Parazzini 1998.
Methods | Multicenter study, parallel with cross over. Central telephonic randomization into two arms. | |
Participants | Participants: 320.
Multigravid and primigravid patients.
Inclusion criteria: Singleton pregnancies; cephalic presentations; intact membranes; gestation >36 weeks (>40 weeks); Bishop score >4 (5‐7); parity 0‐3; less than six uterine contractions/hour. Exclusion criteria: Previous caesarean section; diabetes; hypertension/PET; ruptured membranes. |
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Interventions | Intervention 1: Intravenous oxytocin followed in 1 hour by amniotomy (dose 1 mU/m min; rate doubled every 30 min to max 32 mU/min.
Intervention 2: Vaginal PGE2 (Prepidil gel, Upjohn 2mg ); two doses at six hourly intervals. Crossover did occur after 12 hours if patients were not in established labour. |
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Outcomes | Included outcomes: Caesarean section. Uterine hyperstimulation; instrumental vaginal delivery; neonatal intensive care admission; nausea; fever. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |