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 |