Jozwiak 2012.
Methods | RCT | |
Participants | Inclusion criteria: pregnant women scheduled for IOL beyond 37 weeks of gestation with a vital singleton pregnancy in cephalic presentation, intact membranes, and an unfavourable cervix (BS < 6). Exclusion criteria: women younger than 18 years, with a previous CS, placenta praevia, lethal fetal congenital anomaly, or known hypersensitivity for one of the products used for induction were ineligible | |
Interventions | Foley catheter (n = 411): 18F, 30 cc sterile saline. PG E2 gel (408): 1 mg, followed by 1 mg after 6 hours, with a max of 2 doses per 24 hours inserted into the posterior vaginal fornix. An initial dose of 2 mg was allowed in nulliparous women. 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: Feb 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 reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | ITT, 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 |