Sawai 1994.
Methods | Randomised by computer‐generated lists. Concealment unclear. | |
Participants | 91 women requiring induction of labour. Inclusion criteria: BS < 9. Exclusion criteria: maternal medical problems, previous uterine surgery, previous stillbirth, abnormal FHR, vaginal bleeding, SROM, regular uterine contractions, abnormal ultrasound findings, fetal weight > 4500 g, non‐reactive NST. |
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Interventions | 2 mg PGE2 vaginal suppositories (n = 38) or identical placebo (n = 42) daily (outpatient administration). Twice‐weekly assessments until 44 weeks. |
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Outcomes | Spontaneous labour, SROM, number of suppositories used, oxytocin use, mode of delivery, Apgar scores, umbilical artery pH, presence of meconium, NICU admission. | |
Notes | University of South Florida College of Medicine, USA. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised by computer‐generated lists. |
Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment not reported. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | No blinding but identical placebo used. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No blinding. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No randomised patients lost to follow‐up. |
Selective reporting (reporting bias) | Unclear risk | Unclear which outcomes prespecified. |
Other bias | Unclear risk | Small, single centre RCT, source of funding for trial not clear. |