Clinical Trial: Vaginal Progesterone to Prevent Preterm Delivery in Women With Preterm Labor

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Prevention of Preterm Delivery With Vaginal Progesterone in Women With Preterm Labor

Brief Summary: The administration of vaginal progesterone, in addition to standard tocolysis, will decrease the risk of delivering prematurely and of recurrent preterm labor. We also hypothesize that the reduction in preterm delivery will be associated with a decrease in infant mortality and morbidity.

Detailed Summary: The principal aim is to demonstrate that progesterone reduces preterm birth before 37 weeks of gestation. Secondary aims are to show that progesterone 1) reduces preterm birth before 32 and before 34 weeks of gestation 2) reduces the number and duration of recurring episodes of preterm labor and 3) reduces infant mortality and morbidity.
Sponsor: begoña Martinez de Tejada

Current Primary Outcome: The principal aim is to demonstrate that progesterone reduces preterm birth before 37 weeks of gestation [ Time Frame: end of pregnancy ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Secondary aims are to show that progesterone 1) reduces preterm birth before 32 and before 34 weeks of gestation 2) reduces the number and duration of recurring episodes of preterm labor and 3) reduces perinatal mortality and morbidity, 4)Side effects [ Time Frame: end of pregnancy and 28 days after delivery ]

Original Secondary Outcome: Secondary aims are to show that progesterone 1) reduces preterm birth before 32 and before 34 weeks of gestation 2) reduces the number and duration of recurring episodes of preterm labor and 3) reduces perinatal mortality and morbidity. [ Time Frame: end of pregnancy and 28 days after delivery ]

Information By: University Hospital, Geneva

Dates:
Date Received: September 24, 2007
Date Started: July 2006
Date Completion: December 2012
Last Updated: June 5, 2012
Last Verified: June 2012