An interventional study of Vaginal progesterone gel and Placebo vaginal gel in Labor, Premature, sponsored by University of Rochester. Withdrawn at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-10-01.
Sponsored by University of Rochester · Not applicable, Interventional, and Treatment
The purpose of this study is to compare how well vaginal progesterone works delaying the time to delivery in women with preterm labor compared to placebo. The study will also compare the effect of vaginal progesterone on neonatal outcomes, rate of spontaneous preterm delivery, cervical length and biomarkers of preterm delivery in women diagnosed with and treated with medication to stop preterm labor.
Preterm birth remains a leading cause of perinatal mortality and morbidity. Despite advances in obstetric and pediatric care, the incidence of preterm birth has increased by more than 20% in the last two decades. Approximately 12.8% of births are preterm, however these account for more than 75% of all perinatal morbidity and mortality. Currently prophylactic progesterone administration is the most effective method available for the prevention of recurrent preterm birth. Prior studies have examined the impact of progesterone in women with recurrent preterm birth and cervical shortening. The possible use of progesterone in women experiencing active preterm labor may address the highest risk condition, however, there have not been any clinical trials to date examining this use of vaginal progesterone. Inflammation and decidual hemorrhage are among the proposed mechanisms that appear to be related to preterm labor.We will use a double blinded randomized drug placebo design to study the proposed outcomes in women diagnosed with preterm labor and planned to have standard of care tocolytic therapy. Women will be randomized to daily vaginal progesterone gel or placebo and will be maintained on the drug or placebo until delivery or 36 6/7 weeks.
261 studies on the registry are indexed under Obstetric Labor, Premature; 38 are open to participants now.
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Exclusion Criteria:
Drug: Vaginal progesterone gel
Drug: Placebo vaginal gel
Subjects will receive daily vaginal progesterone gel provided by Columbia laboratories (1.125g progesterone gel containing 90mg (8%) progesterone)
Also known as: Prochieve® 8%/Crinone 8%®
Subjects will receive daily placebo vaginal gel, made of an identical bioadhesive delivery system as the active drug
Also known as: Replens®
Latency to delivery
Time frame: Time in days from randomization day to day of end of pregnancy
Cervical length
Time frame: within 24 hours of first tocolytic dose and at first week follow up
Delivery prior to 37, 34 and 32 weeks
Time frame: after delivery
Number of subsequent hospital admissions for preterm labor
Time frame: after delivery
This study is withdrawn, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Progesterone