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. Author manuscript; available in PMC: 2014 Aug 11.
Published in final edited form as: Cochrane Database Syst Rev. 2009 Apr 15;(2):CD007372. doi: 10.1002/14651858.CD007372.pub2
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
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
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.