Labor Induction in Low-risk Nulliparous Women at 39 Weeks of Gestation to Reduce Cesarean: A Randomized Trial of Induction Versus Expectant Management in France (FRENCH-ARRIVE)
Recruiting now · Not applicable
Conditions studied: Cesarean Section
In brief
The recent ARRIVE trial conducted in United States of America in 2014-2017 demonstrates that elective induction of labor at 39 weeks for nulliparous women did result in a significantly lower frequency of cesarean delivery with no significant differences of adverse perinatal outcomes. But the expected benefits of elective labor induction at 39 weeks have to be confirmed in other settings outside US before considering routine induction of labor for all low-risk nulliparous women at 39 weeks of gestation worldwide.
Key facts
- Study ID
- NCT04799912
- Run by
- University Hospital, Bordeaux
- People needed
- 4200
- Starts
- 2021-04-12
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2025-02-11
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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 day, as recommended in France
- Affiliated or beneficiary to a health security system
- Signed informed consent
You may not qualify if…
- Project gestational age at date of first ultrasound > 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
- Contraindication to oxytocin
- Participation in another interventional study that influences 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
Where it is running
- CHU de Bordeaux — Bordeaux, France (enrolling)
Full record on ClinicalTrials.gov
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