Laddad 2013.
Methods | RCT | |
Participants | Inclusion criteria: primigravida, > 37 weeks of gestation, singleton pregnancy, cephalic presentation, BS < 4, Intact membranes Exclusion criteria: multiple pregnancy, mal‐presentation, absent membranes, APH, medical disease e.g. heart disease, renal disease, previous LSCS |
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Interventions | Foley catheter (n = 200): PGE2 gel intracervical (n = 200), max 2 doses, failed induction declared if patient was not in active labour after 48 hours |
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Outcomes | Not mentioned in method section | |
Notes | PGE2 dose not described Setting: KIMSDU; India, Study period: January 2011 ‐ December 2012 Funding: none 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 | Only stated that women were randomly assigned |
Allocation concealment (selection bias) | Unclear risk | Only stated that women were randomly assigned |
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 | Unclear if analysis was ITT, (no figure 1) all cases analysed, no missing data described |
Selective reporting (reporting bias) | Unclear risk | No pre ‐specified outcome measures reported, so cannot be determined |
Other bias | Low risk | No other bias detected |