Roudsari 2011.
Study characteristics | ||
Methods | RCT | |
Participants | Indication for IOL, GA > 37 weeks, BS < 7, singleton, gestational diabetes mellitus, reassuring FHR tracing, cephalic presentation, intact membranes, low‐located placenta (no definition), and mild pre‐eclampsia. Excluded hypersensitivity to PG, temp > 38, previous CS delivery or other uterine surgery, placenta previa, chorioamnionitis, vaginal bleeding, fetal distress, macrosomia and polyhydramnios. | |
Interventions | Low‐dose vaginal misoprostol: 25 mcg, repeated up to 6 doses every 4 hours. If no BS > 7 after 24 hours, oxytocin was started Foley catheter (n = 59) 18 F, 50 mL. After 12 hours oxytocin was started. |
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Outcomes | interval time from the first intervention to the time of delivery. Uterine tachysystole, uterine hyperstimulation | |
Notes | Setting: Department of Obstetrics, teaching hospitals, Mashhad University of Medical Sciences, Iran Study period: September 2007 to March 2008 Funding: not reported Declarations of interest: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported how |
Allocation concealment (selection bias) | Unclear risk | Not reported how |
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 | Unclear risk | No ITT mentioned, no missing data, 1 woman excluded because of bad participation? |
Selective reporting (reporting bias) | Unclear risk | Time to delivery: not clear from when till delivery, most likely from active phase. primary outcome was for first intervention to delivery. other pre‐specified outcomes reported |
Other bias | Low risk | No other bias detected |