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. 2023 Mar 30;2023(3):CD001233. doi: 10.1002/14651858.CD001233.pub4

Roztocil 1998.

Study characteristics
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