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)

Launched by UNIVERSITY HOSPITAL, BORDEAUX · Mar 12, 2021

Keywords

ClinConnect Summary

The FRENCH-ARRIVE clinical trial is studying whether inducing labor at 39 weeks of pregnancy can help reduce the number of cesarean deliveries in low-risk first-time mothers (women who have never given birth before). Previous research in the United States showed that this approach might lower cesarean rates without causing harm to the baby. Now, this trial aims to see if these results hold true in France, as it’s important to confirm benefits in different regions before making changes to standard practices worldwide.

To participate in this trial, women must be at least 18 years old, be having their first baby, and be between 38 weeks and 39 weeks of pregnancy. They also need to be part of a health insurance system and agree to take part by signing a consent form. Participants will be randomly assigned to either have their labor induced or to wait for labor to start on its own. This study will help us understand if the benefits seen in previous trials can be replicated in a different setting, which could influence how healthcare providers manage labor for first-time mothers in the future.

Gender

FEMALE

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