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 |