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

Biron‐Shental 2004.

Study characteristics
Methods Randomised trial.
Participants Term, singleton pregnancy BS 4 or less, medical indication for labour induction.
Interventions PGE 2 gel 2 mg (27).
Double balloon catheter (26)
combined (24)
Outcomes Change in BS, need for oxytocin augmentation.
Notes Outcomes of interest not reported.
Setting: Israel
Study period: not reported
Funding: not reported
Declarations of interest: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated sequence.
Allocation concealment (selection bias) Unclear risk Not mentioned.
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 described
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Brief communication, for the reported data no missing. Incomplete outcome data not further mentioned in this report.
Selective reporting (reporting bias) Unclear risk Our outcomes of interest are not reported here, main outcome is change in BS.
Other bias Unclear risk Hard to say, very short report, our outcomes of interest not mentioned, not clear how sample size was calculated.