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Vaginal Progesterone to Prevent Preterm Delivery in Women With Preterm Labor — 4P  

Morbidity Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00536003
Study type Interventional
Source University Hospital, Geneva
Contact
Status Terminated
Phase Phase 3
Start date July 2006
Completion date December 2012
View Details
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