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COMPLETED
NCT05439733

Planned Mode of Delivery After Caesarean: a Comparative Prospective National Population-based Cohort Study

Sponsor: Assistance Publique Hopitaux De Marseille

View on ClinicalTrials.gov

Summary

In women with one previous caesarean, the choice of mode of delivery is determined by a shared decision-making process between the women and the obstetrician, with the two options being a trial of labour after caesarean (TOLAC) or an elective repeat caesarean delivery (ERCD). To date, the scientific literature has reported of higher perinatal morbidity-mortality with TOLAC, although with low absolute risks and discordant results about maternal morbidity-mortality. These studies suffer from limitations, as they include women with more than one previous caesarean or with high rates of failed TOLAC, which are two risk factors for uterine rupture, and the definition of planned versus effective mode of delivery is not precise in most studies. However, scientific societies recommend that most women with one previous caesarean should be offered TOLAC because of the low absolute perinatal risk of this option and the high maternal and perinatal risk associated with an ERCD in the short- and long-term. Conversely, the investigators hypothesise that TOLAC would be not inferior to ERCD in women with one previous caesarean in terms of perinatal morbidity-mortality.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

16764

Start Date

2023-06-22

Completion Date

2026-01-13

Last Updated

2026-08-03

Healthy Volunteers

No

Conditions

Interventions

OTHER

Questionnaire completion

Women will be asked to complete questionnaires 6 weeks after delivery

Locations (1)

Assistance Publique Hôpitaux Marseille

Marseille, Bouches-du-rhône, France