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

Dalui 2005.

Study characteristics
Methods Randomised prospective study, randomisation method unclear.
Participants Singleton live fetus in cephalic presentation, 33‐42 weeks GA, intact membranes, BS < 4
Exclusion: APH, scarred uterus, low‐located placenta, cervicovaginal infection, history of cardiac disease, glaucoma, convulsive disorder, asthma, jaundice.
Interventions Foley catheter 30 mL 12 hours, followed by oxytocin (n = 50).
PGE2 gel 0.5 mg endocervically oxytocin augmentation after 12 hours (n = 50).
Outcomes Bischop score after 12 hours, percentage of subjects entering spontaneous labour, insertion‐expulsion interval Foley, induction‐delivery interval, amount of oxytocin used, mode of delivery, side effects.
Notes No power calculation, BS lower than most studies, no notes on method of randomisation
Setting: Nehru Hospital, PGIMER, Chandigarh, India
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 'Randomised' method not described.
Allocation concealment (selection bias) Unclear risk 'Randomised' method not described.
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 described
Incomplete outcome data (attrition bias)
All outcomes Low risk Although ITT not mentioned, it seems ITT was used. no missing cases or data
Selective reporting (reporting bias) Low risk All pre=specified data are reported, except for expulsion interval of Foley catheter (this is not an outcome of interest for this review).
Other bias Low risk No other bias detected