Choice of mode of delivery among women with one prior cesarean delivery Pregnancy and Childbirth
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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