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

Elliott 1998.

Methods RCT. 4 arm trial.
Participants Setting: Edinburgh, UK.
80 women recruited with IOL scheduled 72 h after recruitment.
Inclusion criteria: primiparous women aged 18 to 40 years, normal viable fetus, 37 to 41 weeks (confirmed by first trimester ultrasound scan), cephalic presentation, Bishop score < 5.
Exclusion criteria: women who showed signs of labour onset, placental insufficiency or contraindication to mifepristone,
Interventions Intervention: group 1: (25 women) oral mifepristone 50 mg. Group 2: (25 women) oral mifepristone 200 mg. (In this review we combined both groups in the analysis although it was not clear how randomisation was achieved in the higher dose study.)
Comparison groups: placebo (2 groups of women 25 compared with the lower dose and 5 with the higher dose. We have combined placebo groups in the analysis in this review as data were reported together in the results in the study reports; group size was very unbalanced for the second part of the study).
Outcomes Additional induction agents required, labour within 72 h, CS, oxytocin augmentation. NICU admission.
Notes It was not clear why the placebo group for the higher dose comparison was so small (5 women) or how randomisation was performed to achieve the unbalanced intervention and control groups.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "Pre‐determined randomisation code."
Allocation concealment (selection bias) Unclear risk "Treatment in predetermined numeric order." It was not clear why the group allocation in the placebo arms of the trial were very unbalanced.
Blinding (performance bias and detection bias) 
 Women Low risk "Neither the patient nor the physician had knowledge of whether a simple oral dose of mifepristone or placebo was given."
Blinding (performance bias and detection bias) 
 Clinical staff Low risk "Neither the patient nor the physician had knowledge of whether a simple oral dose of mifepristone or placebo was given."
Blinding (performance bias and detection bias) 
 Outcome assessor Unclear risk Blinding of outcome assessors not described.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk All women randomised seemed to be accounted for in the analysis, although there was serious imbalance in group size.
Selective reporting (reporting bias) Low risk Stated outcomes are reported.
Other bias Unclear risk In the second part of the study (higher dose) the treatment to placebo ratio was 1:5. It was not clear how randomisation was performed, or why the control group was so small.