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NOT YET RECRUITING
NCT07330336
NA

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

Sponsor: University Hospital, Bordeaux

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

5 Years - Any

Study Type

INTERVENTIONAL

Enrollment

4200

Start Date

2026-04

Completion Date

2032-09

Last Updated

2026-01-09

Healthy Volunteers

No

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

Locations (1)

CHU Bordeaux

Bordeaux, France