Clinical trial NCT05439733: Planned Mode of Delivery After Caesarean: a Comparative Prospective National Population-based Cohort Study
Official title: Planned Mode of Delivery After Caesarean: a Comparative Prospective National Population-based Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Scarred Uterus
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 16800
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women age of 18 years or older

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.

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
* 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

Primary outcomes:
measure: The primary endpoint will be the perinatal morbidity-mortality rate
timeFrame: From admission and maximum 28 days after delivery
Secondary outcomes:
measure: Maternal morbidity-mortality rate
timeFrame: From admissionand maximum 15 days after delivery
measure: Uterine rupture rate
timeFrame: During the surgery and confirmed by an adjudication committee.
measure: Breastfeeding rate at the time of hospital discharge
timeFrame: Between day 3 and day 5
measure: Felt pain during delivery
timeFrame: 6-weeks postpartum
measure: Breastfeeding rate
timeFrame: 6-weeks postpartum
measure: Evaluate the satisfaction
timeFrame: 6-weeks postpartum
measure: Evaluate the quality of life
timeFrame: 6-weeks postpartum
measure: Risk of postnatal depression, and post-traumatic stress disorder
timeFrame: 6-weeks postpartum
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux Marseille
state: Bouches-du-rhône
Study officials:
affiliation: ASSITANCE PUBLIQUE HOPITAUX MARSEILLE
name: François CREMIEUX
role: STUDY_DIRECTOR
affiliation: ASSITANCE PUBLIQUE HOPITAUX MARSEILLE
name: Julie BLANC
role: PRINCIPAL_INVESTIGATOR
References: