medically, with 54 responding well and 34 requiring laparoscopy. 39 infants underwent emergency surgery. Overall, medical treatment had a 61.4% success rate and lower mortality and morbidity compared to surgical treatment. For infants not responding to medical care, bedside laparoscopy provided diagnostic and therapeutic benefits and reduced the need for emergency surgery in some cases. The study aims to outline treatment approaches and outcomes for NEC to improve management of this serious condition in preterm infants.
Surgical treatment for hydrosalpinx prior to in‐vitro fertilization embryo transfer: a network meta‐analysis
A. Tsiami, A. Chaimani, D. Mavridis, M. Siskou, E. Assimakopoulos, A. Sotiriadis
Volume 48, Issue 4, Pages 434–445
Slides prepared by Dr Shireen Meher (UOG Editor for Trainees)
Link to free-access article: http://onlinelibrary.wiley.com/doi/10.1002/uog.15900/full
Pregnancy outcome in women presenting with reduced fetal movements.
The study aims to evaluate maternal and perinatal outcomes in pregnant women presenting primarily with reduced fetal movements in the third trimester. Women experiencing reduced fetal movements will undergo assessments including CTG, ultrasound, and Doppler to evaluate fetal well-being. Pregnancy outcomes such as gestational age at delivery, mode of delivery, birthweight, and complications will be analyzed. The results could help improve management of reduced fetal movement cases in the future.
The document provides information about the qualifications and achievements of Dr. Laxmi Shrikhande. It lists her positions including Chairperson Elect of ICOG, National Corresponding Editor of a journal, founder and president of various organizations. It also lists some of the awards she has received for her work in women's health and related fields. The document then provides her name and credentials as Medical Director of Shrikhande Fertility Clinic in Nagpur, Maharashtra.
This document analyzes histomorphologic changes in placentas from pregnancies complicated by hypertension. Placentas from 50 normal pregnancies and 50 pregnancies with hypertension were examined. Microscopic analysis found significantly increased villous abnormalities in placentas from pregnancies with hypertension, including higher rates of syncytial knots, decreased vasculo-syncytial membranes, more fibrinoid necrosis, thicker basement membranes, and more villous stromal fibrosis. These findings suggest reduced blood flow in the placenta among pregnancies with hypertension, which can impact fetal and maternal health.
LNG-IUS: heavy menstrual bleeding What is new??? Dr. Jyoti Agarwal / Dr. Sha...Lifecare Centre
The document discusses the use of levonorgestrel-releasing intrauterine systems (LNG-IUS), such as Mirena, for treating heavy menstrual bleeding. It provides an overview of LNG-IUS, including how it works locally in the uterus to reduce bleeding. Studies show LNG-IUS reduces bleeding by over 90% and is more effective than oral treatments. It is recommended as the first-line treatment for heavy bleeding by international guidelines and has fewer side effects than other options like endometrial ablation or hysterectomy. LNG-IUS is found to improve quality of life more than surgical treatments and is more cost-effective in the long run.
This retrospective study analyzed 477 cases of neonatal hypoglycemia over one year and compared maternal glycemic parameters to neonatal outcomes. 33.1% of mothers had abnormal glucose challenge test (GCT) screens while there was no significant difference between those with abnormal GCTs and one or two abnormal oral glucose tolerance tests. Babies born to mothers with abnormal GCTs had lower birth weights but no differences in APGAR scores or C-section rates. The study concludes that abnormal GCTs can identify mothers at risk of having babies with hypoglycemia and higher risks of obesity, and that earlier detection of at-risk mothers could help reduce NICU admissions and long-term childhood obesity.
Prefabricated homes speed up construction time and results in lower labour costs. Prefabrication allows for year-round construction. There are less wasted materials than in site-built construction. work is not affected by weather delays (related to excessive cold, heat, rain, snow, etc).For more visit http://www.greenrpanel.com/
Schizophrenia is a thought disorder characterized by positive, negative, cognitive, and mood symptoms. While the true cause is unknown, there are several theories involving dopamine and glutamate imbalances. Diagnosis requires symptoms for over 6 months and significant impairment in functioning. Treatment involves first-generation antipsychotics like chlorpromazine or second-generation antipsychotics like clozapine, risperidone, and olanzapine. Two major studies, CATIE and CUtLASS, found few differences in effectiveness between first and second-generation drugs, though second-generation drugs had fewer side effects in some cases.
This document discusses several types of anxiety disorders and their treatments. It describes anxiety as an emotional state caused by perceived danger, and anxiety disorders as the most common mental disorders characterized by uncomfortable and debilitating symptoms. The main anxiety disorders covered are general anxiety disorder, panic disorder, social anxiety disorder, post-traumatic stress disorder, and obsessive-compulsive disorder. For each disorder, the document outlines diagnostic criteria and recommended first-, second-, and third-line medication treatments, including SSRIs, SNRIs, benzodiazepines, and other drugs. It also provides dosing guidelines for several common benzodiazepine medications used to treat anxiety.
Groups Facility & Services provides security management, facility management, and consultancy services. It was founded in 2007 and offers services like armed guards, housekeeping, and facility management. The company's mission is to provide a safe and secure environment for clients through quality and affordable services. It aims to satisfy customers and has a team of professionals from security, facility management, and other backgrounds.
This document contains details about an individual seeking a position as an Associated General Manager or Senior Project Manager. It includes information about their current and permanent addresses, contact details, 35 years of experience in project management and construction management in India and abroad, areas of expertise including managing projects, budgets, and teams, and a history of roles and responsibilities in various companies. It also provides a resume, professional summary, areas of expertise, details of past construction projects, education details, and personal details of the individual.
Sharjah Waterfront City | Project ProfileSharjahOasis
This document provides information about Sharjah Waterfront City (SWFC) project in Sharjah, UAE. Some key details include:
- SWFC will be built on 8 islands spread over 36km of coastal land in Sharjah. It will include 200 towers, 95 apartment buildings, over 1100 waterfront villas, hotels, shopping malls, and amenities to accommodate over 200,000 residents.
- Phase 1 will be developed over the next 3 years on two islands and include 298 plots for mixed-use, hospitality, residential, and commercial development totaling over 15 million square feet of construction.
- The hospitality segment in Phase 1 includes 3 plots that will be developed with hotels and service apartments offering
This study examined the effects of adding estradiol valerate (EV) to clomiphene citrate (CC)-stimulated cycles on endometrial thickness. Thirty women received CC for ovulation induction in two treatment cycles, with one group also receiving a placebo and the other group receiving additional EV. While CC alone slightly reduced endometrial thickness, the addition of EV significantly increased thickness compared to CC with placebo. EV especially improved endometrial thickness in women where CC caused thinning, but had little effect where thickness was normal with CC alone. Other measures of folliculogenesis and ovulation were unaffected by EV. The study concluded EV prevents CC-induced endometrial thinning without disrupting the ovulation process.
The IOSR Journal of Pharmacy (IOSRPHR) is an open access online & offline peer reviewed international journal, which publishes innovative research papers, reviews, mini-reviews, short communications and notes dealing with Pharmaceutical Sciences( Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy & Phytochemistry, Pharmacology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest........more details on Aim & Scope).
All manuscripts are subject to rapid peer review. Those of high quality (not previously published and not under consideration for publication in another journal) will be published without delay.
LETROZOLE WITH TIMED INTERCOURSE VERSUS CLOMIPHENE CITRATE WITH IUIJoe Lee
This study compared pregnancy outcomes in 7,764 patients with unexplained infertility who underwent controlled ovarian stimulation (COS) with either letrozole (LET) and timed intercourse (IC) or clomiphene citrate (CC) and intrauterine insemination (IUI). Clinical pregnancy rates were significantly higher in the LET-IC group compared to the CC-IUI group (15.0% vs 11.8% for IC, 12.3% vs 11.5% for IUI). Endometrial thickness and follicular response were also higher in the LET group. The study concluded that unexplained infertility patients have better pregnancy outcomes with LET stimulation and timed IC compared to CC stimulation and timed ICI
This study tested the hypothesis that restricting a pregnant woman's intake of polyphenol-rich foods for at least two weeks improves ductus arteriosus blood flow dynamics in healthy third-trimester fetuses, as was previously shown in fetuses with ductal constriction. 46 pregnant women restricted their polyphenol intake from an average of 1277 mg/day to 126 mg/day. Their fetuses showed significant decreases in ductal velocities and RV/LV ratio, and an increase in ductal pulsatility index. A control group of 26 women showed no significant changes. The study suggests that reducing maternal polyphenol intake improves fetal ductal hemodynamics in normal pregnancies.
Dr. Sharda Jain, Dr. Jyoti Agarwal, and Dr. Jyoti Bhaskar presented an interactive session on the medical management of dysfunctional uterine bleeding (DUB) in 2014. Ormeloxifene, a selective estrogen receptor modulator, was discussed as a non-steroidal treatment option for DUB that has shown efficacy in several pilot studies and randomized controlled trials. Ormeloxifene has advantages of a convenient dosing schedule and few side effects, and has been used to successfully treat over 700 patients with DUB. Feedback was encouraged from participants on experiences treating DUB.
Ondansetron is a selective 5-HT3 receptor antagonist used to prevent chemotherapy-induced nausea and vomiting. It is administered intravenously or intramuscularly. In clinical trials:
- Ondansetron 0.15 mg/kg administered intravenously was more effective than lower or higher doses in preventing nausea and vomiting from cancer chemotherapy.
- Ondansetron was significantly more effective than placebo in preventing nausea and vomiting induced by cisplatin-based chemotherapy in a study of 28 patients. Fewer patients who received ondansetron experienced vomiting or had early onset of vomiting compared to placebo.
- Pediatric cancer patients younger than 18 generally had higher drug clearance
This study examined the effects of restricting polyphenol-rich foods in the diets of pregnant women in their third trimester on fetal ductal flow dynamics. 46 pregnant women consuming high levels of polyphenols were asked to restrict these foods for 2 weeks or more. Their fetuses showed significant decreases in ductal blood flow velocities and right ventricular size, as well as an increase in ductal pulsatility index. A control group of 26 women showed no significant changes. The study suggests that restricting maternal polyphenol intake in the third trimester can improve fetal ductal flow and right heart dimensions in normal pregnancies, as seen previously in cases of ductal constriction.
The comparison of dinoprostone and vagiprost for induction of lobar in post t...iosrphr_editor
The IOSR Journal of Pharmacy (IOSRPHR) is an open access online & offline peer reviewed international journal, which publishes innovative research papers, reviews, mini-reviews, short communications and notes dealing with Pharmaceutical Sciences( Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy & Phytochemistry, Pharmacology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest........more details on Aim & Scope).
This study evaluated the impact of standard- and high-dose GnRH antagonists compared to a GnRH agonist on endometrial development in women undergoing controlled ovarian stimulation for oocyte donation. Thirty-one women were treated with either a standard dose of ganirelix, a high dose of ganirelix, or buserelin. Endometrial biopsies on days 2 and 7 after HCG administration found that development was similar in the standard- and high-dose ganirelix groups and comparable to natural cycles, but development was arrested in the buserelin group. Gene expression patterns after ganirelix more closely matched natural cycles than after buserelin. The study concluded that
This study compared ovarian response, oocyte and embryo quality, and pregnancy rates between PCOS and non-PCOS patients undergoing IVF. The main findings were:
1. PCOS patients had more follicles on the day of retrieval but fewer mature oocytes and top-quality embryos compared to non-PCOS patients.
2. The recovery rates of oocytes and mature oocytes per follicle were lower in the PCOS group.
3. Pregnancy rates were comparable between the two groups despite differences in ovarian response and embryo quality.
Tegaserod, a 5-HT4 receptor partial agonist, provided rapid and sustained relief of abdominal pain, bloating, and constipation associated with irritable bowel syndrome (IBS) in a 12-week randomized controlled trial. Tegaserod at doses of 2 mg and 6 mg twice daily significantly improved overall IBS symptoms and individual symptoms like abdominal pain and discomfort, number of bowel movements, and stool consistency compared to placebo. Tegaserod was well tolerated with only transient diarrhea occurring more frequently than placebo. The study demonstrates that tegaserod offers effective relief of multiple IBS symptoms.
Ormeloxifene is an effective and safe treatment for dysfunctional uterine bleeding. A study of 60 women found that ormeloxifene significantly reduced menstrual blood loss and increased hemoglobin levels after both 3 and 6 months of treatment. It also significantly decreased endometrial thickness. The majority of women reported marked improvement in symptoms and found ormeloxifene acceptable with minimal side effects. Ormeloxifene is thus a good alternative for managing dysfunctional uterine bleeding.
A COMPARATIVE ANALYSIS OF HEMATOLOGICAL INDICES IN PREGNANT WOMEN AND NON PR...FidelityP
Red blood cell (RBC) indices are individual components of a routine blood test called the complete blood count (CBC). The CBC is used to measure the quantity and physical characteristics of different types of cells found in your blood. Blood consists of RBCs, white blood cells (WBCs), and platelets that are suspended in your plasma. Platelets are cells that enable clot formation. RBCs contain hemoglobin, which carries oxygen throughout your body to all of your tissues and organs. An RBC is pale red and gets its color from hemoglobin. It’s shaped like a doughnut, but it has a thinner area in the middle instead of a hole. Your RBCs are normally all the same color, size, and shape. However, certain conditions can cause variations that impair their ability to function properly. The RBC indices measure the size, shape, and physical characteristics of the RBCs. Your doctor can use RBC indices to help diagnose the cause of anemia. Anemia is a common blood disorder in which you have too few, misshapen, or poorly functional RBCs123
International Journal of Pharmaceutical Science Invention (IJPSI)inventionjournals
International Journal of Pharmaceutical Science Invention (IJPSI) is an international journal intended for professionals and researchers in all fields of Pahrmaceutical Science. IJPSI publishes research articles and reviews within the whole field Pharmacy and Pharmaceutical Science, new teaching methods, assessment, validation and the impact of new technologies and it will continue to provide information on the latest trends and developments in this ever-expanding subject. The publications of papers are selected through double peer reviewed to ensure originality, relevance, and readability. The articles published in our journal can be accessed online
Study design: A Randomized prospective comparable study.
Objective: To compare the effi cacy of GnRH agonist stop antagonist and GnRH antagonist protocols in ICSI outcome for women
who are expected to have poor ovarian response.
Setting: ART unit of Obstetrics and Gynecology Department of Qena University Hospital, South Valley University, Egypt.
Duration: From September 2016 to December 2017.
This document summarizes research on the effects of alternative hormonal treatments, including bazedoxifene, on various tissues in humans. It discusses preclinical and clinical data on the effects of ospemifene, tamoxifen, raloxifene, and bazedoxifene on the endometrium, vagina, breast, and bone. It then summarizes results from several clinical trials, known as the SMART trials, that evaluated the efficacy and safety of a combination of conjugated estrogens and bazedoxifene for vasomotor symptoms, quality of life, vaginal health, and bone mineral density and fracture risk reduction.
1) A randomized controlled trial evaluated the efficacy of an oral contraceptive containing estradiol valerate and dienogest in treating heavy menstrual bleeding.
2) 180 women with heavy menstrual bleeding were randomized to receive either the oral contraceptive or placebo for 196 days.
3) The oral contraceptive was highly effective, with 43.8% of women experiencing a complete response compared to 4.2% for placebo. It significantly reduced menstrual blood loss and improved iron levels.
Explore the intricacies of ovulation induction in intrauterine insemination (IUI) with Dr Laxmi Shrikhande's informative slide share presentation. From understanding the hormonal mechanisms to the latest techniques, this presentation offers insights into optimizing fertility through IUI. Whether you're a clinician seeking to enhance patient outcomes or an individual navigating fertility treatments, this resource provides valuable knowledge for your journey towards conception.
This randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of tegaserod in treating female patients with irritable bowel syndrome characterized by abdominal pain/discomfort and constipation. 1519 women were randomized to receive either tegaserod 6 mg twice daily or placebo for 12 weeks. The primary outcome was the Subject's Global Assessment of Relief, which assessed overall symptom relief. Secondary outcomes included assessments of abdominal pain, bowel habits, and bloating. Results showed tegaserod produced statistically significant improvements in the primary and secondary outcomes compared to placebo. The most common side effect was diarrhea, but this led to discontinuation in only 1.6% of patients receiving tegaserod. Therefore
The thin endometrium refers to the lining of the uterus, known as the endometrium, being insufficiently thick. This condition is typically characterized by a reduced thickness of the endometrial layer, which plays a crucial role in supporting the implantation and development of a fertilized egg during the menstrual cycle.
A thin endometrium is commonly associated with hormonal imbalances, such as low estrogen levels, which are vital for the growth and maintenance of the endometrial tissue. Inadequate blood flow to the uterus, chronic inflammation, or certain medical conditions can also contribute to this condition. Women with a thin endometrium may experience difficulties in achieving and maintaining pregnancy, as the thin lining may not provide an optimal environment for the embryo to implant and thrive.
Addressing the underlying causes of a thin endometrium often involves hormonal therapies to regulate estrogen levels, lifestyle modifications, and sometimes surgical interventions. Fertility treatments, such as in vitro fertilization (IVF), may be considered to overcome the challenges associated with a thin endometrium.
In conclusion, a thin endometrium can pose challenges to fertility and reproductive health, requiring a comprehensive approach to address the underlying factors and improve the chances of successful conception.
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COMPREHENSIVE MEDICATION EVALUATION
Amethia, Ashlyna, Camrese, Daysee, Introvale, Jolessa, Quartette, Quasense, Seasonale, Seasonique, Setlakin
Catawba Unit
Indian Health Service
Department of Pharmacy Services
INTRODUCTION: In 2010, there were 42,000 unintended pregnancies in South Carolina alone.1 Approximately 2.8 million
unintended pregnancies occur in the United States each year; in every 1000 women between ages 15-19 in 2009, 55.5
American Indian/Alaska Natives gave birth compared to 25.6 whites.2 There is a clear need for access to contraceptives
in the Native American community. While 28-day cyclic regimen birth control is available, many women desire to
lessen the frequency of the cyclic menstrual period. As there is no medical need for monthly menstruation, it is a
worthwhile endeavor to provide prevention of menstrual pain and inconvenience.3 In addition to lessening menstrual
symptoms, continuous oral contraceptives may be effective at reducing symptoms related to other gynecologic
conditions such as ovarian cysts,pelvic pain, and endometriosis. Efficacy studies ofextended and continuouscycle OCPs
demonstrate that these regimens are as effective as cyclic administration.3
GENERIC: ethinyl estradiol and levonorgestrel (extended-cycle)4
TRADE NAME & MANUFACTURER: Amethia (Watson), Ashlyna (Glenmark Generics Ltd), Camrese (Teva), Daysee (Teva),
Introvale (Sandoz),Jolessa (Teva),Quartette (Teva),Quasense (Watson),Seasonale (Sandoz),Seasonique (Teva),Setlakin
(Northstar RxLLC)4
AHFS CATEGORY AND PHARMACOLOGICAL CLASS: 68.68.12 Contraceptives, oral4
FDA APPROVAL DATE and REVIEW CLASSIFICATION: Approved September5,2003. Classified standard reviewdrug5
INDICATIONS: Prevention of pregnancy4
CLINICAL PHARMACOLOGY:
Mechanismof action: Combination oral contraceptives act by suppression of gonadotropins. Although the
primary mechanism of this action is inhibition of ovulation,otheralterations include changes in the cervical mucus (which
increase the difficulty of sperm entry into the uterus) and changes in the endometrium (which reduce the likelihood of
implantation).4
PHARMACOKINETICS:
Absorption: No specific investigation of the absolute bioavailability of Seasonale in humans has been conducted.
However, literature indicates that levonorgestrel is rapidly and completely absorbed after oral administration
(bioavailability nearly 100%) and is not subject to first-pass metabolism. Ethinyl estradiol is rapidly and almost
completely absorbed from the gastrointestinal tract but, due to first-pass metabolism in gut mucosa and liver, the
bioavailability of ethinyl estradiol is approximately 43%.4
Distribution: The apparent volume of distribution of levonorgestrel and ethinyl estradiol are reported to
be approximately 1.8 L/kg and 4.3 L/kg, respectively.Levonorgestrelis about 97.5 - 99% protein-bound,principally to sex
hormone binding globulin (SHBG) and, to a lesser extent, serum albumin. Ethinyl estradiol is about 95 - 97% bound to
serum albumin. Ethinyl estradiol does not bind to SHBG, but induces SHBG synthesis, which leads to decreased
levonorgestrel clearance. Following repeated daily dosing of combination levonorgestrel/ethinyl estradiol oral
contraceptives,levonorgestrelplasma concentrations accumulate more than predicted basedon single-dose kinetics,due in
part,to increased SHBG levels that are induced by ethinylestradiol,and a possible reductionin hepatic metabolic capacity.4
Metabolism:
Ethinyl estradiol: Hepatic via CYP3A4; undergoes first-pass metabolism; forms metabolites
Levonorgestrel: Forms conjugated in unconjugated metabolites4
Elimination: About 45% oflevonorgestreland its metabolites are excreted in the urine and about 32% are excreted in feces,
mostly as glucuronide conjugates.The terminal elimination half-life for levonorgestrelaftera single dose ofSeasonale was
about 30 hours. Ethinylestradiolis excreted in the urine and feces as glucuronide and sulfate conjugates, and it undergoes
enterohepatic recirculation.The terminalelimination half-life ofethinylestradiolaftera single dose ofSeasonale was found
to be about 15 hours.4
2. 2 | P a g e o f 6
CLINICAL EVALUATIONS:
A multicenter, randomized study of an extended cycle oral contraceptive
Population and Study Design: In this parallel,randomized, multicenteropen-label,1-yearstudy,Seasonale [30μg ethinyl
estradiol (EE)/150 μg levonorgestrel (LNG), and Nordette-28 (30 μg EE/150 μg LNG)] was evaluated in sexually active,
adult women (18–40 years) of childbearing potential. This study, known as SEA 301, became the primary data source for
the evidenced-based drugapproval. In the study,patients received eitherfour91-day cycles ofextended cycle regimen OC,
or13 cycles ofthe conventional28-day OCwith daily monitoring ofcompliance and bleeding via electronic diaries. Efficacy
was evaluated as themethod failure rate,calculated by life table analysis and the PearlIndex(the number ofpregnancies per
100 women per year of use) among women aged 18–35 who used the product as directed. Safety was evaluated by
assessment of self-reported adverse events and adverse events elicited at clinic visits,
clinical laboratory tests, vital signs (including weight), and physical examination.6
Anderson FD, Hait H. A multicenter, randomized study of an extended cycle oral contraceptive. Contraception. 2003;68(2):89–96. doi:10.1016/s0010-
7824(03)00141-0.
As evidenced by Table 3, while the initial risk of failure is higher in the extended-cycle regimen than in the conventional
cycle,as time progresses(by the 8th month)the riskis significantly higherthan in the constant failure rate ofextended-cycle
oral contraception.
Results:During the course ofthestudy,7patients became pregnant,4of456 (0.9%) treated with the extendedcycle regimen
and 3 of226 (1.3%) treated with the conventionalregimen. Diary data indicated use of othermethods ofbirth controland/or
noncompliance with study medication around the estimated date of conception for three of four extended cycle regimen
patients and one of three conventional regimen patients. Thus, one extended cycle and two conventional cycle regimen-
reported pregnancies were considered method failures. Adverseevents were comparable across the treatment groups;there
were no clinically meaningful changes in other laboratory values, body weight, vital signs (systolic and diastolic blood
pressure,heart rate ortemperature)orin physicalexam results from baseline to end ofstudy.Also,there were no reports of
endometrial hyperplasia or carcinoma.6
Long-term safety of an extended-cycle oral contraceptive (Seasonale):A 2-year multicenter open-label extensiontrial
Population and Study Design: The purpose ofthis studywas to assess the long-termsafety ofSeasonale; thiswas an open-
label, multicenter study in women who successfully completed 1 year of therapy in the Phase 3 Seasonale clinical trial.
Participants who completed the Phase 3 trial from 27 of the original sites were invited to participate.Patients who received
eitherthe 28-day (Nordette)or 91-day (Seasonale)OC treatments in the earlier study were assignedto the 91-day Seasonale
regimen. The primary objective was to demonstrate the safety of the Seasonale extended-cycle for up to an additional 2
years in women who had participated in the Phase 3 Seasonale clinical trial. The principal means of safety evaluation was
patient-reported adverse events.7
3. 3 | P a g e o f 6
Results: There were 189 women enrolled and treated with Seasonale from the 27 clinical sites. Table I (below) shows the
adverse event profile for the trial by frequency experienced. The most frequently reported adverse events were sinusitis
(19.1%), headache (16.9%), nasopharyngitis (16.4%), upper respiratory tract infection (16.4%), urinary tract infection
(10.1%), and dysmenorrhea (9.5%). The adverse events reported during this study are consistent with other OC clinical
trials, and breakthroughbleeding and/orspotting diminished during the study.This study demonstrates thelong-termsafety
of the 91-day extended cycle OC Seasonale.7
AndersonFD,Gibbons W,PortmanD. Long-termsafetyof anextended-cycleoralcontraceptive (Seasonale): A 2-yearmulticenteropen-labelextension
trial. American Journal ofObstetrics andGynecology.2006;195(1):92–96.doi:10.1016/j.ajog.2005.12.045
Safety and efficacy of an extended-regimen oral contraceptive utilizing continuous low-dose ethinyl estradiol
Population and Study Design: This trial provides detailed results ofa clinical study evaluating the safetyand efficacy of
Seasonique,a 91-day extended-regimen OC consisting of84 days of30 Ag EE/150 Ag LNG followed by 7 days of10 Ag
EE monotherapy. Efficacy was evaluated fromthe pregnancy rate in women ages 18–35 years,who completed at least one
full cycle of therapy,using the Pearlindex(the number of pregnancies per100 women, per yearof use)and life table
analyses.8
Results: Across 36study sites located throughoutthe United States,1006 patients were treated with Seasonique™. A total
of 708 women ages 18–35 years were treated for2177 extended-regimen 91-day cycles (equivalent to 7075 conventional
28-day cycles).During the course ofthe study,five patients became pregnant.Allofthese patients were on treatment at the
time of conception,but only three were consideredto be compliant with pill-taking at the time of conception. Serious
adverse eventsjudged to be possibly related to studydrug were reported in fourpatients.One patient reported a migraine.
The remaining three patients reportedevents related to thegallbladder; cholelithiasis,alone,and with pancreatitis,or
cholecystitis(one patienteach). Seasoniquekwas greaterthan 99% effective in preventing pregnancywhen taken as
directed. This clinical study demonstratesthat giving 10Ag of EE monotherapy during the usualbhormone-freeQinterval
in a 91-day extended regimen does not impact contraceptive efficacy and may contribute to an improvement in
breakthrough bleedingand spotting.8
CONTRAINDICATIONS:
Patient with current/history of breast cancer or other estrogen- or progestin-dependent neoplasms,
Hepatic tumors or disease
Pregnancy
Undiagnosed abnormal uterine bleeding
Women at high risk of arterial or venous thrombotic diseases including: Cerebrovascular disease, coronary artery disease,
diabetes mellitus with vascular disease, DVT or PE (current or history of), hypercoagulopathies (inherited or acquired),
headaches with focal neurological symptoms, hypertension (uncontrolled), migraine headaches if >35 years of age,
thrombogenic valvular or rhythm diseases of the heart (eg, subacute bacterial endocarditis with valvular disease or atrial
fibrillation), women >35 years of age who smoke.4
4. 4 | P a g e o f 6
PRECAUTIONS & WARNINGS:
Black Box Warning-Cigarette smoking increases the risk of serious cardiovascular events from combination oral
contraceptivesuse.Thisriskincreaseswith age,particularly in women over35years ofage,andwith thenumberofcigarettes
smoked. For this reason,combination oral contraceptives should not be used by women who are over35 years of age and
smoke.4
Carbohydrate intolerance: May have adverse effects on glucose tolerance; use caution in women with diabetes.
Lipid effects: Combination hormonal contraceptives may affect serum triglyceride and lipoprotein levels. Estrogen
compounds are generally associated with lipid effects such as increased HDL-cholesterol and decreased LDL-cholesterol.
Triglycerides may also be increased; use with caution in patients with familial defects of lipoprotein metabolism.4
Retinal vascular thrombosis: Estrogens may cause retinal vascular thrombosis; discontinue if migraine, loss of vision,
proptosis,diplopia orothervisualdisturbances occur; discontinue permanently ifpapilledema or retinal vascularlesionsare
observed on examination.4
Thromboembolism: May increase the riskofthromboembolism; discontinueuse ofcombination hormonalcontraceptivesif
an arterial or venous thrombotic event occurs. Women with inherited thrombophilias may have increased risk of venous
thromboembolism. 4
Vaginal bleeding:Presentation ofirregular,unresolving vaginalbleeding warrants furtherevaluation includingendometrial
sampling, if indicated, to rule out malignancy; evaluate hypothalamic-pituitary-function in women with persistent (≥6
months) amenorrhea (especially associated with breast secretion) following discontinuation of therapy.4
ADVERSE REACTIONS: 4
Edema, varicose vein aggravation
Depression, migraine, mood changes
Chloasma, melasma, rash (allergic)
Amenorrhea, breakthrough bleeding, breast changes (enlargement, pain, secretion, tenderness), carbohydrate tolerance
decreased, fluid retention, lactation decreased (with use immediately postpartum), menstrual flow changes, spotting
Abdominal bloating, abdominal cramps, abdominal pain, appetite changes, nausea, weight changes, vomiting
Folate decreased
Rhinitis
TOXICITY:
Toxicity may result in occasionalGI upset; it could also cause a hypersensitivity reaction, but overall the toxicity is low
in non-iron containing OCs. 4
DRUG INTERACTIONS: 4
Avoid combination (category X) with: Amodiaquine, Anastrozole, Antihepaciviral Combination Products,
Dehydroepiandrosterone,Exemestane, Hemin, Indium 111 Capromab Pendetide, Tranexamic Acid, Tizantidine,
Ospemifene
Consider therapy modification (category D) with: Anticoagulants,Aprepitant,Armodafinil, Artemether, Asunaprevir,
Barbiturates, Bexarotene, Bile Acid Sequestrants,Boceprevir, Bosentan,Carbamazepine, Carfilzomib, Clobazam,
Cobicistat, Colesevelam, strong CYP3A4 inducers, Dabrafenib, Elvitegravir, Enzalutamide, Eslicarbazepine,
Exenatide, Felbamate, Fosaprepitant, Fosphenytoin,Griseofulvin, Hyaluronidase, LamoTRIgine, Lesinurad,
Lixisenatide, Lomitapide, Lumacaftor, Mifepristone, Mitotane, Modafinil, Mycophenolate,Nafcillin, Nevirapine,
oxcarbazepine, Phenytoin,Pirfenidone, Pomalidomide, Protease Inhibitors, Prucalopride, Rifamycin Derivatives,
Rufinamide, Sugammadex, Telaprevir, Tipranavir, Topiramate, Vitamin K Antagonists
St. John’s Wort diminishes the efficacy of oral contraceptives, making conception a possibility.
DOSAGE & ADMINISTRATION: 4
Dose begins on first Sunday afteronset of menstruation; ifthe menstrual period starts on Sunday,take first tablet that very
same day.An additionalmethod ofcontraceptionshould be used until after the first 7 days of cons ecutive administration
Introvale,Jolessa,Quasense,Seasonale [Ethinylestradiol0.03 mg and levonorgestrel0.15 mg]: One active tablet/dayfor84
consecutive days,followed by 1 inactive tablet/day for7 days; if all doses have been taken on schedule and one menstrual
period is missed, pregnancy should be ruled out prior to continuing therapy.
Quartette,LoSeasonique. Seasonique[Ethinylestradiol0.03 mg and levonorgestrel0.15 mg and ethinyl estradiol 0.01 mg]:
One active tablet/dayfor84 consecutive days,followed by 1 low dose estrogentablet/dayfor7 days; ifall dos es havebeen
taken on schedule and one menstrual period is missed, pregnancy should be ruled out prior to continuing therapy.
Misseddoses:
One dose missed: Take as soon as remembered or take 2 tablets the next day
5. 5 | P a g e o f 6
Two consecutive dosesmissed:Take 2tablets as soonas remembered or2tablets the next 2days.An additionalnonhormonal
method of contraception should be used for 7 consecutive days after the missed dose.
Three or more consecutive doses missed:Do not take the missed doses; continue taking 1tablet/day untilpackis complete.
Bleeding may occurduring the following week. An additionalnonhormonalmethod of contraception should be used for7
consecutive days after the missed dose.
Any numberofpills during week 13: Throw away the missed pills and keep taking scheduled pills untilthe packis finished.
A back-up method of contraception is not needed
Renal Impairment Dose Adjustments: Specific guidelines not available; use with caution and monitorblood pressure closely.
Consider other forms of contraception
Hepatic Impairment Dose Adjustments: Contraindicated in hepatically-impaired patients
PRODUCT STORAGE: 4
Store at roomtemperature.
Store in a dry place. Do not store in a bathroomor in car.
Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
RISK MANAGEMENT: 4
Pregnancy Safety: Category X or contraindicated for use during pregnancy
Lactation: Jaundice and breastenlargement in the nursinginfant have beenreportedfollowing the use ofcombination hormonal
contraceptives. They may also decrease the quality and quantity of breast milk; the theoretical concerns about decreased milk
production are greatest early in the postpartum period when milk production is being established. Combined hormonal
contraceptives should not be started <21 days postpartumdue to increased risk of VTE.
PRODUCT AVAILABILITY: 4
Product comes in a 28-day and 91-day oraltablet package,patch,andvaginalring. Forthe purposes ofthis comparison,extended-
cycle pill forms will be compared.
DISTRIBUTION ISSUES: Amethia is scheduled to be discontinued by McKesson.9
RECOMMENDED MONITORING: 4
Before starting therapy,a physicalexam with reference to the breasts and pelvis are recommended, including a Pap smear.
Pregnancy should be ruled out prior to use.
Monitorpatient closely forloss ofvision,sudden onset ofproptosis,diplopia,migraine; blood pressure;signs and symptoms
of thromboembolic disorders; signsorsymptoms ofdepression; glycemic controlin patients with diabetes; lipid profiles in
patients being treated for hyperlipidemias.
COMPARABLE MEDICATIONS ON THE MARKET/COST COMPARISION: 9,10
Drug Name Package Size AWP Purchase Price
(Mckesson)
Unit Cost
Amethia 182 pills (X 1) $537.10 $391.44 $2.1508
Ashlyna 182 pills (X 1) $609.89 NOT AVAILABLE $3.35
Camrese 182 pills (X 1) $537.10 $116.46 $0.6399
Daysee 182 pills (X 1) $537.10 NOT AVAILABLE $2.95
Introvale 91 pills (X 1) $160.65 NOT AVAILABLE $1.76
Jolessa 91 pills (X 3) $482.02 $69.22 $0.2536
Quartette 91 pills (X 1) $422.02 $187.87 $2.0645
Quasense 91 pills (X 3) $482.09 $316.15 $1.1581
Seasonique 91 pills (X 1) $203.09 367.79 $2.0208
Setlakin 273 pills (X 1) $482.05 NOT AVAILABLE $1.76
6. 6 | P a g e o f 6
SOUND ALIKE/LOOK ALIKE NAMES:
Seasonique may be confused with seasonal allergies or Seasonale.4
CONCLUSION & FINAL RECOMMENDATION:
It is recommended to add an extended-cycle oralbirth controlforaddition to the formulary at the IHS Catawba Service Unit. Jolessa
would be appropriate due to its equivocal efficacy and safety profile in addition to its economical purchase price with McKesson.
Studies have shown thatnot only do a large fraction ofwomen wish to have less menstrualcycles throughoutthe year,but thatuse of
an extended-cycle regimen like Jolessa can provide decreased episodes ofpainfulmenstruation as well as less severe fluctuationsin
mood and depression. An extended-cycle birth controlalso provides benefit forpatients suffering frommenorrhagia, dysmenorrhea,
endometriosis,chronic pelvic pain,and anemia. Caution should be taken with women with a history ofclotting disorder; the riskis
no different than in monthly-cycle birth control. Because monthly-cycle birth control is already on formulary and extended-cycle
birth control poses no additional risks, it is fitting to add to the IHS Catawba Service Unit formulary.
REPORT PREPARED BY: Jade Abudia, PharmD Candidate 2017 on 21 October 2016
REFERENCES:
1. Kost K, Unintended PregnancyRates at the State Level:Estimates for 2010 and Trends Since 2002, New York:
Guttmacher Institute,2015.
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