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

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: 11-hydroxyprogesterone; 17 alpha-Hydroxyprogesterone Caproate; 17-alpha-hydroxy-progesterone caproate

Criteria

Inclusion Criteria:

• ultrasonographic cervical length 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.

Exclusion Criteria:

• cervical dilatation > 3 cm,

• chorioamnionitis,

• fetal distress,

• placenta praevia,

• abruptio placenta,

• preterm premature rupture of membranes,

• polyhydramnios,

• Twin-twin transfusion syndrome,

• IUGR,

• preeclampsia or hypertension,

• other pathology justifying a preterm delivery,

• epilepsy drugs

• participation to another therapeutic trial,

• any patient for whom informed consent cannot be obtained.