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. 2023 Mar 30;2023(3):CD001233. doi: 10.1002/14651858.CD001233.pub4

Lewis 1983.

Study characteristics
Methods RCT. No details were given on the method for concealment of the allocation.
Participants Singleton vertex term pregnancy, unfavourable cervix.
Interventions Vaginal pessary 3 mg PGE2 (22 women);
Foley catheter in the extra‐amniotic space 30 mL (22 women);
Control group with no treatment (22 women; exclude)
Outcomes Change in BS, CS, uterine hyperstimulation, AS.
Notes Data on induction‐delivery intervals not interpretable to derive proportion of women with vaginal delivery not achieved in 24 hours.
Setting: Manchester, UK
Study period: not reported
Funding: not reported
Declarations of interest: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Random allocation, no more details reported
Allocation concealment (selection bias) Unclear risk Not reported
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 Unclear risk Unclear if ITT was performed. no missing cases or data reported
Selective reporting (reporting bias) Unclear risk No specific pre specified outcomes reported in method section.
Other bias Low risk No other bias detected