Roztocil 1998.
Methods | Allocation according to the week of admission. No concealment of allocation. | |
Participants | Singleton vertex term pregnancies, BS < 5. Excluded if labour, fetal hypoxia, previous CS. | |
Interventions | Dilapan S 4 units, removed after 14 hours (82 women); PGE2 intracervical gel 0.5 mg, 1 dose (83 women). In both groups, PGE2 vaginal tablets were administered after 14 hours for labour induction. | |
Outcomes | CS, hyperstimulation with FHR changes, instrumental vaginal delivery, AS < 7, GI side effects, haemorrhage. | |
Notes | Inadequate method of random allocation and of concealment of allocation. Setting: obstetrics department Brno, Chech Republic Study period: January 1994 to December 1996 Funding: not reported Declarations of interest: not reported |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Allocation according to the week of admission. |
Allocation concealment (selection bias) | High risk | No concealment of allocation |
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 | ITT not reported, but seems reasonable as numbers are equal to randomised numbers. no missing cases or data |
Selective reporting (reporting bias) | Low risk | Pre‐specified outcomes reported |
Other bias | Low risk | No other bias detected |