Skip to main content
. 2019 Oct 18;2019(10):CD001233. doi: 10.1002/14651858.CD001233.pub3

St Onge 1995.

Methods RCT. Computer‐generated allocation sequence. Concealment of allocation by sealed envelopes.
Participants Singleton vertex term pregnancies with intact membranes, BS < 5. Exclusion of women with previous CS, low‐lying placenta.
Interventions Intracervical PGE2 (0.5 mg) (30 women).
 Intracervical Foley catheter inflated with 30 mL (36 women).
Outcomes CS, instrumental delivery, maternal side effects, maternal pyrexia, fetal distress.
Notes 2 women excluded in each group. Also reported as abstract (Lange 1994).
Setting: Foothills Hospital in Calgary, Alberta, Canada
Study period: October 1991 to November 1993
Funding: not reported
Declarations of interest: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated allocation sequence.
Allocation concealment (selection bias) Low risk Concealment of allocation by sealed 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 Unclear risk 2 women in each group excluded (not meeting inclusion criteria or in labour directly after randomisation). no missing cases or data
Selective reporting (reporting bias) Low risk All pre‐specified outcomes reported
Other bias Low risk No other bias detected