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

NCT05439733 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 16800

Last updated 2023-06-15

No results posted yet for this study

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.

Conditions

  • Scarred Uterus

Interventions

OTHER

Questionnaire completion

Women will be asked to complete questionnaires 6 weeks after delivery

Sponsors & Collaborators

  • Assistance Publique Hopitaux De Marseille

    lead OTHER

Principal Investigators

  • François CREMIEUX · ASSITANCE PUBLIQUE HOPITAUX MARSEILLE

  • Julie BLANC · ASSITANCE PUBLIQUE HOPITAUX MARSEILLE

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-02
Primary Completion
2025-01-31
Completion
2025-07-31

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 NCT05439733 on ClinicalTrials.gov