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

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.
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.
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
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