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

Jozwiak 2013.

Study characteristics
Methods RCT
Participants Women > 18 years with term pregnancy and unfavourable cervix, requiring IOL. Exclusion criteria were previous CS, non‐vertex presentation of the fetus, ruptured membranes, hypersensitivity for one of the products used for induction, or a lethal congenital anomaly of the fetus
Interventions Foley catheter (107),18F 30 cc sterile saline.
10 mg slow release PG vaginal insert (n = 119). Removed after 12 hours, if BS < 6, after 24 hours new PG vaginal insert was used
2 days of induction, 1 day of " rest" followed by 2 more days of induction in case of BS < 6
Outcomes CS, maternal and neonatal morbidity and time from start induction to birth.
Notes Setting: multicentre, the Netherlands
Study period: February 2009 ‐ May 2010
Funding: none
Declarations of interest: none declared
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated randomisation
Allocation concealment (selection bias) Low risk Web‐based
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 stated
Incomplete outcome data (attrition bias)
All outcomes Low risk ITT analysis, missing outcome data (pH and BMI) balanced in numbers across intervention groups, with similar reasons for missing data across groups. no missing cases
Selective reporting (reporting bias) Low risk All pre‐specified outcomes were reported in results
Other bias Low risk No other bias detected