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

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.
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
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