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

Mazhar 2003.

Study characteristics
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.
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).
Outcomes Primary: time from insertion to delivery, mode of delivery.
secondary: change is BS after 6 hours, neonatal AS.
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
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