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. 2023 Mar 30;2023(3):CD001233. doi: 10.1002/14651858.CD001233.pub4

Al‐Ibraheemi 2018.

Study characteristics
Methods RCT
Participants Inclusion: > 37 weeks, singleton fetus, cephalic, BS ≤ 6
Exclusion: rupture of membranes, regular uterine contractions (3 or more contractions per 10 minutes), prior uterine surgery, multiple gestations, malpresentation, contraindication to PGs, non‐reassuring FHR tracing, vaginal bleeding, fetal demise, anomalous fetus, or any contraindication to vaginal delivery
Interventions Foley catheter + misoprostol: (n = 100) 30 mL balloon, filled with 60 mL, gentle traction, max 24 hours and misoprostol vaginal 4‐hourly with a max of 6 doses,
Misoprostol (n = 100) 25 ug vaginally, 4‐hourly with a max of 6 doses
Outcomes Time from placement of the first misoprostol dose to delivery, time to active phase (6 cm or greater), time from active phase to delivery, caesarean delivery rate, uterine tachysystole, estimated blood loss, chorioamnionitis, cord blood pH, 5‐minute AS, NICU admission.
Notes Setting: from the Department of Obstetrics and Gynecology, Mount Sinai West Hospital, New York
Study period: September 2015 to July 2016
Funding: not described
Declaration of interest: none declared
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated sequence
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 Low risk ITT analysis, 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