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Vaginal progesterone gel may improve infant outcomes and...
Date:10/2/2007

ogesterone 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. Were 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 having an early preterm birth, said study co-author John OBrien, 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

Contact: Kathleen Cosgrove
kathleen.cosgrove@mslpr.com
617-937-2534
Columbia Laboratories, Inc.
Source:Eurekalert

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