Inducing labor at 39 weeks for low-risk first-time mothers to reduce cesarean rates
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)
This study is testing if starting labor at 39 weeks for first-time moms who are low-risk can help reduce the chances of needing a cesarean section.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 4200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 1 site (Bordeaux) |
| Trial ID | NCT04799912 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of elective labor induction at 39 weeks of gestation in low-risk nulliparous women compared to expectant management. The study aims to confirm findings from a previous trial in the U.S. that suggested labor induction could lower cesarean delivery rates without increasing adverse perinatal outcomes. Participants will be randomized to receive either labor induction or continue with expectant management, with outcomes measured to assess the frequency of cesarean deliveries and maternal complications. The trial is conducted in France and seeks to provide evidence for potential changes in clinical practice regarding labor induction.
Who should consider this trial
Good fit: Ideal candidates for this study are low-risk nulliparous women aged 18 and older, with a singleton pregnancy and a gestational age between 37 and 38 weeks.
Not a fit: Patients who are not nulliparous, have multiple pregnancies, or plan for cesarean delivery will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a reduction in cesarean deliveries among low-risk first-time mothers, improving maternal and neonatal health outcomes.
How similar studies have performed: Previous studies, such as the ARRIVE trial, have shown promising results with similar approaches, indicating a potential for success in this trial as well.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bordeaux
- CHU de Bordeaux — Bordeaux, France (Recruiting)
Study contacts
- Study coordinator: Loic Sentilhes, MD, PhD
- Email: loic.sentilhes@chu-bordeaux.fr
- Phone: +33556795579
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.