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

Hudon 1999.

Study characteristics
Methods RCT. No details on the method of randomisation or on concealment of the allocation.
Participants Term, unfavourable cervix (BS < 5).
Interventions Foley catheter placed above the internal os and inflated with 40 mL left in place for a max of 16 hours (56 women); intracervical PGE2 (0.5 mg), repeated if BS unfavourable (55 women). Oxytocin was given after achievement of cervical ripening.
Outcomes CS.
Notes Setting: USA
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 Only reported women were randomised
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 Insufficient information to judge
Selective reporting (reporting bias) Unclear risk Insufficient information to judge
Other bias Unclear risk Abstract only