Matonhodze 2003.
| Study characteristics | ||
| 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 |