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

NCT05439733 | Unknown

• 1 other identifier: 2022-A00514-39
• Study Type: observational
• Target: 16,800
• Locations: 1 country
• Sites: 1

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.

Conditions

Scarred Uterus

Outcome Measures

Primary Outcomes (1)

• The primary endpoint will be the perinatal morbidity-mortality rate

  Composite measure of: * Perinatal death (any foetal death or death of a liveborn infant before hospital discharge \[excluding lethal congenital anomalies\]) * Birth trauma * SARNAT Stage 2 or 3 hypoxic ischemic encephalopathy * Perinatal asphyxia, which is fulfilment of at least one of the following criteria: * Severe biological signs: Arterial or venous cord blood pH \< 7,0 or Base deficit ≥ 16 mmol/L or Lactate ≥ 11 mmol/L * Or 7.0 \< pH ≤ 7.15, or 10 ≤ base deficit \< 16 mmol/L, ou 8 ≤ lactates \< 11 mmol/l, or not available but with: * Perinatal event (severe non reassuring fetal hearth rate, cord prolapse, uterine rupture, maternal trauma or cardio-respiratory arrest * Or sudden change of fetal hearth rate * Or 10 minutes Apgar score of 5 or less or assisted ventilation initiated at birth and continued for at least 10 minutes * Admission to intensive care with intratracheal intubation or need for ventilation * Length of stay in Neonatal Intensive

  From admission and maximum 28 days after delivery

Secondary Outcomes (8)

• Maternal morbidity-mortality rate

  From admissionand maximum 15 days after delivery

• Uterine rupture rate

  During the surgery and confirmed by an adjudication committee.

• Breastfeeding rate at the time of hospital discharge

  Between day 3 and day 5

• Felt pain during delivery

  6-weeks postpartum

• Breastfeeding rate

  6-weeks postpartum

Study Arms (2)

Exposed group

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

Other: Questionnaire completion

Non-exposed group

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

Other: Questionnaire completion

Interventions

Questionnaire completion OTHER

Women will be asked to complete questionnaires 6 weeks after delivery

Exposed group; Non-exposed group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women age of 18 years or older
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women age of 18 years or older

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hôpitaux Marseille

Marseille, Bouches-du-rhône, 13354, France

RECRUITING

Study Officials

• François CREMIEUX

  ASSITANCE PUBLIQUE HOPITAUX MARSEILLE

  STUDY DIRECTOR

• Julie BLANC

  ASSITANCE PUBLIQUE HOPITAUX MARSEILLE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie BLANC

CONTACT

0491964672; julie.blanc@ap-hm.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: June 30, 2022
• Study Start: August 2, 2022
• Primary Completion: January 1, 2025
• Study Completion: July 1, 2025
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

FR (1)