Actively Recruiting
6-year Outcomes in Children After Nifedipine vs Placebo for Preterm Prelabor Rupture of Membranes at 22-33 Weeks
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-02-13
480
Participants Needed
1
Research Sites
461 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
U
URC-CIC Paris Descartes Necker Cochin
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 nifedipine vs placebo.
CONDITIONS
Official Title
6-year Outcomes in Children After Nifedipine vs Placebo for Preterm Prelabor Rupture of Membranes at 22-33 Weeks
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Child born to a mother enrolled in the TOCOPROM trial who consented to the 2-year follow-up and agreed to be contacted for the 6-year follow-up
- Child is alive at 6 years of age
- Access to the internet and a good-quality video-conference system (for psychological evaluation)
- No opposition from legal holders of parental authority
You will not qualify if you...
- Major malformations or chromosomal abnormalities identified after birth
- Unable to contact the family
- Opposition to participate in the follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Trousseau University Hospital
Paris, France, France, 75012
Actively Recruiting
Research Team
G
Gilles KAYEM, MD,PhD
CONTACT
N
Nelly Briand, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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