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

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

Conditions: Children Born to Mothers Enrolled in the TOCOPROM Trial

Treatments: Other: Self-administered parental questionnaire; Other: A short psychological assessment performed online

Study type: Observational

Funder types: Other

Identifiers

NCT07146451

APHP230846

Details and patient eligibility

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.

Full 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 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.

Enrollment: 480 estimated patients

Sex: All

Ages: 6 years to 78 months old

Volunteers: No Healthy Volunteers

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

Trial design

480 participants in 2 patient groups

Nifedipine

Description:

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)

Treatment:

Other: Self-administered parental questionnaire

Placebo

Description:

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

Treatment:

Other: A short psychological assessment performed online