Status:
NOT_YET_RECRUITING
6-year Outcomes in Children After Nifedipine vs Placebo for Preterm Prelabor Rupture of Membranes at 22-33 Weeks
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Children Born to Mothers Enrolled in the TOCOPROM Trial
Eligibility:
All Genders
6-78 years
Brief Summary
The purpose of this study is to evaluate the neurodevelopment at age 6 of children born to women with preterm prelabor rupture of membranes at 22 to 33 weeks of gestation, after antenatal exposure to ...
Detailed Description
Preterm prelabor rupture of membranes (PPROM) complicates 3% of pregnancies and accounts for one-third of preterm births. It is a leading cause of neonatal mortality and morbidity and increases the ri...
Eligibility Criteria
Inclusion
- All children born to mothers enrolled in the TOCOPROM trial who consented to participate in the 2-year follow-up and who agreed to be contacted for the 6-year follow-up
- Alive at 6 years
- Internet access, including access to a good-quality video-conference system (only for the psychological evaluation)
- Non opposition of the holders of the exercise of parental authority
Exclusion
- Major malformations and/or chromosomal aberrations evidenced after birth
- Impossibility to contact the family
- Opposition to participate in the follow-up
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2034
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT07146451
Start Date
October 1 2025
End Date
September 1 2034
Last Update
August 28 2025
Active Locations (1)
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1
Trousseau University Hospital
Paris, France, France, 75012