Deshmukh 2011.
Study characteristics | ||
Methods | RCT | |
Participants | Inclusion: primigravida > 37 weeks of gestation, singleton pregnancy, cephalic presentation BS ≤ 3, Intact membranes Exclusion: multiple pregnancy, malpresentation, absent membranes, APH, medical disease, e.g. heart disease, renal disease | |
Interventions | Intracervical Foley (n = 200): if BS < 7 after 6 hours, PGE2 was given PGE2 gel vaginal (n = 200), dose repeated after 6 hours Failure of induction was declared if patient failed to go in active phase of labour within 24 hours of induction |
|
Outcomes | Improvement of BS, induction‐delivery interval, mode of delivery and feto‐maternal outcomes | |
Notes | Setting: India Study period:July 2005 to January 2008 Funding: not reported Declarations of interest: not reported |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Only reported women were randomly assigned |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment 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 | Low risk | ITT. no missing cases or data. no women excluded |
Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes reported |
Other bias | Low risk | No other bias detected |