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

Allouche 1993.

Study characteristics
Methods RCT. No details were given on the method for concealment of the allocation.
Participants BS < 6, vertex, singleton, no previous CS.
Interventions PGE2 (Prepidil 0.5 mg) intracervical (59 women);
Foley 50 mL (60 women);
PGE2 (Prepidil 0.5 mg) and Foley 50 mL extra‐amniotic (63 women).
Outcomes Uterine hyperstimulation, discomfort during the procedure, maternal and neonatal infection.
Notes Setting: not reported
Dates of study:between April and December 1992
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 Only stated women were randomly allocated
Allocation concealment (selection bias) Unclear risk Unclear
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 not mentioned, no missing data or cases reported
Selective reporting (reporting bias) Unclear risk No outcomes pre‐specified
Other bias Low risk No other bias detected