5-Year Follow-up of Children and Mother After Expectant Management Versus Induction of Labor in Low-risk Nulliparous Women at 39 Weeks of Gestation

NCT07330336 | Not Yet Recruiting

• 1 other identifier: CHUBX 2024/46
• Study Type: interventional
• Target: 4,200
• Locations: 1 country
• Sites: 1

Brief Summary

In France, the rate of labor induction has markedly increased in recent years, partly following the ARRIVE trial suggesting short-term benefits of elective induction at 39 weeks in low-risk nulliparous women. This trial is currently being replicated in France (FRENCH-ARRIVE), as maternal characteristics, cesarean rates, and healthcare organization differ from the US. Importantly, no comparative data exist on the mid-term consequences of reducing gestational age at delivery with elective induction of labor-from 41 to 39 weeks-versus usual expectant management on child health and maternal outcomes. Generating such evidence is essential to inform decision making for women reaching 39 weeks of gestation, i.e. the large majority of pregnant women

Conditions

Neurodevelopmental Disorders

Keywords

Child neurodevelopmental disorder; pregnancy; Low-risk nulliparous women; induction of labor; elective; cesarean delivery; maternal mental health; postpartum; depression

Outcome Measures

Primary Outcomes (1)

• pediatric neurodevelopment at 5 years of age

  pediatric neurodevelopment at 5 years of age, based on the assessment of different dimensions (development, motor, coordination, neurosensory, language, and behavior and executive functions). The Ages and Stages Questionnaire (ASQ-3) and the preschool version of the Child Behavior Checklist (CBCL 1½-5). The scales will be analyzed quantitatively, and the extreme values of the scores obtained will be considered pathological (≥2SD below mean or \<83th percentile, depending on the scale) according to the literature

  5 years old

Secondary Outcomes (7)

• Child neurodevelopment

  5 years old

• Child cognition

  5 years old

• Maternal depression

  Baseline

• Maternal anxiety

  Baseline

• Maternal partner relationship satisfaction

  Baseline

Study Arms (2)

elective induction arm

EXPERIMENTAL

elective induction

Behavioral: Questionnaires

expectant management arm

ACTIVE COMPARATOR

expectant management

Behavioral: Questionnaires

Interventions

Questionnaires BEHAVIORAL

self-administered parental and teacher questionnaires 5 years after the birth of the first child (i.e., 5 years after enrollment in the FRENCH-ARRIVE trial). In addition, for a randomly selected subsample of 12% of participants (n=500), a brief neuropsychological assessment of their child (\~1 hour) will be conducted remotely via videoconference by a trained neuropsychologist

elective induction arm; expectant management arm

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women randomized in the FRENCH-ARRIVE trial (NCT04799912):
• 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 days, as recommended in France
• Affiliated or beneficiary to a health security system
• Signed informed consent
• Non-opposition from both holders of parental authority to participation in the FAMILY-FA study

You may not qualify if:

• Project gestational age at date of first ultrasound is \> 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
• French Ministry of Social Affairs and Health: collaborator

Study Sites (1)

CHU Bordeaux

Bordeaux, France

Location

MeSH Terms

Conditions

Neurodevelopmental Disorders; Depression

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Loïc Sentilhes, MD, PhD

CONTACT

+33 5 56 79 55 79; loic.sentilhes@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

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 9, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 1, 2032
• Study Completion (Estimated): September 1, 2032
• Last Updated: January 9, 2026

Record last verified: 2025-12

Locations

FR (1)