6-year Outcomes in Children After Nifedipine vs Placebo for Preterm Prelabor Rupture of Membranes at 22-33 Weeks

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

480 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-31

Study Completion Date

2034-09-30

Brief Summary

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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.

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Detailed Description

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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 risk of maternal infectious morbidity. In cases of early PPROM (22 to 33 completed weeks' gestation), expectant management is recommended in the absence of labor, chorioamnionitis or fetal distress. Antenatal steroids and antibiotics administration are recommended by international guidelines. However, there is no recommendation regarding tocolysis administration in the setting of PPROM. In theory, reducing uterine contractility should delay delivery and reduce the risks of prematurity and neonatal adverse consequences. Likewise, a prolongation of gestation may allow administering a corticosteroids complete course that is associated with a two-fold reduction of morbidity and mortality. However, tocolysis may prolong fetal exposure to inflammation and be associated with higher risk of materno-fetal infection, potentially associated with neonatal death or long-term sequelae, including cerebral palsy.

The investigators implemented the TOCOPROM randomized clinical trial to assess whether short-term (48 hr) tocolysis reduces perinatal morti-morbidity in cases of PPROM at 22-33 weeks. However, both short- and long-term outcomes should be taken into account to define the optimal treatment strategy. There are currently no data allowing to evaluate the impact of a short course of nifedipine versus placebo on neurodevelopmental outcomes in school-aged children born after PPROM. Therefore, following-up children born to mothers enrolled in the TOCOPROM trial, through a new study, the TOCOKIDS cohort, is a unique and timely opportunity to advance scientific knowledge and adapt clinical practices in France and worldwide.

The assessment at 6 years of age will consist in:

* A self-administered parental questionnaire, completed online or on paper
* Data collected from the health book, in particular the 6-year consultation
* A short psychological assessment (45 minutes), performed remotely by a psychologist through video conference.

Conditions

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Children Born to Mothers Enrolled in the TOCOPROM Trial

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Nifedipine

Exposure during pregnancy to Oral Nifedipine 20 mg LP (between 22 to 33 weeks of gestation): Loading dose at T0 and T0.5 (i.e. 30 min), total=2x20 mg Maintenance dose:

Oral Nifedipine 20 mg LP at T3, then 1 pill every 8 hours for 48 hours (i.e. T11, T19, T27, T35 and T43, total=6x20 mg)

Self-administered parental questionnaire

Intervention Type OTHER

A self-administered parental questionnaire, completed online or on paper, to assess different dimension of neurodevelopment

Placebo

Exposure during pregnancy to oral placebo of nifedipine (between 22 to 33 weeks of gestation) at T0, T0.5, T3, T11, T19, T27, T35 and T43

A short psychological assessment performed online

Intervention Type OTHER

NEMI-3: an intelligence test administered by a psychologist measuring a fluid and crystallised intelligence. The test consists of 117 spoken and visual questions, for a total administration time of 45 min. Results are expressed in the form of standard indices (mean 100, standard deviation 15) that facilitate comparisons with the results obtained on other intelligence scales.

Results will be classified as normal, mild delay (between 1 and \<2 standard deviation \[SD\] below the mean) or severe delay (≥2 SD).

Interventions

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Self-administered parental questionnaire

A self-administered parental questionnaire, completed online or on paper, to assess different dimension of neurodevelopment

Intervention Type OTHER

A short psychological assessment performed online

NEMI-3: an intelligence test administered by a psychologist measuring a fluid and crystallised intelligence. The test consists of 117 spoken and visual questions, for a total administration time of 45 min. Results are expressed in the form of standard indices (mean 100, standard deviation 15) that facilitate comparisons with the results obtained on other intelligence scales.

Results will be classified as normal, mild delay (between 1 and \<2 standard deviation \[SD\] below the mean) or severe delay (≥2 SD).

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

78 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilles KAYEM, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Université Paris Cité and Université Sorbonne Paris Nord, Paris, France. DHU Risks in Pregnancy, Paris Descartes University, Trousseau University Hospital