NCT07146451 6-year Outcomes in Children After Nifedipine vs Placebo for Preterm Prelabor Rupture of Membranes at 22-33 Weeks
| NCT ID | NCT07146451 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Children Born to Mothers Enrolled in the TOCOPROM Trial |
| Study Type | OBSERVATIONAL |
| Enrollment | 480 participants |
| Start Date | 2025-10-28 |
| Primary Completion | 2033-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 480 participants in total. It began in 2025-10-28 with a primary completion date of 2033-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 nifedipine vs placebo.
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 the psychological evaluation) * Non opposition of the holders of the exercise of parental authority Exclusion Criteria: * Major malformations and/or chromosomal aberrations evidenced after birth * Impossibility to contact the family * Opposition to participate in the follow-up
Contact & Investigator
Gilles KAYEM, MD,PhD
PRINCIPAL INVESTIGATOR
Université Paris Cité and Université Sorbonne Paris Nord, Paris, France. DHU Risks in Pregnancy, Paris Descartes University, Trousseau University Hospital
Frequently Asked Questions
Who can join the NCT07146451 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 78 Months, studying Children Born to Mothers Enrolled in the TOCOPROM Trial. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07146451 currently recruiting?
Yes, NCT07146451 is actively recruiting participants. Contact the research team at gilles.kayem@aphp.fr for enrollment information.
Where is the NCT07146451 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT07146451 clinical trial?
NCT07146451 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Gilles KAYEM, MD,PhD at Université Paris Cité and Université Sorbonne Paris Nord, Paris, France. DHU Risks in Pregnancy, Paris Descartes University, Trousseau University Hospital. The trial plans to enroll 480 participants.