5-Year checkup: does early labor induction affect child development?
NCT ID NCT07330336
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study follows 4200 mothers and their children for 5 years to see if inducing labor at 39 weeks (instead of waiting for natural labor) affects the child's brain development. Researchers will assess thinking, language, movement, and behavior skills. The goal is to help pregnant women make informed choices about timing of labor.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 4,200 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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5 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Women randomized in the FRENCH-ARRIVE trial (NCT04799912): * Age ≥ 18 years * Nulliparous women (i.e. no previous pregnancy beyond 20 weeks) * With singleton gestation. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks project gestational age. * Gestational age at randomization between 37 weeks of gestation 0 day and 38 weeks of gestation 6 days inclusive based on the crown rump length measured at the first trimester ultrasound before 14 weeks of gestation and 0 days, as recommended in France * Affiliated or beneficiary to a health security system * Signed informed consent * Non-opposition from both holders of parental authority to participation in the FAMILY-FA study Exclusion Criteria: * Exclusion criteria of the FRENCH-ARRIVE trial: * Project gestational age at date of first ultrasound is \> 14 weeks * Plan for induction of labor prior to 40 weeks 5 days * Plan for cesarean delivery or contraindication to labor * Breech presentation * Multiple pregnancy * Signs of labor (regular painful contractions with cervical change) * Fetal demise or known major fetal anomaly * Heparin or low-molecular weight heparin during the current pregnancy * Placenta previa, accreta, vasa previa * Active vaginal bleeding greater than bloody show * Ruptured membranes * Cerclage in current pregnancy * Known oligohydramnios, defined as Amniotic Fluid Index \< 5 or Maximal Vertical Pocket \< 2 cm * Fetal growth restriction, defined as Estimated Fetal Weight \< 10th percentile according to local curve * Known HIV positivity because of modified delivery plan * Major maternal medical illness associated with increased risk for adverse pregnancy outcome (for example, any diabetes mellitus, lupus, any hypertensive disorder, cardiac disease, renal insufficiency) * Refusal of blood products * Participation in another interventional study that may influence management of labor or delivery (labor induction, operative vaginal delivery, cesarean section, shoulder dystocia) * Delivery planned elsewhere at a non-Network site * History of myomectomy by laparotomy or laparoscopy * Previous metroplasty for uterine malformation or Asherman syndrome * Patient under legal protection * Poor understanding of the French language * Moreover: the following postnatal criteria will be also exclusion criteria: * Major malformations and/or chromosomal aberrations evidenced in the child after birth * Parents' refusal to participate in the follow-up * Impossibility to contact the family
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU Bordeaux
Bordeaux, France
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