Ntsaluba 1997.
Methods | RCT | |
Participants | Singleton vertex presentation with intact membranes, BS < 6, no previous CS. | |
Interventions | Intracervical PGE2 (0.5 mg) (59 women) Foley catheter with a 30 mL balloon extra‐amniotic (53 women) | |
Outcomes | Change in BS, CS, uterine hyperstimulation, fever, neonatal sepsis, fetal distress. | |
Notes | Setting: KIng Henry 8th hospital, Durban, South Africa Study period: not reported Funding: not reported Declarations of interest: not reported |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No other details on the randomisation process. |
Allocation concealment (selection bias) | Low risk | Sealed 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 | Low risk | No ITT reported (although it's likely as numbers are equal as randomised numbers), no missing cases or data |
Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes reported. |
Other bias | Low risk | No other bias detected |