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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15346559
Enrollment
24500
Registered
2015-08-20
Start date
2016-04-01
Completion date
Unknown
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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

Sponsors

CHU de Québec Research Center
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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 exch

Secondary

MeasureTime frame
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

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 26, 2026