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. 2019 Oct 18;2019(10):CD001233. doi: 10.1002/14651858.CD001233.pub3

Lyndrup 1994.

Methods RCT
Participants Singleton vertex pregnancy, intact membranes with unfavourable cervix.
Interventions Foley extra‐amniotic 30 mL (59 women)
 PGE2 2.5 mg pessaries (50 women)
Outcomes Vaginal delivery not achieved within 24 hours, CS, instrumental delivery, women not satisfied, caregiver not satisfied, pH, AS.
Notes Setting: Denmark
Study:period: June 1990 ‐ March 1993
Funding sources: not reported
Declarations of interest: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No details on the method of generation of the sequence.
Allocation concealment (selection bias) Low risk Concealment of allocation by 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 High risk ITT reported, but 4 women were lost to follow‐up. Women were excluded if delivered after 48 hours
Selective reporting (reporting bias) Low risk All pre‐specified outcomes reported
Other bias Low risk No other bias detected