Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
NCT ID:
NCT04799912
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04799912
Study Brief:
Protocol Section:
NCT04799912