Johnson 1985.
Methods | RCT. Sequence based on a random number table. No details were given on the method for concealment of the allocation. | |
Participants | Term, primiparas, BS < 6. | |
Interventions | Lamicel (40 women); PGE2 vaginal gel (4 mg) (40 women). | |
Outcomes | Epidural analgesia, CS, instrumental delivery, uterine hyperstimulation, fetal distress. | |
Notes | Setting: UK Dates of study: not reported Funding: not reported Declarations of interest: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random number table |
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 | ITT unclear, no missing cases or data |
Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes reported |
Other bias | Low risk | No other bias detected |