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

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