| Methods |
Design: three group parallel trial
Purpose: examine the effect of vaginal chlorhexidine disinfection on the transmission of group B streptococci from mother to child during labour |
| Participants |
Patients: women during labour
Baseline comparability: yes |
| Interventions |
Placebo: vaginal gel without chlorhexidine
Untreated: no vaginal gel
Experimental: vaginal gel with chlorhexidine
(Co‐intervention: NS) |
| Outcomes |
Bacterial transmission rate
Infections |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
'Predefined block (10:10:10) allocation scheme' |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Low risk |
'Two groups were treated in a double‐blind manner with either a chlorhexidine or a placebo gel' |
| Blinding?
Outcome assessor |
Unclear risk |
NS |
| Incomplete outcome data addressed?
All outcomes |
High risk |
Drop‐out >15% or NS |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
Unclear risk |
Not relevant (binary outcome) |
| Trial size > 49? |
Low risk |
N = 654 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Drop‐out >15% or NS |
