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Compares treatment options for Cesarean Section
Official title 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)
ClinicalTrials.gov ID: NCT04799912
What this study is testing
- What it's testing
- 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 of cesarean delivery with no significant differences of adverse perinatal outcomes. But the expected benefits of elective labor induction at 39 weeks have to be confirmed in other settings outside US before considering routine induction of labor for all low-risk nulliparous women at 39 weeks of gestation worldwide.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
- 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...
- Affiliated or beneficiary to a health security system
You likely can't join if
- 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)
See the full eligibility 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...
- Affiliated or beneficiary to a health security system
- Signed informed consent
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.