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 |