Interventions for treating genital <i>Chlamydia trachomatis</i> infection in pregnancy

Catherine Cluver; Natalia Novikova; David OA Eriksson; Kevin Bengtsson; Göran K Lingman

doi:10.1002/14651858.CD010485.pub2

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Figure 1

Study flow diagram.

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Figure 2

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

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Figure 3

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

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Analysis 1.1

Comparison 1 Erythromycin versus placebo, Outcome 1 Microbiological cure.

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Analysis 1.2

Comparison 1 Erythromycin versus placebo, Outcome 2 Preterm birth.

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Analysis 1.3

Comparison 1 Erythromycin versus placebo, Outcome 3 Preterm rupture of membranes.

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Analysis 1.4

Comparison 1 Erythromycin versus placebo, Outcome 4 Side effects of treatment.

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Analysis 1.5

Comparison 1 Erythromycin versus placebo, Outcome 5 Perinatal mortality.

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Analysis 1.6

Comparison 1 Erythromycin versus placebo, Outcome 6 Low birthweight.

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Analysis 2.1

Comparison 2 Clindamycin versus placebo, Outcome 1 Microbiological cure.

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Analysis 2.2

Comparison 2 Clindamycin versus placebo, Outcome 2 Side effects of treatment.

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Analysis 3.1

Comparison 3 Amoxicillin versus placebo, Outcome 1 Microbiological cure.

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Analysis 4.1

Comparison 4 Amoxicillin versus azithromycin, Outcome 1 Microbiological cure.

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Analysis 4.2

Comparison 4 Amoxicillin versus azithromycin, Outcome 2 Repeated infection.

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Analysis 4.3

Comparison 4 Amoxicillin versus azithromycin, Outcome 3 Preterm birth.

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Analysis 4.4

Comparison 4 Amoxicillin versus azithromycin, Outcome 4 Side effects of treatment.

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Analysis 5.1

Comparison 5 Amoxicillin versus erythromycin, Outcome 1 Microbiological cure.

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Analysis 5.2

Comparison 5 Amoxicillin versus erythromycin, Outcome 2 Side effects of treatment.

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Analysis 6.1

Comparison 6 Azithromycin versus erythromycin, Outcome 1 Microbiological cure.

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Analysis 6.2

Comparison 6 Azithromycin versus erythromycin, Outcome 2 Repeated infection.

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Analysis 6.3

Comparison 6 Azithromycin versus erythromycin, Outcome 3 Preterm birth.

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Analysis 6.4

Comparison 6 Azithromycin versus erythromycin, Outcome 4 Preterm rupture of membranes.

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Analysis 6.5

Comparison 6 Azithromycin versus erythromycin, Outcome 5 Side effects of treatment.

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Analysis 7.1

Comparison 7 Clindamycin versus erythromycin, Outcome 1 Microbiological cure.

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Analysis 7.2

Comparison 7 Clindamycin versus erythromycin, Outcome 2 Side effects of treatment.

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Analysis 8.1

Comparison 8 Amoxicillin versus clindamycin, Outcome 1 Microbiological cure.

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Analysis 8.2

Comparison 8 Amoxicillin versus clindamycin, Outcome 2 Side effects of treatment.

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Summary of findings for the main comparison. Erythromycin compared to placebo for treating genital Chlamydia trachomatis infection in pregnancy

*Erythromycin compared to placebo for treating genital Chlamydia trachomatis* infection in pregnancy**
Patient or population: Pregnant women with a confirmed Chlamydia trachomatis infection Setting: Obstetric Clinics, USA Intervention: Erythromycin Comparison: Placebo
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with placebo	Risk with Erythromycin
Microbiological cure	Study population		Average RR 2.64 (1.60 to 4.38)	495 (2 RCTs)	⊕⊕⊕⊝ MODERATE ^{1 2}
	344 per 1000	908 per 1000 (550 to 1000)
*The risk in the intervention group (and its 95% CI) 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: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ Statistical Heterogeneity (I² > 60%). (Inconsistency: ‐1) ² One included study has design limitations but contributed < 40% weight. (Not downgraded)

Summary of findings for the main comparison. Erythromycin compared to placebo for treating genital Chlamydia trachomatis infection in pregnancy

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Summary of findings 2. Clindamycin compared to placebo for treating genital Chlamydia trachomatis infection in pregnancy

*Clindamycin compared to placebo for treating genital Chlamydia trachomatis* infection in pregnancy**
Patient or population: Pregnant women with a confirmed Chlamydia trachomatis infection Setting: Obstetric Clinic, USA Intervention: Clindamycin Comparison: Placebo
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with placebo	Risk with Clindamycin
Microbiological cure	Study population		RR 4.08 (2.35 to 7.08)	85 (1 RCT)	⊕⊕⊝⊝ LOW ^{1 2}
	227 per 1000	927 per 1000 (534 to 1000)
*The risk in the intervention group (and its 95% CI) 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: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ The included study had design limitation (Design limitations: ‐1) ² Wide confidence interval and small sample size (Imprecision: ‐1)

Summary of findings 2. Clindamycin compared to placebo for treating genital Chlamydia trachomatis infection in pregnancy

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Summary of findings 3. Amoxicillin compared to placebo for treating genital Chlamydia trachomatis infection in pregnancy

*Amoxicillin compared to placebo for treating genital Chlamydia trachomatis* infection in pregnancy**
Patient or population: Pregnant women with a confirmed Chlamydia trachomatis infection Setting: USA Intervention: Amoxicillin Comparison: Placebo
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with placebo	Risk with Amoxicillin
Microbiological cure	Study population		RR 2.00 (0.59 to 6.79)	15 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{1 2}
	333 per 1000	667 per 1000 (197 to 1000)
*The risk in the intervention group (and its 95% CI) 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: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ The included study had design limitation (Design limitations: ‐1) ² Wide confidence intervals crossing the line of no effect, few events, and small sample size (Imprecision: ‐2)

Summary of findings 3. Amoxicillin compared to placebo for treating genital Chlamydia trachomatis infection in pregnancy

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Summary of findings 4. Amoxicillin compared to azithromycin for treating genital Chlamydia trachomatis infection in pregnancy

*Amoxicillin compared to azithromycin for treating genital Chlamydia trachomatis* infection in pregnancy**
Patient or population: Pregnant women with a confirmed Chlamydia trachomatis infection Setting: Prenatal clinics, USA Intervention: Amoxicillin Comparison: Azithromycin
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with azithromycin	Risk with Amoxicillin
Microbiological cure	Study population		RR 0.89 (0.71 to 1.12)	144 (2 RCTs)	⊕⊝⊝⊝ VERY LOW ^{1 2}
	716 per 1000	637 per 1000 (509 to 802)
*The risk in the intervention group (and its 95% CI) 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: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ One study contributing to over 68% of weight to pooled analysis had some design limitations (Design limitations: ‐1) ² Wide confidence intervals crossing the line of no effect and small size (Imprecision: ‐2)

Summary of findings 4. Amoxicillin compared to azithromycin for treating genital Chlamydia trachomatis infection in pregnancy

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Summary of findings 5. Amoxicillin compared to erythromycin for treating genital Chlamydia trachomatis infection in pregnancy

*Amoxicillin compared to erythromycin for treating genital Chlamydia trachomatis* infection in pregnancy**
Patient or population: Pregnant women with a confirmed Chlamydia trachomatis infection Setting: Obstetric centre or prenatal clinics in Canada, USA Intervention: Amoxicillin Comparison: Erythromycin
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with erythromycin	Risk with Amoxicillin
Microbiological cure	Study population		RR 0.97 (0.93 to 1.01)	466 (4 RCTs)	⊕⊕⊕⊕ HIGH	One study contributing to 24% of weight had some design limitation. (not downgraded)
	954 per 1000	925 per 1000 (887 to 963)
*The risk in the intervention group (and its 95% CI) 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: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

Summary of findings 5. Amoxicillin compared to erythromycin for treating genital Chlamydia trachomatis infection in pregnancy

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Summary of findings 6. Azithromycin compared to erythromycin for treating genital Chlamydia trachomatis infection in pregnancy

*Azithromycin compared to erythromycin for treating genital Chlamydia trachomatis* infection in pregnancy**
Patient or population: Pregnant women with a confirmed Chlamydia trachomatis infection Setting: Prenatal clinics, and university medical centres, USA Intervention: Azithromycin Comparison: erythromycin
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with erythromycin	Risk with Azithromycin
Microbiological cure	Study population		Average RR 1.11 (1.00 to 1.23)	374 (6 RCTs)	⊕⊕⊕⊝ MODERATE ^{1 2}
	825 per 1000	916 per 1000 (825 to 1000)
*The risk in the intervention group (and its 95% CI) 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: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ Most studies have design limitations (Design limitations: ‐1) ² Statistical heterogeneity at 53% (I² < 60%) (not downgraded)

Summary of findings 6. Azithromycin compared to erythromycin for treating genital Chlamydia trachomatis infection in pregnancy

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Summary of findings 7. Clindamycin compared to erythromycin for treating genital Chlamydia trachomatis infection in pregnancy

*Clindamycin compared to erythromycin for treating genital Chlamydia trachomatis* infection in pregnancy**
Patient or population: Pregnant women with a confirmed Chlamydia trachomatis infection Setting: Prenatal clinics, USA Intervention: Clindamycin Comparison: Erythromycin
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with erythromycin	Risk with Clindamycin
Microbiological cure	Study population		RR 1.06 (0.97 to 1.15)	173 (2 RCTs)	⊕⊕⊝⊝ LOW ^{1 2}
	905 per 1000	959 per 1000 (878 to 1000)
*The risk in the intervention group (and its 95% CI) 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: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ One study contributing to over 40% of weight to pooled analysis had some design limitations (Design limitations: ‐1) ² Small sample size (Imprecision: ‐1)

Summary of findings 7. Clindamycin compared to erythromycin for treating genital Chlamydia trachomatis infection in pregnancy

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Summary of findings 8. Amoxicillin compared to clindamycin for treating genital Chlamydia trachomatis infection in pregnancy

*Amoxicillin compared to clindamycin for treating genital Chlamydia trachomatis* infection in pregnancy**
Patient or population: Pregnant women with a confirmed Chlamydia trachomatis infection Setting: Prenatal clinic, USA Intervention: Amoxicillin Comparison: Clindamycin
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with clindamycin	Risk with Amoxicillin
Microbiological cure	Study population		RR 0.96 (0.89 to 1.04)	101 (1 RCT)	⊕⊕⊕⊝ MODERATE ¹
	979 per 1000	940 per 1000 (871 to 1000)
*The risk in the intervention group (and its 95% CI) 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: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ The pooled effect was based on one study with a small sample size (Imprecision: ‐1)

Summary of findings 8. Amoxicillin compared to clindamycin for treating genital Chlamydia trachomatis infection in pregnancy

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Comparison 1. Erythromycin versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Microbiological cure Show forest plot	2	495	Risk Ratio (M‐H, Random, 95% CI)	2.64 [1.60, 4.38]

2 Preterm birth Show forest plot	1	405	Risk Ratio (M‐H, Fixed, 95% CI)	0.90 [0.56, 1.46]

3 Preterm rupture of membranes Show forest plot	1	389	Risk Ratio (M‐H, Fixed, 95% CI)	0.83 [0.48, 1.43]

4 Side effects of treatment Show forest plot	2	495	Risk Ratio (M‐H, Random, 95% CI)	2.93 [0.36, 23.76]

5 Perinatal mortality Show forest plot	1	405	Risk Ratio (M‐H, Fixed, 95% CI)	3.01 [0.32, 28.74]

6 Low birthweight Show forest plot	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	0.77 [0.42, 1.40]

Comparison 1. Erythromycin versus placebo

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Comparison 2. Clindamycin versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Microbiological cure Show forest plot	1	85	Risk Ratio (M‐H, Fixed, 95% CI)	4.08 [2.35, 7.08]

2 Side effects of treatment Show forest plot	1	85	Risk Ratio (M‐H, Fixed, 95% CI)	5.37 [0.65, 44.01]

Comparison 2. Clindamycin versus placebo

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Comparison 3. Amoxicillin versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Microbiological cure Show forest plot	1	15	Risk Ratio (M‐H, Fixed, 95% CI)	2.0 [0.59, 6.79]

Comparison 3. Amoxicillin versus placebo

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Comparison 4. Amoxicillin versus azithromycin

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Microbiological cure Show forest plot	2	144	Risk Ratio (M‐H, Fixed, 95% CI)	0.89 [0.71, 1.12]

2 Repeated infection Show forest plot	1	34	Risk Ratio (M‐H, Fixed, 95% CI)	0.42 [0.02, 9.55]

3 Preterm birth Show forest plot	1	90	Risk Ratio (M‐H, Fixed, 95% CI)	1.17 [0.43, 3.20]

4 Side effects of treatment Show forest plot	1	36	Risk Ratio (M‐H, Fixed, 95% CI)	0.56 [0.24, 1.31]

Comparison 4. Amoxicillin versus azithromycin

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Comparison 5. Amoxicillin versus erythromycin

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Microbiological cure Show forest plot	4	466	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.93, 1.01]

2 Side effects of treatment Show forest plot	4	513	Risk Ratio (M‐H, Fixed, 95% CI)	0.31 [0.21, 0.46]

Comparison 5. Amoxicillin versus erythromycin

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Comparison 6. Azithromycin versus erythromycin

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Microbiological cure Show forest plot	6	374	Risk Ratio (M‐H, Random, 95% CI)	1.11 [1.00, 1.23]

2 Repeated infection Show forest plot	1	85	Risk Ratio (M‐H, Fixed, 95% CI)	1.37 [0.32, 5.73]

3 Preterm birth Show forest plot	1	126	Risk Ratio (M‐H, Fixed, 95% CI)	0.77 [0.29, 2.10]

4 Preterm rupture of membranes Show forest plot	1	126	Risk Ratio (M‐H, Fixed, 95% CI)	0.62 [0.15, 2.48]

5 Side effects of treatment Show forest plot	6	374	Risk Ratio (M‐H, Fixed, 95% CI)	0.24 [0.17, 0.34]

Comparison 6. Azithromycin versus erythromycin

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Comparison 7. Clindamycin versus erythromycin

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Microbiological cure Show forest plot	2	173	Risk Ratio (M‐H, Fixed, 95% CI)	1.06 [0.97, 1.15]

2 Side effects of treatment Show forest plot	2	183	Risk Ratio (M‐H, Fixed, 95% CI)	0.44 [0.22, 0.87]

Comparison 7. Clindamycin versus erythromycin

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Comparison 8. Amoxicillin versus clindamycin

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Microbiological cure Show forest plot	1	101	Risk Ratio (M‐H, Fixed, 95% CI)	0.96 [0.89, 1.04]

2 Side effects of treatment Show forest plot	1	107	Risk Ratio (M‐H, Fixed, 95% CI)	0.57 [0.14, 2.26]

Comparison 8. Amoxicillin versus clindamycin

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