Methods | RCT. | |
Participants | 300 women randomised (1 woman withdrew). Inclusion criteria: singleton, term pregnancy, cephalic presentation, intact membranes, Bishop’s score 6 or less, parity 5 or less, unscarred uterus, normal nonstress test, reliable transportation from home Exclusion criteria: congenital anomaly, dead fetus, IUGR, hypertension, abnormal placenta, poly- or oligohydramnios |
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Interventions | Both groups received vaginal controlled release prostaglandin E2 10mg. Both groups were monitored in the antenatal ward for 1 hour Outpatient group: after initial monitoring women were discharged home to return when in labour or were reviewed after 12 hours (nonstress test). If they were not in labour 24 hours later they returned to hospital for induction of labour as an inpatient. Women were in telephone contact with a nurse every 4 hours and were given detailed instructions on when to seek help. They were asked to remain within easy travelling distance of the hospital Inpatient group: women remained on the antenatal ward throughout and managed in a similar way to the outpatient group |
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Outcomes | Satisfaction with care, length of hospital stay, length of labour, mode of delivery, labour interventions, maternal, fetal and neonatal complications | |
Notes | ||
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer-generated sequence. |
Allocation concealment (selection bias) | Low risk | “Sequential sealed opaque envelopes” opened immediately after the insertion of the PGE2 |
Blinding (performance bias and detection bias) Women |
High risk | Not feasible for this intervention. |
Blinding (performance bias and detection bias) Clinical staff |
High risk | |
Blinding (performance bias and detection bias) Outcome assessors |
High risk | |
Incomplete outcome data (attrition bias) All outcomes |
Low risk | Only 1 woman withdrew from the study after randomisation. |
Selective reporting (reporting bias) | Low risk | None apparent. |
Other bias | Low risk | None apparent. No baseline imbalance apparent. |