Overview

Efficacy of 17 Alpha-hydroxyprogesterones Caproate for the Prevention of Preterm Delivery

Status:
Completed
Trial end date:
2010-05-01
Target enrollment:
Participant gender:
Summary
To demonstrate that the intramuscular administration of 17 alpha hydroxyprogesterones caproate allows to reduce the risk of preterm delivery, in 3 high risk populations defined by the association of an ultrasonographic cervical length egal and inferiority 26 mm between 20 and 32 weeks of gestation and: - either a first episode of preterm labor stopped by acute tocolysis; - either a history of late miscarriage or premature delivery or uterine malformation or DES - either a twin pregnancy. Therefore, a randomised, multicentre trial has been designed with initial stratification according to these three risk groups, opened with two parallel arms.
Phase:
Phase 4
Details
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Treatments:
11-hydroxyprogesterone
17 alpha-Hydroxyprogesterone Caproate
17-alpha-hydroxy-progesterone caproate