Skip to main content
. 2019 Oct 18;2019(10):CD001233. doi: 10.1002/14651858.CD001233.pub3

Jozwiak 2014.

Methods Pilot study within RCT
Participants Women > 18 years, ≥ 37 weeks, BS < 6, planned for IOL.
Exclusion:previous CS, non vertex presentation, ruptured membranes, hypersensitivity for one of the products used for induction, lethal congenital anomaly
Interventions Foley catheter (n = 56), 16 or 18F, 30 mL
Vaginal misoprostol (n = 64) 25 mcg tablets every 4 hours, max 3 doses in 24 hours.
In both groups, if the cervix was still unfavourable for amniotomy after 48 hours of treatment, women were generally assigned a day of rest followed by another 48 hours of induction
Outcomes CS, instrumental vaginal delivery, reasons for operative delivery, time from induction to delivery, uterine hyperstimulation, uterine rupture, analgesics, antibiotics, maternal suspected intrapartum infection, maternal postpartum infection, postpartum haemorrhage (> 1000 cc) postpartum blood transfusion, AS of < 7 at 1 minute and 5 minutes, arterial cord blood pH < 7·10, neonatal admissions neonatal ward/NICU
Notes Setting:multicenter, the Netherlands
Study period: February 2009 and May 2010
Funding: no funding reported
Declarations of interest: none declared
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated sequence, block randomisation
Allocation concealment (selection bias) Low risk Sequentially‐numbered opaque, sealed envelopes
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 analysis, missing data reported, but even distributed over groups and likely for the same reasons. no missing cases
Selective reporting (reporting bias) Low risk All pre‐specified outcomes were reported in results, except secondary outcome maternal postpartum infection
Other bias Low risk No other bias detected