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. 2019 Oct 18;2019(10):CD001233. doi: 10.1002/14651858.CD001233.pub3

Gunawardena 2012.

Methods RCT
Participants Uncomplicated primipara with singleton pregnancies who underwent IOL at 40 weeks + 5 days
Interventions PGE2 intracervical (72)
Foley (73)
Outcomes Change in mean MBS, uterine hyper‐stimulation, Broncho‐constriction, nausea and vomiting, postpartum haemorrhage and maternal fever, meconium at membrane rupture, AS at 5 minutes and PBU admission
Notes Abstract only
Setting: Ward 5, Teaching Hospital, Kandy, India
Study period: not reported
Funding: not reported
Declaration of interest: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not reported
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 Unclear risk ITT not mentioned, no missing data or cases reported
Selective reporting (reporting bias) Unclear risk Maternal and neonatal adverse outcomes were not given in numbers
Other bias Low risk No other bias detected