Process for decision-making, obstetrical risk management and mode of delivery after a prior cesarean delivery in Québec

• Register: ISRCTN
• Last refreshed on: 8 January 2024
• Main ID: ISRCTN15346559
• Date of registration: 20/08/2015
• Prospective Registration: Yes
• Primary sponsor: CHU de Québec Research Center
• Public title: Process for decision-making, obstetrical risk management and mode of delivery after a prior cesarean delivery in Québec
• Scientific title: Process for decision-making, obstetrical RISk management and Mode of delivery After a prior cesarean delivery in Québec (PRISMA): a multicentre, two arms, randomized cluster trial
• Date of first enrolment: 01/04/2016
• Target sample size: 24500
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN15346559
• Study type: Interventional
• Study design: Multicentre stratified, cluster randomized, parallel-group trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Canada

Contacts

• Name: Nils Chaillet

Key inclusion & exclusion criteria

Inclusion criteria: Hospital level:
1. Public hospitals with functional surgical rooms and high performance sonographic devices.
2. More than 300 deliveries per year
3. Written agreement to participate in the study from the directors of maternity services and professional services

Woman level (data collection):
1. All women with one prior cesarean delivery who delivered at participating centers and whose newborns had a gestational age of at least 22 weeks and weighed at least 500 g at delivery.
Exclusion criteria: Hospital level:
1. Public hospitals with, at the time of recruitment, recent or ongoing quality-improvement programs specifically designed to target women with one prior cesarean delivery
Woman level (data collection):
2. Women that give birth or abort before 22 weeks of gestation

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Choice of mode of delivery among women with one prior cesarean delivery
Pregnancy and Childbirth

Intervention(s)

1. Intervention group hospitals:
1.1. A tool to assess the woman a priori intentions for a trial of labor or an elective repeat cesarean delivery
1.2. An estimate of the risk of uterine rupture using ultrasound measurement of lower uterine segment thickness
1.3. An estimate of the chance of success of trial of labor using demographic and patient factors with a validated decision aid (Grobman nomogram)
1.4. A professional training program from the Society of Obstetricians and Gynaecologists of Canada to standardize management of women with one prior cesarean delivery and intrapartum management for a trial of labor
2. Control group hospitals:
2.1. Usual care

Primary Outcome(s)

1. Major perinatal morbidity measured at the mid and at the end of the 2-years intervention period.
This composite outcome includes:
1.1. In utero, intrapartum and neonatal death, defined as the fetal death in utero, during labor or as the newborn death at less than 28 days of age (excluding lethal congenital abnormalities)
1.2. APGAR score at 5 mn < 4
1.3. Metabolic acidosis (umbilical arterial pH < 7 + base excess = -12 mmol/l)
1.4. Major trauma (skull fracture, subdural / subarachnoid haemorrhage, brachial plexus injury, spinal-cord injury, major genital injury, paresis/paralysis at discharge)
1.5. Intracerebral / Intraventricular haemorrhage (grade 3 and 4)
1.6. Periventricular leukomalacia
1.7. Seizure (occurring from delivery to discharge)
1.8. Invasive mechanical ventilation with endotracheal intubation
1.9. Major respiratory morbidity (BPD : neonatal bronchopulmonary dysplasia treated with oxygen or ventilation at 36 weeks post-menstrual age or at 28 days of life, PPHN : Persistent Pulmonary Hypertension of the Newborn, Pneumothorax, Pulmonary haemorrhage, Hyaline membrane disease requiring mechanical ventilation)
1.10. Necrotising enterocolitis (NEC) - (stage 2 and 3)
1.11. Hypoxic-ischemic encephalopathy (APGAR 5mn < 4 + pH < 7 + base excess < -12 mmol/L + seizure)
1.12. Proven neonatal sepsis/infection (positive blood or cerebrospinal fluid culture)
1.13. Hypotension requiring vasopressor support
2. Data will be collected every day from women and neonatal clinical records during the 3.5 years of the program in the 40 hospitals (20 control and 20 interventions), to compare major perinatal morbidity in the intervention group with the rate in the control group at the end of the 2-years intervention period (year 3 and 4).
3. In the primary intention-to-treat analyses, we will assess the effect of the intervention on the rate of major perinatal morbidity using the multivariable generalized-estimating-equations extension of logistic regression, with an exchangeable covariance matrix, to account for the clustering of women within hospitals.
4. Changes in the risk of major perinatal morbidity in the two study groups between the 1-year baseline (preintervention) period and the 2-years intervention period will be compared with the use of an adjusted odds ratio (with 95% confidence intervals) for the interaction between group (intervention vs. control) and time period (intervention period vs. baseline).
5. The adjusted odds ratio for interaction will be estimated with the use of data on women who will deliver during the baseline period or the intervention period and will measure the intervention effect with the difference-in-differences approach, which is adapted for generalized-estimating equations analyses of clustered binary outcomes.

Secondary Outcome(s)

Measured at the mid and at the end of the 2-years intervention period
1. Major maternal morbidity rate
2. Minor perinatal morbidity rate
3. Minor maternal morbidity rate
4. Vaginal Birth After Cesarean rate

Secondary ID(s)

CIHR NRF-142448

Source(s) of Monetary Support

Canadian Institutes of Health Research

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; University Laval Regional Ethics Board, 09/12/2015, ref: MP-20-2016-2718

Results

• Results available: Yes
• Date Completed: 30/09/2020