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

NCT ID: NCT05439733

Last Updated: 2023-06-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 16800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-02
• Study Completion Date: 2025-07-31

Brief 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.

Detailed Description

Primary and secondary objectives :

The primary objective is to evaluate the non-inferiority of TOLAC compared to ERCD on the perinatal morbidity-mortality rate. The secondary objectives are to compare between the TOLAC and ECRD groups: the maternal morbidity-mortality rate, care trajectories of women and child one year after delivery, the uterine rupture rate, pain experienced during delivery, the breastfeeding rates at the time of hospital discharge and at 6-weeks postpartum, the satisfaction, the quality of life, and the bonding of women at 6-weeks postpartum, the risk of postnatal depression, and the post-traumatic stress disorder at 6-weeks postpartum, the medical resource costs and perform a cost-effectiveness analysis or a cost-minimization analysis depending on the result on the primary endpoint, the risk perception of women and of the obstetrician about the course of delivery: at the time of the shared decision-making process with the obstetrician of their planned mode of delivery, two days after delivery, and at 6-weeks postpartum (ancillary study CICAMODA Risk), and the risk of urinary incontinence at 12 months postpartum (ancillary study CICAMODA PP).

Methods :

• Design : the investigators plan a national multicentre prospective observational cohort study.
• General procedure : after admission of the women in the labour ward and within the 72 hours after birth, obstetricians will inform women about the study and determine whether or not they object to participate, in accordance with French law. The investigators will collect data about characteristics of the women, the previous caesarean delivery, the planned mode of delivery, the pregnancy, the course of labour, and postpartum data.
• Schedule : the investigators plan a 12-month inclusion period to obtain a complete view of French practices in planned mode of delivery after one previous caesarean delivery thanks to this observational study. The duration of the follow-up period will be 12-months for each included woman.
• Sample size : thanks to data of 2016 National Perinatal Survey, the investigators assume that TOLAC will be planned in 68.9% of French women with one previous caesarean and ERCD in the remaining 31.1%.

From an analysis of the literature, the investigators estimate that the perinatal morbidity-mortality rate is 0.9% in the ERCD group. The noninferiority boundary based on clinical evidence and an expert committee has validated an estimated rate of perinatal morbidity-mortality of 1.4% in the TOLAC group. According to these assumptions and with a power of 80% and a one-sided alpha risk of 2.5%, the number of women to be included is 4343 in the ERCD group and 9669 in the TOLAC group, i.e. a total of 14,012 women. With anticipation that 5% of women will provide incomplete data to define the primary outcome, 14750 women will be needed.

During the inclusion period, the investigators except to include 16800 women, which will provide enough power to investigate the non-inferiority of TOLAC in terms of perinatal morbidity-mortality.

Conditions

Scarred Uterus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Exposed group

Women with a history of cesarean section and with a base-line attempt after planned cesarean section (TVBAC).

Questionnaire completion

Intervention Type: OTHER

Women will be asked to complete questionnaires 6 weeks after delivery

Non-exposed group

Women with a history of cesarean section and scheduled cesarean section after cesarean section (CPAC).

Questionnaire completion

Intervention Type: OTHER

Women will be asked to complete questionnaires 6 weeks after delivery

Interventions

Questionnaire completion

Women will be asked to complete questionnaires 6 weeks after delivery

Intervention Type: OTHER

Eligibility 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

François CREMIEUX

Role: STUDY_DIRECTOR

ASSITANCE PUBLIQUE HOPITAUX MARSEILLE

Julie BLANC

Role: PRINCIPAL_INVESTIGATOR

ASSITANCE PUBLIQUE HOPITAUX MARSEILLE

Locations

Assistance Publique Hôpitaux Marseille

Marseille, Bouches-du-rhône, France

Site Status: RECRUITING

Countries

France

Central Contacts

Julie BLANC

Role: CONTACT

julie.blanc@ap-hm.fr

0491964672

Facility Contacts

Claire MORANDO

Role: primary

claire.morando@ap-hm.fr

Other Identifiers

2022-A00514-39

Identifier Type: -

Identifier Source: org_study_id