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

Shechter‐Maor 2015.

Methods RCT
Participants Inclusion criteria: singleton, GA 37 weeks or more, cephalic presentation, intact membranes, unfavourable cervix (BS =/< 6), oligohydramnios (AFI =/< 5)
Exclusion criteria: multifetal gestation, fetal malpresentation, spontaneous labour, contraindication to PGs or a vaginal delivery (e.g. placenta previa), non‐reassuring FHR tracing, a fetus with major anomalies or previous CS
Interventions 1. Propess (10 mg slow release PGE), n = 26
2. Double balloon (Cook), n = 26
Outcomes Time from induction to active labour (defined as cervical dilation of at least 5 cm), induction to delivery time, CS and operative delivery rates, oxytocin augmentation, uterine tachysystole (defined as greater than 5 uterine contractions in 5 minutes), meconium passage, FHR changes, AS and maternal satisfaction
Notes Setting: Israël
Study period: not reported
Funding: none received
Declarations of interest: none declared
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Using computer‐generated, random sequences
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 reported, no missing data described. No figure 1, all women analysed
Selective reporting (reporting bias) High risk All pre‐specified outcomes reported but secondary outcome 'AS'
Other bias Unclear risk Not mentioned in method section how long balloon/dinoprostone was given and what happened after ripening process.