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 |