Adriaanse 1995a.

Methods	Multi‐centre randomized, double‐blind study that used both a placebo and control group. I. Blinding of randomization ‐ yes. II. Blinding of intervention ‐ yes. III. Complete follow‐up ‐ yes. IV. Blinding of outcome measurement(s) ‐ cannot tell.
Participants	190 women colonized with GBS in labour and their term neonates. Exclusion criteria: known GBS carrier‐ship, use of antibiotics during the 4 weeks before admission, planned cesarean section, antepartum fetal death, suspected congenital abnormalities, and preterm labour. Study period February 1991 through November 1992 in two hospitals in the city of Nijmegen, The Netherlands.
Interventions	190 women in labour, who later were proven to be GBS carriers, were randomized to 1 of 3 groups. 63 women treated with 10 mL of 0.3% chlorhexidine digluconate gel. 70 were treated with 10 mL of placebo gel. The chlorhexidine or the placebo gel was applied around the portio and onto the fornices. If labour still continued, a second application was given after 10 h. 57 women served as controls without any treatment.
Outcomes	6 infants were colonized in the treated group. 11 were colonized in the placebo group. 7 were colonized in the control group. 1 infant with GBS septicaemia in the treatment group, and none in the control group. No incidence of pneumonia in either group. No incidence of mortality in either group. No incidence of adverse effects to mother or infant in either group.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"Women were randomly assigned, when labour had clearly started, to one of three groups according to a predetermined block (10:10:10) allocation scheme."
Allocation concealment (selection bias)	Unclear risk	No information provided.
Blinding of participants and personnel (performance bias) All outcomes	High risk	"Two groups were treated in a double‐blind manner, with either a chlorhexidine or a placebo gel". A third group that received no treatment must have been known to staff.
Blinding of outcome assessment (detection bias) All outcomes	High risk	"Two groups were treated in a double‐blind manner, with either a chlorhexidine or a placebo gel". A third group that received no treatment must have been known to staff.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Outcome data provided for all GBS carrier mothers and their infants.
Selective reporting (reporting bias)	Unclear risk	The protocol for this study was not available to us so we cannot judge if there were any deviations from the protocol in the execution and reporting of the trial.
Other bias	Low risk	Appears free of other bias.