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 range5 Years
SexALL
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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…