Pennell 2009.
Methods | RCT: generation of sequence unclear, sealed opaque envelopes, patient chose from a selection of 12. | |
Participants | Inclusion: primipara, GA > 36 weeks, intact membranes, BS < 4.singleton fetus, cephalic presentation, intact membranes. Exclusion criteria were age < 16 years, previous uterine surgery, low‐lying placenta, any active or purulent infection of the lower vaginal tract, or an abnormal pre‐induction FHR tracing |
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Interventions | Foley catheter 30cc. (110). Atad catheter 80 cc. (107). PGE 2 gel 2 mg, 6‐hourly. (113). |
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Outcomes | Vaginal delivery within 24 hours, uterine hyperstimulation with/without FHR changes, CS, epidural analgesia, instrumental vaginal delivery, antibiotics during labour, postpartum haemorrhage, maternal fever during labour, pH < 7.10, placental abruption, endometritis, wound infection. | |
Notes | Data for Foley catheter and double balloon catheter were entered in 1 comparison (any mechanical method versus PG). Setting: King Edward Memorial Hospital (KEMH) in Perth, Western Australia Dates of study: July 2001 to December 2003 Funding sources: supported by a grant from the Women and Infants Research Foundation, King Edward Memorial Hospital, Perth, Australia. Adeza Biomedical Corporation contributed support for the fetal fibronectin test kits. Declarations of interest: none declared |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information about sequence generation process in the paper. |
Allocation concealment (selection bias) | Low risk | Sealed opaque envelopes (but why selection of 12??). |
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 | Low risk | Research midwives were blinded to treatment allocation, especially important for satisfaction questionnaires. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | ITT, loss to follow‐up is described, incomplete data not mentioned. |
Selective reporting (reporting bias) | Low risk | All outcomes prespecified in methods were reported, report includes all expected outcomes. |
Other bias | Low risk | No other bias detected. |