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 |