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)

NCT04799912 | Recruiting DMC

• 1 other identifier: CHUBX 2019/58
• Study Type: interventional
• Target: 4,200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cesarean Section

Keywords

Cesarean section; Labor induction; Expectant management; Low risk nulliparous women; Maternal morbidity; Neonatal morbidity

Outcome Measures

Primary Outcomes (1)

• Incidence of cesarean section

  Incidence of cesarean section defined as a cesarean birth regardless of the indication from the time the woman is randomized

  Day 1

Secondary Outcomes (31)

• Incidence of incisional extensions

  Day 1

• Incidence of operative vaginal delivery

  Day 1

• Incidence of operative vaginal delivery for cesarean

  Day 1

• Incidence of third or fourth degree perineal laceration

  Day 1

• Incidence of chorioamnionitis

  Hospital discharge (Day 3-5)

Study Arms (2)

Elective labor induction

EXPERIMENTAL

Elective labor induction via oxytocin between 39 weeks of gestation and 0 day and 39 weeks of gestation and 4 days for women with favorable cervix. Those with an unfavorable cervix (Bishop score \< 6) will first undergo cervical ripening (method left to the discretion of the practitioner) in conjunction with or followed by oxytocin stimulation unless a contraindication arises. Except for elective induction of labor between 39 weeks of gestation and 0 day and 39 weeks of gestation and 4 days, the obstetrical management will not be modified compared to routine obstetrical management.

Procedure: Elective labor induction

Expectant management

NO INTERVENTION

Standard follow-up visits until at least 41 weeks of gestation and 0 day without elective labor induction unless a medical indication is present. Antepartum fetal testing will be initiated no later than 41 weeks of gestation and 1 day according to policies at each center (according to the French guidelines). If still pregnant, all women will undergo induction since 41 weeks of gestation but no later than 42 weeks of gestation (according to the French guidelines)

Interventions

Elective labor induction PROCEDURE

Elective labor induction at 39 weeks of gestation

Elective labor induction

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify 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)
• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Ministry of Health, France: collaborator

Study Sites (1)

CHU de Bordeaux

Bordeaux, France

RECRUITING

Central Study Contacts

Loic Sentilhes, MD, PhD

CONTACT

+33556795579; loic.sentilhes@chu-bordeaux.fr

Hugo Madar, MD

CONTACT

hugo.madar@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter open randomized controlled trial with 2 parallel arms

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 16, 2021
• Study Start: April 12, 2021
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 11, 2025

Record last verified: 2025-02

Locations

FR (1)