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 |
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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 |
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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 |