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. |
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Interventions | Foley catheter 30 cc (199). Dinoproston 2 mg 6‐hourly (191). Misoprostol 25 mcg vaginally 4‐hourly (199). |
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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 |
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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). |