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

Thiery 1981.

Study characteristics
Methods RCT. Concealment of allocation by envelopes.
Participants Singleton vertex term pregnancies. Favourable cervix (BS > 5).
Interventions Foley catheter with a balloon inflated with 30 mL saline and PGE2 0.5 mg extra‐amniotic (48 women);
PGE2 0.5 mg extra‐amniotic (43 women);
amniotomy and oxytocin if needed (52 women).
Outcomes No outcomes reported.
Notes No relevant outcomes reported.
Setting: Belgium
Study period: not reported
Funding: received free PGE2. not clear if this gift is related to a pharmaceutical company
Declarations of interest: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Prepared envelopes with numbers
Allocation concealment (selection bias) Low risk Concealment of allocation by 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 Low risk Unclear if ITT was performed, but is reasonable as numbers are equal to randomised numbers), no missing cases or data
Selective reporting (reporting bias) Low risk All pre‐specified outcomes reported
Other bias Low risk No other bias detected