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

Barda 2018.

Methods RCT
Participants Inclusion criteria: GA ≥ 37 weeks, parity 1 to 3, singleton pregnancy with a vertex presentation, BS less than 5) and intact membranes.
Exclusion criteria: previous CS, lack of prenatal care, contraindication for vaginal delivery
Interventions Foley catheter (n = 150): 22 F, 80 mL balloon (max 18 hours)
Dinoproston (n = 150): 3 mg tablets (every 8 hours, max 2 gifts)
Outcomes Start induction to active labour (4 cm dilatation and 80% effacement), labour within 24 hours, CS rate, excessive haemorrhage, chorioamnionitis, non‐reassuring FHR, fetal pH, NICU admission, early neonatal sepsis
Notes Setting: Edith Wolfson Medical Centre, Holon, Israel
Study period: June 2015 ‐ July 2016
Funding: not reported
Declarations of interest: none declared
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Random assigned; not described how this was done. In trial registration => parallel assignment.
Allocation concealment (selection bias) Unclear risk Random assigned; not described how this was done. In trial registration => parallel assignment.
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, no tables available, so incomplete data can not be judged, no missing data described
Selective reporting (reporting bias) Low risk All pre‐specified outcomes were reported in results
Other bias Unclear risk Full text is an accepted manuscript without tables, therefore risk of bias cannot properly be determined