NCT04799912 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)
| NCT ID | NCT04799912 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Bordeaux |
| Condition | Cesarean Section |
| Study Type | INTERVENTIONAL |
| Enrollment | 4,200 participants |
| Start Date | 2021-04-12 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 4,200 participants in total. It began in 2021-04-12 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04799912 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Cesarean Section. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04799912 currently recruiting?
Yes, NCT04799912 is actively recruiting participants. Contact the research team at loic.sentilhes@chu-bordeaux.fr for enrollment information.
Where is the NCT04799912 trial being conducted?
This trial is being conducted at Bordeaux, France.
Who is sponsoring the NCT04799912 clinical trial?
NCT04799912 is sponsored by University Hospital, Bordeaux. The trial plans to enroll 4,200 participants.