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. 2019 Oct 18;2019(10):CD001233. doi: 10.1002/14651858.CD001233.pub3

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
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
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