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. |
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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). |
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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 |
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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 |