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

Aduloju 2016.

Study characteristics
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
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
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
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