6-year Outcomes in Children After Nifedipine vs Placebo for Preterm Prelabor Rupture of Membranes at 22-33 Weeks
Recruiting
Observational Study
Children Born to Mothers Enrolled in the TOCOPROM Trial
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 6 – 78 Months
- Sex
- Any
- Study type
- Observational
- Participants needed
- 480 (estimated)
- Sponsor
- Assistance Publique - Hôpitaux de Paris · Other
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About This Trial
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 t…
Contacts