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Re: Cerclageand short cervixFrom: Andrew Folley (agfolley@hotmail.com)Wed Dec 17 11:53:28 2008
Results of Cochrane Collaboration review on cerclage and short cervix Main results Six trials with a total of 2175 women were analysed. Prophylactic cerclage was compared with no cerclage in four trials. There was no overall reduction in pregnancy loss and preterm delivery rates, although a small reduction in births under 33 weeks' gestation was seen in the largest trial (relative risks 0.75, 95% confidence interval 0.58 to 0.98). Cervical cerclage was associated with mild pyrexia, increased use of tocolytic therapy and hospital admissions but no serious morbidity. Two trials examined the role of therapeutic cerclage when ultrasound examination revealed short cervix. Pooled results failed to show a reduction in total pregnancy loss, early pregnancy loss or preterm delivery before 28 and 34 weeks in women assigned to cervical cerclage. Authors' conclusions Date: Wed, 17 Dec 2008 12:47:33 -0600From: agfolley@hotmail.comTo: ob-gyn-l@mail.obgyn.netSubject: RE: Progesterone and short cervix The Use of Progesterone for Prevention of Preterm Birth Abstract Objective: To introduce new information on the use of progesterone to prevent premature labour and to provide guidance to obstetrical caregivers who counsel women on the merits of this choice Options: This discussion is limited to progesterone therapy for prevention of preterm labour (PTL) in women at increased risk of PTL. Evidence: A search of both Medline and the Cochrane Library identified the most relevant medical evidence. This document represents an abstraction of the evidence rather than a methodological review. The level of evidence and quality of recommendations are described using the criteria and classifications of the Canadian Task Force on Preventive Health Care (Table 1). Values: This update is the consensus of the Maternal Fetal Medicine Committee of the Society of Obstetricians and Gynaecologists of Canada (SOGC). Benefits, Harms, and Costs: Counselling the patient at increased risk for PTL should include consideration of the potential benefits of progesterone use and our lack of/limited knowledge of many neonatal outcomes and optimal dosing. Sponsor: Society of Obstetricians and Gynaecologists of Canada. Recommendations 1. Women at risk for PTL should be encouraged to participate in studies on the role of progesterone in reducing the risks of preterm labour. (I-A) 2. Women should be informed about the lack of available data for many neonatal outcome variables and about the lack of comparative data on dosing and route of administration. Women with short cervix should be informed of the single large RCT showing the benefit of progesterone in preventing PTL. (I-A) 3. Women and their caregivers should be aware that a previous preterm labour and/or short cervix (< 15 mm at 22–26 weeks’ gestation) on transvaginal ultrasound could be used as an indication for progesterone therapy. The therapy should be started after 20 weeks’ gestation and stopped when the risk of prematurity is low. (I-A) 4. On the basis of the data from the RCTs and meta-analysis, it is recommended that in cases where the clinician and the patient have opted for the use of progesterone the following dosages should be used: • For prevention of PTL in women with history of previous PTL: 17 alpha- hydroxyprogesterone 250 mg IM weekly (IB) or progesterone 100 mg daily vaginally. (I-A) • For prevention of PTL in women with short cervix of 15 mm detected on transvaginal uktrasound at 22–26 weeks progesterone 200 mg daily vaginally. (I-A)J Obstet Gynaecol Can 2008;30(1):67–71 Date: Wed, 17 Dec 2008 12:43:18 -0600From: agfolley@hotmail.comTo: ob-gyn-l@mail.obgyn.netSubject: RE: Progesterone and short cervix Vaginal Progesterone Gel May Improve Infant Outcomes and Reduce the Rate of Preterm Birth in Women with a Short Cervix in Mid-Pregnancy LIVINGSTON, N.J.--(BUSINESS WIRE)--For the first time, data show a positive association between the use of vaginal progesterone and infants’ overall health at birth. Babies born to women with high-risk pregnancies treated with PROCHIEVE® 8% (progesterone gel) appear to be less likely to need intensive care than babies born to mothers treated with placebo, Columbia Laboratories, Inc. (NASDAQ:CBRX) announced today. The data are published in the October issue of Ultrasound in Obstetrics & Gynecology (also known as The White Journal), the official publication of the International Society of Ultrasound in Obstetrics and Gynecology. Researchers conducted a secondary analysis of phase III data from the largest-ever singleton preterm birth prevention study with progesterone looking specifically at a group of 46 women with high-risk pregnancies because they had a short cervix (less than 2.8 cm measured by trans-vaginal ultrasound). This analysis shows several statistically significant findings, including: Only one out of six (16%) newborns of mothers treated with vaginal progesterone gel needed to be admitted to neonatal intensive care units compared to one out of two (52%) newborns of mothers treated with placebo (p-value of 0.016); and Infants born to mothers treated with vaginal progesterone gel who were admitted to intensive care units spent on average only one day in intensive care compared to more than two weeks for those babies of mothers who received placebo (p-value of 0.013). This is the first and only preterm birth prevention study that is associated with statistically significant improvements in clinically important measures of infant outcomes. Additional studies are being planned to repeat this unique finding. In addition, the analysis provided new insight into which women with high-risk pregnancies respond to treatment with vaginal progesterone gel. It showed that treatment with vaginal progesterone gel may reduce early preterm birth among women with a short cervix. “When looking at a sample of 46 women with a short cervix of less than 2.8 cm, zero of those who were started on vaginal progesterone gel between 18-to-22 weeks of gestational age delivered prior to 32 weeks of gestation, while almost one in three women (29.6 percent; p=0.014) with a shortened cervix given a placebo delivered prior to 32 weeks of gestation,” said Emily DeFranco, DO, primary author of the study and clinical fellow of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, and Center for Preterm Birth Research at Washington University School of Medicine in St. Louis. “Additionally, the number of admissions and days spent in the neonatal intensive care unit, important measures of neonatal outcome, for babies whose moms were given vaginal progesterone gel were significantly lower than for those whose moms received placebo. We’re excited about these promising clinical implications, especially if confirmed in a larger study.” “Publishing these findings is an important step toward informing healthcare providers about the group of women who may benefit from vaginal progesterone by reducing their chances for hav ing an early preterm birth,” said study co-author John O’Brien, M.D., affiliated with Central Baptist Hospital, Lexington, KY. “There are currently no FDA-approved treatments available to help prevent preterm birth, so this research, combined with future studies, may lead to viable treatment options.” The published subset of data is from a randomized, double-blind, placebo-controlled study -- the largest study to date evaluating the effect of progesterone on early preterm birth in singletons. The report on these data, entitled “Vaginal Progesterone Is Associated With a Decrease in Risk for Early Preterm Birth and Improved Neonatal Outcome in Women with a Short Cervix,” is available at http://www3.interscience.wiley.com/cgi-bin/jhome/99020267. “Based on the statistically significant findings in the secondary analysis, we are moving forward with a follow-up study using PROCHIEVE 8%,” stated Robert S. Mills, president and chief executive officer of Columbia Laboratories. “It is estimated that of the more than 4.1 million live births in the U.S. each year, up to 30 percent of pregnant mothers have a cervical length less than or equal to 3.0 centimeters in mid-pregnancy. This includes many women with first-time pregnancies, the group that has the largest number of premature babies each year. We look forward to publishing the results of the next study.” A normal pregnancy is about 40 weeks. Preterm birth before 37 weeks gestation is a leading cause of infant and neonatal death, continues to rise, and occurs in more than 12 percent of pregnancies in the United States. The negative health effects of preterm birth go far beyond the first days of life; preterm birth is associated with a high prevalence of severe neurological deficits and devel as well. A 2005 March of Dimes study found that employers pay nearly 15 times more in direct healthcare coverage costs for babies born prematurely – in their first year of life – than for full term babies, with an average cost of $41,610 for a premature baby vs. $2,830 for a healthy, full-term baby. In a separate analysis, the March of Dimes estimates that in 2002, almost half of hospital charges for premature infants, or about $7.4 billion, were billed to employers and other private insurers. This estimate was derived using the Nationwide Inpatient Sample from the Agency for Healthcare Research and Quality. "Preterm birth has such a profound effect on both babies and their families that any research that can help us understand how to prevent preterm birth is a significant advance," said Susan Wysocki, RNC, NP, FAANP, president and chief executive officer National Association of Nurse Practitioners in Women's Health. The overall Phase III study, “Progesterone Vaginal Gel for the Reduction of Recurrent Preterm Birth: Primary Results from a Randomized, Double-blind, Placebo-controlled Trial,” did not show a beneficial effect of progesterone treatment on reducing the frequency of preterm birth in a larger population of high-risk women identified with “only” a history of spontaneous preterm birth. Progesterone is a natural hormone found in all women, though levels of progesterone increase during pregnancy. Progesterone is also a well-established hormonal supplement required for successful infertility treatments. About PROCHIEVE 8% PROCHIEVE® 8% is natural progesterone FDA-approved for progesterone supplementation or replacement as part of Assisted Reproductive Technology (ART) treatment for infertile women with progesterone deficiency. Several trials showing these benefits have been published. PROCHIEVE 8% is safe for use during pregnancy, and has been safely used for a decade by tens of thousands of women globally to help sustain pregnancy in the first trimester. Its unique bioadhesive delivery system provides controlled and sustained release of progesterone directly where it is needed. The most common side effects of PROCHIEVE 8% include breast enlargement, constipation, somnolence, nausea, headache, and perineal pain. PROCHIEVE 8% is contraindicated in patients with active thrombophlebitis or thromboembolic disorders, or a history of hormone-associated thrombophlebitis or thromboembolic disorders, missed abortion, undiagnosed vaginal bleeding, liver dysfunction or disease, and known or suspected malignancy of the breast or genital organs. For more information, please visit http://www.prochieve8.com. About Columbia Laboratories Columbia Laboratories, Inc. is a U.S.-based international pharmaceutical company dedicated to the development and commercialization of women’s healthcare and endocrinology products that use its novel bioadhesive drug delivery technology. Columbia markets CRINONE® 8% (progesterone gel) and PROCHIEVE® 8% (progesterone gel) in the United States for progesterone supplementation as part of Assisted Reproductive Technology treatment for infertile women with progesterone deficiency, and PROCHIEVE® 4% (progesterone gel) for the treatment of secondary amenorrhea. The Company also markets STRIANT® (testosterone buccal system) for the treatment of hypogonadism in men. For more information, please visit http://www.columbialabs.com. Date: Wed, 17 Dec 2008 12:38:04 -0600From: agfolley@hotmail.comTo: ob-gyn-l@mail.obgyn.netSubject: RE: Progesterone and short cervix Progesterone and the Risk of Preterm Birth among Women with a Short Cervix Eduardo B. Fonseca, M.D., Ebru Celik, M.D., Mauro Parra, M.D., Mandeep Singh, M.D., Kypros H. Nicolaides, M.D., for the Fetal Medicine Foundation Second Trimester Screening Group Abstract PDA Full Text PowerPoint Slide Set Editorial by Thornton, J. G. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation ABSTRACT Background Previous randomized trials have shown that progesterone administration in women who previously delivered prematurely reduces the risk of recurrent premature delivery. Asymptomatic women found at midgestation to have a short cervix are at greatly increased risk for spontaneous early preterm delivery, and it is unknown whether progesterone reduces this risk in such women. Methods Cervical length was measured by transvaginal ultrasonography at a median of 22 weeks of gestation (range, 20 to 25) in 24,620 pregnant women seen for routine prenatal care. Cervical length was 15 mm or less in 413 of the women (1.7%), and 250 (60.5%) of these 413 women were randomly assigned to receive vaginal progesterone (200 mg each night) or placebo from 24 to 34 weeks of gestation. The primary outcome was spontaneous delivery before 34 weeks. Results Spontaneous delivery before 34 weeks of gestation was less frequent in the progesterone group than in the placebo group (19.2% vs. 34.4%; relative risk, 0.56; 95% confidence interval [CI], 0.36 to 0.86). Progesterone was associated with a nonsignificant reduction in neonatal morbidity (8.1% vs. 13.8%; relative risk, 0.59; 95% CI, 0.26 to 1.25; P=0.17). There were no serious adverse events associated with the use of progesterone. Conclusions In women with a short cervix, treatment with progesterone reduces the rate of spontaneous early preterm delivery. (ClinicalTrials.gov number, NCT00422526 [ClinicalTrials.gov] .) Prematurity is the leading cause of neonatal death and handicap.1 Although all births before 37 weeks of gestation are defined as preterm, most damage and death occurs in infants delivered before 34 weeks.2,3 Improvements in neonatal care have led to higher rates of survival among very premature infants, but a major effect on the associated mortality and morbidity will be achieved only by better identification of women at high risk for preterm delivery and by development of an effective intervention to prevent this complication. The prophylactic administration of progesterone beginning in midgestation to women who previously had a preterm birth has been shown to halve the rate of recurrence.4,5,6 However, a strategy in which therapeutic intervention is limited to women with a previous preterm delivery is likely to have a small effect on the overall rate of prematurity, because only about 10% of spontaneous early preterm births occur in women with this history.7 A method that may better identify women at high risk with either singleton or twin pregnancies is ultrasonographic measurement of cervical length at 20 to 24 weeks of gestation.8,9,10 Asymptomatic women found to have a cervical length of 15 mm or less are at greatly increased risk for spontaneous early preterm delivery. We designed a multicenter, randomized trial to evaluate the effect of vaginal progesterone on the incidence of spontaneous early preterm delivery in asymptomatic women found at routine mid-trimester screening to have a short cervix. Date: Tue, 16 Dec 2008 11:45:51 -0600From: rd.braun@gmail.comTo: ob-gyn-l@mail.obgyn.netSubject: Re: Trouble with FP againI am giving GR in Dayton tomorrow. Topic: "Operative Vaginal Delivery". I may start by paraphrasing Antony.Friends Romans, Countrymen, I come to bury forceps, not to praise them.Dan On Tue, Dec 16, 2008 at 10:16 AM, <DoctorJoe@aol.com> wrote: In a message dated 12/16/08 9:09:59 AM, evsono@pipeline.com writes: In the US, Ob-Gyn's were trained to manage their own complications -bowel injuries, bladder injuries, etc. Over time, the medicolegalcancer spread insidiously so that consults are called routinely overthings well within the purview of a trained Ob-Gyn. Well, like most everything else, I wouldn't blame it ALL on the lawyers. They aren't that original. Much of the blame lies on our own organizatons, with the advent of specialization, limited residency experience, etc."We have met the enemy and he is us raun, MD FACOG(L) ABMP CMThProfessor EmeritusDept. of Obstetrics and GynecologyIndiana U. School of MedicineR. Daniel Braun "Science without Religion is LAME; Religion without Science is BLIND" Einstein 1941 Suspicious message? There’s an alert for that. Get your Hotmail® account now. Send e-mail anywhere. No map, no compass. Get your Hotmail® account now.. Suspicious message? There’s an alert for that. Get your Hotmail® account now. d_122008
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