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. 2014 Jun 19;2014(6):CD003101. doi: 10.1002/14651858.CD003101.pub3

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.
Interventions 2 mg PGE2 vaginal suppositories (n = 38) or identical placebo (n = 42) daily (outpatient administration).
Twice‐weekly assessments until 44 weeks.
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.