Skip to main content
. 2019 Oct 18;2019(10):CD001233. doi: 10.1002/14651858.CD001233.pub3

Matonhodze 2003.

Methods RCT: Computer‐generated random sequence, sealed opaque envelopes.
Participants Inclusion: completed 34 weeks GA, intact membranes
Exclusion: uterine scar, uncontrolled medical complication, non‐vertex presentation, multiple pregnancy, fetal distress, APH.
Interventions Foley catheter + misoprostol (n = 174): 50 mL, traction, max 24 hours, followed by oral misoprostol solution 20 mcg every 2 hours, 40 mcg 2‐hourly after 3 doses, until active labour had started. If after established labour contractions became inadequate: augmentation with misoprostol solution 5‐20 mcg hourly. If ineffective: oxytocin.
Titrated oral misoprostol (n = 176): as described above
Dinoprostone vaginal (n = 176). 2 mg in posterior fornix, repeated after 6 hours. If no active labour after 12 hours: oxytocin
Outcomes Failed vaginal delivery within 24 hours, augmentation, tachysystole, hypersystole, hyperstimulation syndrome, tocolysis, analgesia, meconium, CS, instrumental delivery, maternal side effects, AS < 7, NICU admission, perinatal death, neonatal sepsis.
Notes It is not clear if all patients had an unfavourable cervix (not mentioned in baseline characteristics. Data reported for different numbers of subjects depending on outcome (selective reporting or missing outcome data?).
Setting: Pakistan
Study period: October 2000 ‐ December 2001
Funding: not reported
Declaration of interest: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated random sequence,
Allocation concealment (selection bias) Low risk Sequentially‐numbered opaque, sealed envelopes out of a dispenser. intact membranes/unfavourable cervix, intact membranes/favourable cervix
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 ITT analysis, data reported for different numbers of subjects depending on outcome. not clear why
Selective reporting (reporting bias) Low risk All pre‐specified outcomes were reported in results
Other bias Low risk No other bias detected