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

Benzineb 1996.

Study characteristics
Methods RCT. Blocks of 10 women. No other details were given on the method for randomisation and on concealment of the allocation.
Participants Singleton vertex term pregnancies with intact membranes, BS < 6.
Interventions Foley catheter inflated with 40 mL of water (50 women); PGE2 intracervical gel 0.5 mg every 24 hours. (n = 50?)
Outcomes Vaginal delivery not achieved within 24 hours, CS, perinatal deaths, cervix unchanged after 24 hours, postpartum haemorrhage.
Notes Setting: Charles Nicolle Hospital, Tunis
Dates of study: not reported
Funding: not reported
Declarations of interest: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Only reported women were random allocated in blocks of 10
Allocation concealment (selection bias) Unclear risk Unclear. 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 not mentioned, no missing data or cases reported
Selective reporting (reporting bias) Unclear risk Outcomes not pre‐specified
Other bias Low risk No other bias detected