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 |
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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) |
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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 |
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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 |