Orhue 1995.
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 |