Scolaris Content Display Scolaris Content Display

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figuras y tablas -
Figure 1

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
Figuras y tablas -
Figure 2

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.

Comparison 1 Chlorhexidine (vaginal wash or gel/cream) versus placebo or no treatment, Outcome 1 Early onset GBS disease (sepsis and/or meningitis within the first seven days of life)).
Figuras y tablas -
Analysis 1.1

Comparison 1 Chlorhexidine (vaginal wash or gel/cream) versus placebo or no treatment, Outcome 1 Early onset GBS disease (sepsis and/or meningitis within the first seven days of life)).

Comparison 1 Chlorhexidine (vaginal wash or gel/cream) versus placebo or no treatment, Outcome 2 GBS pneumonia within the first seven days of life.
Figuras y tablas -
Analysis 1.2

Comparison 1 Chlorhexidine (vaginal wash or gel/cream) versus placebo or no treatment, Outcome 2 GBS pneumonia within the first seven days of life.

Comparison 1 Chlorhexidine (vaginal wash or gel/cream) versus placebo or no treatment, Outcome 3 Neonatal colonization with GBS within the first seven days of life.
Figuras y tablas -
Analysis 1.3

Comparison 1 Chlorhexidine (vaginal wash or gel/cream) versus placebo or no treatment, Outcome 3 Neonatal colonization with GBS within the first seven days of life.

Comparison 1 Chlorhexidine (vaginal wash or gel/cream) versus placebo or no treatment, Outcome 4 Neonatal mortality due to early‐onset GBS infection.
Figuras y tablas -
Analysis 1.4

Comparison 1 Chlorhexidine (vaginal wash or gel/cream) versus placebo or no treatment, Outcome 4 Neonatal mortality due to early‐onset GBS infection.

Comparison 1 Chlorhexidine (vaginal wash or gel/cream) versus placebo or no treatment, Outcome 5 Adverse (mild) effects in the mother.
Figuras y tablas -
Analysis 1.5

Comparison 1 Chlorhexidine (vaginal wash or gel/cream) versus placebo or no treatment, Outcome 5 Adverse (mild) effects in the mother.

Comparison 1 Chlorhexidine (vaginal wash or gel/cream) versus placebo or no treatment, Outcome 6 Adverse (mild) effects in the neonate.
Figuras y tablas -
Analysis 1.6

Comparison 1 Chlorhexidine (vaginal wash or gel/cream) versus placebo or no treatment, Outcome 6 Adverse (mild) effects in the neonate.

Comparison 2 Chlorhexidine vaginal wash versus mechanical washing with placebo or no treatment, Outcome 1 Early onset GBS disease (sepsis and/or meningitis) within the first seven days of life.
Figuras y tablas -
Analysis 2.1

Comparison 2 Chlorhexidine vaginal wash versus mechanical washing with placebo or no treatment, Outcome 1 Early onset GBS disease (sepsis and/or meningitis) within the first seven days of life.

Comparison 2 Chlorhexidine vaginal wash versus mechanical washing with placebo or no treatment, Outcome 2 GBS pneumonia within in the first seven days of life.
Figuras y tablas -
Analysis 2.2

Comparison 2 Chlorhexidine vaginal wash versus mechanical washing with placebo or no treatment, Outcome 2 GBS pneumonia within in the first seven days of life.

Comparison 2 Chlorhexidine vaginal wash versus mechanical washing with placebo or no treatment, Outcome 3 Neonatal colonization with GBS within the first seven days of life.
Figuras y tablas -
Analysis 2.3

Comparison 2 Chlorhexidine vaginal wash versus mechanical washing with placebo or no treatment, Outcome 3 Neonatal colonization with GBS within the first seven days of life.

Comparison 2 Chlorhexidine vaginal wash versus mechanical washing with placebo or no treatment, Outcome 4 Adverse effects (mild) in the mother.
Figuras y tablas -
Analysis 2.4

Comparison 2 Chlorhexidine vaginal wash versus mechanical washing with placebo or no treatment, Outcome 4 Adverse effects (mild) in the mother.

Comparison 2 Chlorhexidine vaginal wash versus mechanical washing with placebo or no treatment, Outcome 5 Adverse effects (mild) in the neonate.
Figuras y tablas -
Analysis 2.5

Comparison 2 Chlorhexidine vaginal wash versus mechanical washing with placebo or no treatment, Outcome 5 Adverse effects (mild) in the neonate.

Comparison 3 Chlorhexidine digluconate gel or cream versus placebo or no treatment, Outcome 1 Early onset GBS disease (sepsis and/or meningitis within the first seven days of life).
Figuras y tablas -
Analysis 3.1

Comparison 3 Chlorhexidine digluconate gel or cream versus placebo or no treatment, Outcome 1 Early onset GBS disease (sepsis and/or meningitis within the first seven days of life).

Comparison 3 Chlorhexidine digluconate gel or cream versus placebo or no treatment, Outcome 2 GBS pneumonia within the first seven days of life.
Figuras y tablas -
Analysis 3.2

Comparison 3 Chlorhexidine digluconate gel or cream versus placebo or no treatment, Outcome 2 GBS pneumonia within the first seven days of life.

Comparison 3 Chlorhexidine digluconate gel or cream versus placebo or no treatment, Outcome 3 Neonatal colonization with GBS within the first seven days of life.
Figuras y tablas -
Analysis 3.3

Comparison 3 Chlorhexidine digluconate gel or cream versus placebo or no treatment, Outcome 3 Neonatal colonization with GBS within the first seven days of life.

Comparison 3 Chlorhexidine digluconate gel or cream versus placebo or no treatment, Outcome 4 Neonatal mortality due to early‐onset GBS infection.
Figuras y tablas -
Analysis 3.4

Comparison 3 Chlorhexidine digluconate gel or cream versus placebo or no treatment, Outcome 4 Neonatal mortality due to early‐onset GBS infection.

Comparison 3 Chlorhexidine digluconate gel or cream versus placebo or no treatment, Outcome 5 Adverse (mild) effects in the mother.
Figuras y tablas -
Analysis 3.5

Comparison 3 Chlorhexidine digluconate gel or cream versus placebo or no treatment, Outcome 5 Adverse (mild) effects in the mother.

Comparison 3 Chlorhexidine digluconate gel or cream versus placebo or no treatment, Outcome 6 Adverse (mild) effects in the neonate.
Figuras y tablas -
Analysis 3.6

Comparison 3 Chlorhexidine digluconate gel or cream versus placebo or no treatment, Outcome 6 Adverse (mild) effects in the neonate.

Summary of findings for the main comparison. Chlorhexidine (vaginal wash or gel/cream) versus placebo or no treatment

Chlorhexidine (vaginal wash or gel/cream) versus placebo or no treatment

Population: women with vaginal or rectal colonization with GBS during labour and their preterm/term infants
Settings: hospitals in The Netherlands, Sweden, Belgium, Norway
Intervention: chlorhexidine (vaginal wash or gel/cream) versus placebo or no treatment

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Control

Chlorhexidine (vaginal wash or gel/cream) versus placebo or no treatment

Early onset GBS disease (sepsis and/or meningitis within the first seven days of life))

Study population

RR 2.32
(0.34 to 15.63)

987
(2 studies)

⊕⊝⊝⊝
very low1,2

2 per 1000

4 per 1000
(1 to 29)

Moderate

1 per 1000

2 per 1000
(0 to 16)

GBS pneumonia within the first seven days of life

Study population

RR 0.35
(0.01 to 8.6)

987
(2 studies)

⊕⊝⊝⊝
very low1,2

2 per 1000

1 per 1000
(0 to 16)

Moderate

1 per 1000

0 per 1000
(0 to 9)

Neonatal colonization with GBS within the first seven days of life

Study population

RR 0.64
(0.4 to 1.01)

328
(3 studies)

⊕⊝⊝⊝
very low1,3

225 per 1000

144 per 1000
(90 to 227)

Moderate

333 per 1000

213 per 1000
(133 to 336)

Neonatal mortality due to early‐onset GBS infection

See comment

See comment

Not estimable

190
(1 study)

See comment

The outcome was reported with no events.

Adverse (mild) effects in the mother

Study population

RR 8.5
(1.6 to 45.28)

1066
(3 studies)

⊕⊝⊝⊝
very low1,3

2 per 1000

15 per 1000
(3 to 78)

Moderate

0 per 1000

0 per 1000
(0 to 0)

Adverse (mild) effects in the neonate

See comment

See comment

Not estimable

1066
(3 studies)

See comment

The outcome was reported with no events.

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio;

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 Most studies contributing data had design limitations.
2 Wide confidence interval crossing the line of no effect and few events.
3 Few events and small sample size.

Figuras y tablas -
Summary of findings for the main comparison. Chlorhexidine (vaginal wash or gel/cream) versus placebo or no treatment
Comparison 1. Chlorhexidine (vaginal wash or gel/cream) versus placebo or no treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Early onset GBS disease (sepsis and/or meningitis within the first seven days of life)) Show forest plot

2

987

Risk Ratio (M‐H, Fixed, 95% CI)

2.32 [0.34, 15.63]

2 GBS pneumonia within the first seven days of life Show forest plot

2

987

Risk Ratio (M‐H, Fixed, 95% CI)

0.35 [0.01, 8.60]

3 Neonatal colonization with GBS within the first seven days of life Show forest plot

3

328

Risk Ratio (M‐H, Random, 95% CI)

0.65 [0.36, 1.18]

4 Neonatal mortality due to early‐onset GBS infection Show forest plot

1

190

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5 Adverse (mild) effects in the mother Show forest plot

3

1066

Risk Ratio (M‐H, Fixed, 95% CI)

8.50 [1.60, 45.28]

6 Adverse (mild) effects in the neonate Show forest plot

3

1066

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 1. Chlorhexidine (vaginal wash or gel/cream) versus placebo or no treatment
Comparison 2. Chlorhexidine vaginal wash versus mechanical washing with placebo or no treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Early onset GBS disease (sepsis and/or meningitis) within the first seven days of life Show forest plot

1

797

Risk Ratio (M‐H, Fixed, 95% CI)

1.05 [0.07, 16.79]

2 GBS pneumonia within in the first seven days of life Show forest plot

1

797

Risk Ratio (M‐H, Fixed, 95% CI)

0.35 [0.01, 8.60]

3 Neonatal colonization with GBS within the first seven days of life Show forest plot

1

79

Risk Ratio (M‐H, Fixed, 95% CI)

0.32 [0.12, 0.90]

4 Adverse effects (mild) in the mother Show forest plot

2

876

Risk Ratio (M‐H, Fixed, 95% CI)

8.50 [1.60, 45.28]

5 Adverse effects (mild) in the neonate Show forest plot

2

876

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 2. Chlorhexidine vaginal wash versus mechanical washing with placebo or no treatment
Comparison 3. Chlorhexidine digluconate gel or cream versus placebo or no treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Early onset GBS disease (sepsis and/or meningitis within the first seven days of life) Show forest plot

1

190

Risk Ratio (M‐H, Fixed, 95% CI)

6.0 [0.25, 145.22]

2 GBS pneumonia within the first seven days of life Show forest plot

1

190

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3 Neonatal colonization with GBS within the first seven days of life Show forest plot

2

249

Risk Ratio (M‐H, Fixed, 95% CI)

0.81 [0.48, 1.35]

4 Neonatal mortality due to early‐onset GBS infection Show forest plot

1

190

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5 Adverse (mild) effects in the mother Show forest plot

1

190

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6 Adverse (mild) effects in the neonate Show forest plot

1

190

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 3. Chlorhexidine digluconate gel or cream versus placebo or no treatment