Inducing labor at 39 weeks for low-risk first-time mothers to reduce cesarean rates

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• CHU de Bordeaux
  Bordeaux, France Recruiting

Study contacts

• Study coordinator: Loic Sentilhes, MD, PhD
• Email: loic.sentilhes@chu-bordeaux.fr
• Phone: +33556795579

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.