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Asymptomatic short cervix and vaginanal, progesterone
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Asymptomatic short cervix and vaginanal, progesterone

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  • 1. Vaginal Progesterone In Women With An Asymptomatic Sonographic Short Cervix InThe Midtrimester Decreases Preterm DeliveryAnd Neonatal Morbidity: A Systematic ReviewAnd Meta-Analysis Of Individual Patient DataRoberto Romero, MD, Kypros Nicolaides, etal. American Journal of Obstetrics and Gynecology (2011), doi: 10.1016/j.ajog.2011.12.003. The meta- analysis is now available via open access at http://www.ajog.org/article/S0002-9378(11)02358-1/abstract, and will be published in the American Journal of Obstetrics and Gynecology, the journal of the Society for Maternal-Fetal Medicine (SMFM).
  • 2. VAGINAL PROGESTERONE ( 8% GEL OR; 90-100 MG MICRONIZED CAPSULE OR PROGESTERONE PESSARY) ONCE/DAILY FROM MIDTRIMRETSER IDENTFICATION OF ASYMPTOMATIC CERCICAL SHORTENING < 25MM. TRTEATMENT FROM IDENTIFICATION UNTIL 37 WEEKS, DECRESES PRETERM BIRTH < 33 WEEKS BY 45 % AND DECREASES NEONATLAL MORBIDITY AND MORTALITY• Roberto Romero, M.D., Chief of the Perinatology Research Branch (PRB) of the Division of Intramural Research of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH), was the Principal Investigator of the meta-analysis, which evaluated the efficacy and safety of vaginal progesterone for the prevention of preterm birth and neonatal morbidity and mortality in asymptomatic women with a sonographic short cervix (≤25 mm) in the mid-trimester of pregnancy. This double-blind, placebo controlled study evaluated a total of 775 women and 827 infants. Women between the ages of 15 and 45 at more than 40 sites in 10 countries were evaluated.• Treatment with vaginal progesterone was associated with a significant reduction in the rate of preterm birth at <33 weeks, <35 weeks and <28 weeks,• COMPOSITE NEONATAL MORBIDITY AND MORTALITY was also significantly reduced specifically:1. respiratory distress syndrome,2. birth weight <1500 g, admission to NICU,3. and requirement for mechanical ventilation.• There were no significant differences between the vaginal progesterone and placebo groups in the rate of adverse maternal events or congenital anomalies
  • 3. Results not applicable to all patientsTrials were included if the primary aim of the study was to prevent preterm birth in women with a short cervix, or if the primary aim was to prevent preterm birth in women with risk factors other than a short cervix, but outcomes were available for patients with a pre-randomization cervical length of 25 mm or less.Trials were excluded if they:1. Women with actual or threatened preterm labor, second trimester bleeding or premature rupture of membranes were excluded;2. evaluated the administration of vaginal progesterone in the first trimester only to prevent miscarriage;3. Of interest twins were included and demonstrated improved outcomes.4. Of further interest women without a previous preterm delivery were included also demonstrated improved outcome.Although there is no agreement on what is a sonographic short cervix, we chose 25 mm as the cutoff because this value corresponds approximately to the 10th percentile for cervical length in the midtrimester.10
  • 4. SIGNIGIFICANT OUTCOMES• Treatment with vaginal progesterone ONCE/DAY was associated with a significant reduction in the rate of preterm birth1. <28 weeks (RR 0.50, 95% CI 0.30-0.81)2. <33 weeks (RR 0.58, 95% CI 0.42-0.80),3. <35 weeks (RR 0.69, 95% CI 0.55-0.88)• TREATMENT WITH VAGIANL PROGESETERONE WAS ALSO ASSOCAITED WITH A SIGNIFICANT REDUCTION IN THE RATE OF COMPSOTIE NEONATAL MORBIDITY AND MORTALITY• (RR 0.57, 95% CI 0.40-0.81)• SPECFIC MEASURES OF MORBIDITY INCLUDED1. respiratory distress syndrome (RR 0.48, 95% CI 0.30-0.76)2. birth weight <1500 g (RR 0.55, 95% CI 0.38-0.80),3. admission to NICU (RR 0.75, 95% CI 0.59-0.94),4. and requirement for mechanical ventilation (RR 0.66, 95% CI 0.44-0.98).• There were no significant differences between the vaginal progesterone and placebo groups in the rate of adverse maternal events or congenital anomalies.
  • 5. Reminiscent of McKenna 17P PROPREITARY FORMULATION RECOMMENDATIONS PENDING FROM SMFM / ACOG / NIHSEVERAL OTHER PROGESTEREONE PRODUCTS WERE UTILIZED IN THE STUDY :( 8% VAGINAL GEL / 90-100 MILLIGRAMS VAGINAL CAPSULES / AND VAGINAL PESSARIES/ AS WELL AS 200 MILLLIGRAMS VAGINAL TABLETS WITH NO ADVANTAGE ATTRIBUTABLE TO EITHER PRODUCT OR DOSE• Columbia Laboratories, Inc. is developing products that utilize its novel bioadhesive drug delivery technologies to optimize drug delivery in a controlled, sustained manner.• The Company has developed and sold six products for the U.S. market including CRINONE® (progesterone gel), for which Columbia receives royalties on annual net sales from Watson Pharmaceuticals.• CRINONE is commercialized outside the U.S. by Merck Serono.• The Company’s New Drug Application (NDA) for progesterone vaginal gel 8% for the reduction of risk of preterm birth in women with a singleton gestation and a short uterine cervical length in the mid-trimester of pregnancy was accepted for filing by the Food and Drug Administration (FDA) with a PDUFA date of February 26, 2012.• The NDA is scheduled to be discussed by the Advisory Committee for Reproductive Health Drugs of the FDA on January 20, 2012.
  • 6. Proprietary 8% gel PROCHIEVE®• No obvious advantage demonstrated with outcomes associated with the proprietary product except patient convenience?? There in my opinion no controversy aas what to use.• PROCHIEVE® 8% (progesterone gel) is a bio adhesive product that utilizes Columbia’s proprietary Bio adhesive Delivery System (BDS) to deliver natural progesterone vaginally in a convenient and patient-friendly, pre-filled, tampon-like applicator.• By using a non-immunogenic (hypo-allergenic) bio adhesive polymer designed to adhere to the vaginal tissue, PROCHIEVE 8% promotes controlled and sustained absorption of progesterone and minimizes leakage, a side effect commonly seen with vaginal suppositories.• As a result, the product does not restrict normal activities.
  • 7. UNTIL OFFICIAL RECOMMENDATION from SMFM / ACOG / NIH states otherwise RIVERSIDE RECOMMENDATION• FOR ASYMTOMATIC WOMEN NOTED TO HAVE SHORT CERIX < 25 MM IN THE SECOND TRIMESTER (INCLUDING TWINS AND PT WITH NO PREVIOUS ptd )• TREAT WITH 90-100 milligrams micronized vaginal suppository ONCE DALY UNTIL 36 COMPLTED WEEKS