NCT00536003

Vaginal Progesterone to Prevent Preterm Delivery in Women With Preterm Labor

Prevention of Preterm Delivery With Vaginal Progesterone in Women With Preterm Labor

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 384 (actual)
• Sponsor: begoña Martinez de Tejada · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Preterm Delivery
• Morbidity
• Perinatal Mortality

Interventions

Type	Name	Description
DRUG	progesterone	vaginal capsules containing 200 mg of natural progesterone, once a day, until 36 6/7 weeks of gestation or until preterm delivery (whichever occurs first).
DRUG	placebo	vaginal capsules containing placebo, once a day, until 36 6/7 weeks of gestation or until preterm delivery (whichever occurs first).

Timeline

• Start date: 2006-07-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2007-09-27
• Last updated: 2012-06-06

Locations

33 sites across 2 countries: Argentina, Switzerland