Chua 1997.
Methods | RCT. Random number table, no details on the method of concealment of the allocation. | |
Participants | Singleton vertex presentation, unfavourable cervix (BS < 6). 185 women recruited (90 in Dilapan group, 95 in PGE2 group). | |
Interventions | Dilapan group: 4 dilators. PGE2 Gel (Prepidil): 0.5 mg. In both groups, ripening was followed by rupture of membranes and oxytocin after 12 hours. | |
Outcomes | Need for oxytocin, CS, instrumental delivery, uterine rupture, uterine hyperstimulation, admission to NICU, perinatal death. | |
Notes | Setting: National University hospital, Singapore 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) | Low risk | Random number table |
Allocation concealment (selection bias) | Unclear risk | Not reported |
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 | ITT not mentioned but seems reasonable as numbers in tables are equal to randomised numbers, no reporting of missing cases or outcomes |
Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes reported |
Other bias | Low risk | No other bias detected |