5-Year Follow-up of Children and Mother After Expectant Management Versus Induction of Labor in L… (NCT07330336) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
5-Year Follow-up of Children and Mother After Expectant Management Versus Induction of Labor in Low-risk Nulliparous Women at 39 Weeks of Gestation
France4,200 participantsStarted 2026-04
Plain-language summary
In France, the rate of labor induction has markedly increased in recent years, partly following the ARRIVE trial suggesting short-term benefits of elective induction at 39 weeks in low-risk nulliparous women. This trial is currently being replicated in France (FRENCH-ARRIVE), as maternal characteristics, cesarean rates, and healthcare organization differ from the US. Importantly, no comparative data exist on the mid-term consequences of reducing gestational age at delivery with elective induction of labor-from 41 to 39 weeks-versus usual expectant management on child health and maternal outcomes. Generating such evidence is essential to inform decision making for women reaching 39 weeks of gestation, i.e. the large majority of pregnant women
Who can participate
Age range
5 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 F…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is following up children at 5 years old to assess neurodevelopment after either expectant management or induced labor at 39 weeks — does my child qualify for this kind of follow-up study, and would my doctor think it's worth participating in once it opens?
2Since this study is not yet recruiting, how long might it realistically be before enrollment begins, and is there anything I should be doing in the meantime to track my child's developmental milestones?
3The original trial compared waiting versus inducing labor at 39 weeks — based on my own delivery circumstances, which group would my child likely fall into, and does my doctor think that distinction matters for interpreting any findings from this follow-up?
4What does 'neurodevelopmental assessment at 5 years' actually involve in a study like this — what kinds of tests or evaluations would my child go through, and how demanding would participation be for our family?
5Are there already any published results from the original 39-week induction versus expectant management trial that my doctor thinks are relevant to my child's development now, while we wait for this longer-term follow-up data?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.