Status:
RECRUITING
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)
Lead Sponsor:
University Hospital, Bordeaux
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Cesarean Section
Eligibility:
FEMALE
18+ years
Phase:
NA
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...
Detailed Description
The nadir of the neonatal risks seems to be at 39 weeks of gestation and there is an augmentation of maternal complications after 39 weeks. Nonetheless, planned induction of labor at 39 weeks was not ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
4200 Patients enrolled
Trial Details
Trial ID
NCT04799912
Start Date
April 12 2021
End Date
June 1 2027
Last Update
February 11 2025
Active Locations (1)
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1
CHU de Bordeaux
Bordeaux, France