Husain 2017.
Methods | RCT | |
Participants | Inclusion: age 20 to 40 years, singleton pregnancy, cephalic presentation ≥ 37 weeks Exclusion: BS of > 4, cephalopelvic disproportion on examination, history of placenta previa or unexplained vaginal bleeding, history of previous CS or other uterine surgery, active herpes simplex infection, chorioamnionitis, contraindication to use of PGs, acute pelvic inflammatory disease, contraindication to vaginal delivery, a non reassuring FHR pattern prior to induction. |
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Interventions | Oral misoprostol (n = 157): 50 mcg, every 4 hours, max 4 gifts Foley catheter + oral misoprostol (n = 161): 16 or 18F, filled with 30 mL + oral misoprostol (50 mcg) every 4 hours, max 4 gifts both groups: if labour was not established within 4 hours of the 4th dose of misoprostol, induction was considered to have failed and such cases were then delivered by CS. |
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Outcomes | Failure to achieve vaginal delivery after 24 hours, induction‐to‐delivery interval, mode of delivery, reason for CS maternal complications, NICU admissions | |
Notes | Setting: Abbasi Shaheed Hospital in Karachi, Pakistan, tertiary care centre Study period: May 2016 to October 2016. Funding: no funding reported Declarations of interest: none declared |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated sequence, block randomisation |
Allocation concealment (selection bias) | Low risk | Sequentially‐numbered opaque, sealed envelopes |
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 | High risk | ITT analysis not reported, cases excluded because of protocol violation. no missing data or cases |
Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes were reported in results |
Other bias | Low risk | No other bias detected |