Comparing delivery options for women with one previous caesarean
Planned Mode of Delivery After Caesarean: a Comparative Prospective National Population-based Cohort Study
This study is testing whether trying to have a vaginal birth after a previous caesarean is as safe as having another caesarean for women who have had one prior surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 16800 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Assistance Publique Hopitaux De Marseille Academic / other |
| Locations | 1 site (Marseille, Bouches-du-rhône) |
| Trial ID | NCT05439733 on ClinicalTrials.gov |
What this trial studies
This observational cohort study evaluates the safety and outcomes of two delivery options for women with one previous caesarean: trial of labour after caesarean (TOLAC) and elective repeat caesarean delivery (ERCD). The study aims to determine if TOLAC is non-inferior to ERCD in terms of perinatal morbidity and mortality rates. Additionally, it will assess various maternal and infant health outcomes, including satisfaction, quality of life, and the risk of postnatal depression. Data will be collected through questionnaires and follow-ups at multiple time points postpartum.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18 or older, with a singleton pregnancy and one previous caesarean delivery, who are admitted to the labour ward at 34 weeks gestation or later.
Not a fit: Patients who have multiple pregnancies, more than one previous caesarean, or those who do not understand French may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence to support safer delivery options for women with a history of caesarean, potentially reducing risks associated with repeat surgeries.
How similar studies have performed: Previous studies have shown mixed results regarding TOLAC safety, but this study aims to address limitations in existing literature, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant women age of 18 years or older * Women admitted to the labour ward at gestational age ≥ 34 weeks * Women with a singleton pregnancy * Women with one previous caesarean delivery * Computer savvy-women Exclusion Criteria: Exclusion criteria : * Women who oppose to participation in the study * Age \< 18 years * Women admitted to the labour ward at gestational age \< 34 weeks * Women with multiple pregnancy * Women with more than one previous caesarean or more than one uterine scar * Women who do not understand the French language * Women under judicial protection
Where this trial is running
Marseille, Bouches-du-rhône
- Assistance Publique Hôpitaux Marseille — Marseille, Bouches-du-rhône, France (Recruiting)
Study contacts
- Principal investigator: Julie BLANC — Assitance Publique Hopitaux Marseille
- Study coordinator: Julie BLANC
- Email: julie.blanc@ap-hm.fr
- Phone: 0491964672
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.