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

NCT00331695 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 560

Last updated 2011-05-09

No results posted yet for this study

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.

Conditions

  • Preterm Delivery

Interventions

DRUG

17 alpha-hydroxyprogesterones caproate

17 alpha-hydroxyprogesterones caproate

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Patrick ROZENBERG, MD, · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00331695 on ClinicalTrials.gov