Shorten 2005.
Methods | Randomised trial | |
Participants | Australia Inclusion criteria: pregnant women with 1 previous caesarean section and medically eligible for a trial of vaginal birth Exclusion criteria: more than 1 previous caesarean section; classical or unknown uterine scar; history of uterine rupture or upper segment perforation; multiple pregnancy; and obstetric or medical contraindications to vaginal birth, or trial of vaginal birth or both in the current pregnancy |
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Interventions | Decision‐aid booklet describing risks and benefits of elective repeat caesarean section and trial of labour provided at 28 weeks gestation | |
Outcomes | Mode of delivery, level of knowledge, decisional conflict score, preference for mode of delivery at 36 weeks and postnatal satisfaction | |
Notes | Baseline (control group) CS rate: 30% Date of study: May 2001 to May 2003 Funding: MBF Research Grant, Sydney, The University of Wollongong New Researcher Grant Scheme, Wollongong, and NSW Midwives Association Research Scholarship, Sydney, New South Wales, Australia Conflict of interest: not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Opaque envelopes containing a random allocation for each participant code number were prepared by computer‐based randomized generation" |
Allocation concealment (selection bias) | Low risk | "Opaque envelopes containing a random allocation for each participant code number were prepared by computer‐based randomized generation" |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Insufficient information in the report |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome of interest (mode of delivery) objective |
Baseline characteristics similar? | Low risk | "Socioeconomic and clinical baseline characteristics...were similar, except more intervention women reported experiencing problems after their previous caesarean section (infection, pain, breastfeeding problems) compared with the control group" |
Baseline outcome measurements similar? | Low risk | Baseline outcome measures (pre‐scores) comparable |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Proportion of missing data is similar in both groups |
Selective reporting (reporting bias) | Low risk | No evidence of selective outcome reporting |
Protected against contamination? | Low risk | Decision‐aid was provided only to those in the intervention arm |
Other bias | Low risk | No evidence of other bias |