Atad 1996.
Study characteristics | ||
Methods | RCT. Computer‐generated sequence. No details were given on the method for concealment of the allocation. | |
Participants | Singleton vertex term pregnancies with intact membranes, BS < 5 without previous CS. | |
Interventions | Atad ripening device (35 women); PGE2 intravaginal tablets 3 mg (30 women); oxytocin (30 women). | |
Outcomes | Need for another method, CS, change in BS. | |
Notes | Also reported as abstract (Abramovici 1994). Setting: Israel Study period: not reported Funding: not reported Declarations of interest: J Atad has a patent licensing arrangement for Atad ripening device and thus has the potential gain from its sales |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer random‐generated allocation list |
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 | Low risk | No ITT reported, but seems reasonable as numbers in tables are equal to randomised numbers, no missing data or cases |
Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes reported |
Other bias | Low risk | No other bias detected |