Lyons 2001.
Methods | RCT, 2 arm trial. | |
Participants | Setting: 40 women, setting not clear. Inclusion criteria: women with gestational age 40 to 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 h with maximum of 3 doses. 2 h 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 | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as "randomized". |
Allocation concealment (selection bias) | Unclear risk | Placebo controlled, no information on randomisation procedure. |
Blinding (performance bias and detection bias) Women | Low risk | Described as double‐blind, placebo controlled study. |
Blinding (performance bias and detection bias) Clinical staff | Low risk | Described as double‐blind, placebo controlled study. |
Blinding (performance bias and detection bias) Outcome assessor | Unclear risk | Not described. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | All women appeared to have been followed up, but little information. |
Selective reporting (reporting bias) | Unclear risk | Study reported in brief abstract; unable to assess this bias domain. |
Other bias | Unclear risk | Study reported in brief abstract; unable to assess this bias domain. |