1. Sample size calculation.
Outcomes | Baseline rate | ? Important change | Rel. Risk | Total sample size |
Failure to achieve vaginal birth within 24 hours | 30% | 21% | 0.7 | 778 |
Caesarean section (CS) | 10% | 7% | 0.7 | 1294 |
Hyperstimulation | 1% | 0.7% | 0.7 | 30,716 |
Perinatal mortality and morbidity | 0.5% | 0.35% | 0.7 | 61,686 |
Uterine rupture in women with previous CS | 0.5% | 0.35% | 0.7 | 61,686 |
Maternal death or serious morbidity | 0.2% | 0.14% | 0.7 | 154,598 |