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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 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4200

Last updated 2026-01-09

No results posted yet for this study

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

Interventions

BEHAVIORAL

Questionnaires

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

Sponsors & Collaborators

  • French Ministry of Social Affairs and Health

    collaborator UNKNOWN

  • University Hospital, Bordeaux

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2032-09-30
Completion
2032-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07330336 on ClinicalTrials.gov