Skip to main content
. 2023 Mar 30;2023(3):CD001233. doi: 10.1002/14651858.CD001233.pub4

Ntsaluba 1997.

Study characteristics
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