Aduloju 2016.
Methods | RCT | |
Participants | Inclusion: life singleton pregnancy, cephalic presentation, intact membranes, > 37 weeks, indication for IOL, reactive non stress test. unfavourable cervix (BS < 6) Exclusion: IFD, no prenatal care in study centre, contraindication for vaginal delivery |
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Interventions | A: Foley catheter: 16F, 30 mL (n = 70), max 12 hours, if necessary another Foley for 12 hours (n = 70) B: Foley catheter (16F, 30 cc) + vaginal misoprostol 25 ug every 6 hours(n = 70), max dose 100 ug (4 gifts) (n = 70) C: Vaginal misoprostol alone 25 ug every 6 hours (n = 70) max dose 100 ug (4 gifts) (n = 70) Max induction time all groups: 24 hours |
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Outcomes | Vaginal delivery rate, time interval to achieve favourable cervix, induction delivery interval, oxytocin use, AS at 1 and 5 minutes, asphyxia, NICU admission, uterine tachysystole, uterine hypertonus, hyperstimulation, uterine rupture, FHR abnormalities | |
Notes | Setting: Ekiti State University Teaching tertiary healthcare institution; referral centre for primary and secondary healthcare facilities, 2400 deliveries annually, Nigeria Study period: 1 September, 2014 and 31 August, 2015. Funding: no grant or fund was received Declaration of interest: no conflict of interest |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Blocked randomisation using random table computer‐generated numbers |
Allocation concealment (selection bias) | Low risk | Sealed opaque 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 mentioned |
Incomplete outcome data (attrition bias) All outcomes | Low risk | ITT not mentioned, but is probably the case looking at Figure 1. no missing data or cases. |
Selective reporting (reporting bias) | Low risk | All pre‐specified outcome measures were reported, |
Other bias | Low risk | No other bias detected |