Mazhar 2003.
Methods | RCT randomisation: computer‐generated random numbers, concealed. | |
Participants | Inclusion: singleton pregnancy, cephalic presentation, reassuring fetal status, GA 37 completed weeks, BS 6 or lower. Exclusion: placenta praevia, chorioamnionitis, polyhydramnios, parity > 5, SROM, previous CS, contraindication to labour induction. |
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Interventions | (PGE2) vaginal pessary max 2 x 6 hours (dose not mentioned) followed by ARM and oxytocin infusion (n = 100). Foley catheter 45 mL + EASI for 12 hours followed by ARM and oxytocin infusion (n = 100). |
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Outcomes | Primary: time from insertion to delivery, mode of delivery. secondary: change is BS after 6 hours, neonatal AS. |
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Notes | No sample size calculation. 4 patients were excluded (1 left against medical advice, 1 had SROM, 2 failed inductions were induced at later stage). Setting: Pakistan Dates of study: October 2000 to December 2001 Funding sources: 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 | Computer‐generated sequence. |
Allocation concealment (selection bias) | Unclear risk | Randomised numbers concealed in the delivery suite? |
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 | Unclear risk | No mention of incomplete data, however unlikely due to nature of outcome measures. |
Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes reported. |
Other bias | Low risk | No other bias detected |