Tabowei 2003.
Methods | Random number table, opaque sealed envelopes. | |
Participants | Term pregnancy, singleton fetus in cephalic presentation, BS < 4. Exclusion: ruptured membranes, placenta praevia, non‐reactive non‐stress test, EFW > 4000 g, prior uterine incision, parity > 4, contraindication to PGs. |
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Interventions | Foley 50 mL max 12 hours (n = 61). Vaginal misoprostol 25 mcg every 4 hours, max 6 doses (n = 60). |
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Outcomes | Failure to achieve ripening within 12 hours, vaginal delivery within 24 hours, need for oxytocin augmentation, CS rate, tachysystole, hypertonus, meconium, maternal and neonatal complications, AS < 7, NICU admissions, febrile morbidity. | |
Notes | Prior uterine incision is exclusion criterion, but 18 women with previous CS included. Setting: Zonal general hospital, Nigeria Study period: June 1998 to May 2001 Funding: not reported Declarations of interest: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random number table. |
Allocation concealment (selection bias) | Low risk | Opaque sealed 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 reported |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Incomplete outcome data were not mentioned in the report. |
Selective reporting (reporting bias) | Low risk | All outcomes prespecified in methods were reported, report includes all expected outcomes. |
Other bias | Unclear risk | Prior uterine incision is exclusion criterion, but 18 women with previous CS included, they were evenly divided between the groups. |