Status:
COMPLETED
Efficacy of 17 Alpha-hydroxyprogesterones Caproate for the Prevention of Preterm Delivery
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Preterm Delivery
Eligibility:
FEMALE
18-49 years
Phase:
PHASE4
Brief 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 a...
Detailed Description
Objective 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 ass...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
560 Patients enrolled
Trial Details
Trial ID
NCT00331695
Start Date
June 1 2006
End Date
May 1 2010
Last Update
May 9 2011
Active Locations (2)
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1
CHI Poissy st Germain
Poissy, France, 78303
2
Chi Poissy St Germain
Poissy, France, 78