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. 2023 Mar 30;2023(3):CD001233. doi: 10.1002/14651858.CD001233.pub4

Orhue 1995.

Study characteristics
Methods RCT
Participants Singleton, vertex, term fetus, adequate pelvis, maternal height > 155 cm, BS < 5. Exclusion if previous uterine scar, placenta praevia or abruptio, age > 35 years.
Interventions (PGE2) 3 mg every 6 hours, max 3 doses (34 women randomised, 30 women analysed)
oxytocin (2 mU/minute, doubled every 30 minutes, max 32 mU/minute) and ARM (30 women)
Foley 30 mL (30 women)
Outcomes CS, instrumental delivery, uterine hyperstimulation, fetal distress, postpartum haemorrhage.
Notes 4 women excluded in PG group were re‐included for CS results only.
Setting: University of Benin Teaching Hospital, Benin City, Nigeria
Study period: April 1990 ‐ October 1991
Funding: not reported
Declarations of interest: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Allocation sequence from a table of random numbers
Allocation concealment (selection bias) Low risk Concealment of allocation by sequentially numbered, sealed, opaque envelopes
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Not feasible due to nature of intervention
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not reported
Incomplete outcome data (attrition bias)
All outcomes High risk ITT not reported, 4 women excluded in PG group were because of unripe cervix after 12 hours
Selective reporting (reporting bias) Low risk All pre‐specified outcomes reported
Other bias Low risk No other bias detected