| Methods |
Randomised controlled trial |
| Data |
Setting: secondary care, Denmark. 118 women giving birth at 1 of 3 hospitals and eligible for the Danish Calmette Study |
| Comparisons |
Investigated the effect of different trial information and consent methods |
| Outcomes |
Proportion recruited to trial |
| Notes |
|
| Risk of bias |
| Item |
Authors' judgement |
Description |
| Random Sequence generation ok? |
Yes |
Central, web‐based block‐randomisation with variable block sizes of 2, 4, and 6 in random order |
| Allocation concealment? |
Yes |
See above |
| Blinding of participants and personnel ok? |
Yes |
Participants blinded although staff giving information were not , though they followed an SOP regarding what to say. Probably didn't affect outcome |
| Blinding of outcome assessment ok? |
Yes |
Outcome objective |
| Incomplete outcome data handled ok? |
Yes |
Adequate |
| Free of selective reporting? |
Yes |
Recruitment outcome presented, which is all the review needs |
| Was the study free of other bias? |
Yes |
No other biases apparent |
| Overall bias? |
No |
Low risk of bias |
