Methods | RCT, 2-arm trial. | |
Participants | Setting: 40 women, setting not clear. Inclusion criteria: women with gestational age 40-42 weeks, singleton, cephalic presentation, intact membranes, Bishop score < 6, reassuring FHR and < 3 contractions in 10 minutes |
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Interventions | Intervention group: 100 mg oral misoprostol, dose repeated every 24 hrs with max of 3 doses. 2 hrs continual fetal monitoring after each dose Comparison group: placebo, with same regime and monitoring as the intervention group |
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Outcomes | Chorioamnionitis, meconium aspiration, uterine hyperstimulation, mean time to active labour | |
Notes | Study reported in brief abstract. | |
Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Unclear | Described as “randomized”. |
Allocation concealment? | Unclear | Placebo controlled, no information on randomisation procedure |
Blinding? Women |
Yes | Described as double-blind, placebo controlled study. |
Blinding? Clinical staff |
Yes | |
Blinding? Outcome assessor |
Unclear | Not described. |
Incomplete outcome data addressed? All outcomes |
Unclear | All women appeared to have been followed up, but little information |