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

Prager 2008.

Methods RCT, not blinded.
Participants Term pregnancy, BS 6 or less, different indication for IOL, including PROM
Exclusion criteria: previous CS, malpresentation, immediate delivery indicated, contraindication to vaginal delivery, contraindication to PGs.
Interventions Foley catheter 30 cc (199).
Dinoproston 2 mg 6‐hourly (191).
Misoprostol 25 mcg vaginally 4‐hourly (199).
Outcomes Uterine hyperstimulation, CS, epidural analgesia, instrumental delivery, meconium, AS, NICU admissions, fever during delivery.
Notes Hyperstimulation is not further specified (with of without FHR changes).
Patients who did not meet inclusion criteria were not excluded retrospectively
Setting: Karolinska university Hospital, Sweden
Dates of study: December 2004 to March 2008
Funding sources: not reported
Declarations of interest: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated sequence.
Allocation concealment (selection bias) Low risk Opaque numbered 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 Missing data described: 3 dinoprostone and 1 catheter. these were excluded.
Selective reporting (reporting bias) Low risk All outcomes prespecified in methods were reported, report includes all expected outcomes.
Other bias Unclear risk Patients who did not meet inclusion criteria were not excluded retrospectively (n = 32).