Benzineb 1996.
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 |
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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 |