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 |