Taylor 1993.
Methods | Prospective randomised trial; sealed, numbered envelopes; no sample size calculation | |
Participants | Setting: UK Women requiring labour induction due to prolonged pregnancy or pre‐eclampsia, 1 previous pregnancy delivered by lower segment CS, singleton in cephalic presentation, GA ≥ 37 weeks, BS < 9, no cephalopelvic disproportion anticipated |
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Interventions | Amniotomy and IV oxytocin (n = 21) versus 2.5 mg vaginal PGE2 pessary, followed by amniotomy 3 h later + oxytocin (if necessary) 6 h later (n = 21) | |
Outcomes | Induction to delivery time, analgesia, mode of delivery, uterine rupture | |
Notes | Only half of the women included had an unfavourable cervix (BS < 6) 1 uterine rupture in PGE 2 group (after oxytocin) reported in abstract Sellers 1988 (see Taylor 1993) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "predetermined code envelope." |
Allocation concealment (selection bias) | Low risk | Sealed envelopes |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not feasible |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding was not described in the report |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Data of all women included were reported, no ITT analysis done |
Selective reporting (reporting bias) | Unclear risk | Published report includes expected outcomes, but no outcome measures were prespecified in the methods section |
Other bias | Low risk | The baseline characteristics were comparable between the groups |