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. 2017 Sep 13;2017(9):CD007701. doi: 10.1002/14651858.CD007701.pub3

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.
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.
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.