Montgomery 2007.
| Methods | Randomised trial | |
| Participants | UK 742 pregnant women from 4 maternity units with one previous lower segment caesarean section. Recruited by research midwife at antenatal clinic 10 to 20 weeks gestation |
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| Interventions | Two patient decision‐aids: information programme providing information on the outcomes associated with planned vaginal delivery, elective caesarean section and emergency caesarean section; and a decision analysis containing information on descriptions of outcomes for mother and baby of each delivery method and women are asked to consider a value to these outcomes. This provides a recommended 'preferred option' based on maximised expected utility | |
| Outcomes | Primary: decisional conflict scale and actual mode of delivery Secondary: anxiety, knowledge of the decisional conflict scale and satisfaction | |
| Notes | Baseline (control group) CS rate: 24% Date of study: May 2004 to August 2006 Funding: BUPA Foundation; UK Department of Health National Coordinating Centre for Research Capacity Development Conflict of interest: the authors declare that they have no known conflict of interests |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "One member of the of the study team generated the randomisation sequence by computer..." |
| Allocation concealment (selection bias) | Low risk | "...another member of staff with no involvement in the trial performed the allocation" |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information provided in the report |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Main outcome of interest (mode of delivery) objective |
| Baseline characteristics similar? | Unclear risk | Insufficient information in the report |
| Baseline outcome measurements similar? | Low risk | Outcomes measured before intervention and no important differences reported |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Proportion of missing data similar for each group |
| Selective reporting (reporting bias) | Low risk | Data on all prespecified outcomes reported |
| Protected against contamination? | Low risk | Decision aids only provided to those women randomised to that arm |
| Other bias | Low risk | No evidence of other bias |