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 |
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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 |
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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 |
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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 |