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Meta-Analysis
. 2013 Jan 31;2013(1):CD000262.
doi: 10.1002/14651858.CD000262.pub4.

Antibiotics for treating bacterial vaginosis in pregnancy

Peter Brocklehurst  1 , Adrienne Gordon, Emer Heatley, Stephen J Milan
Affiliations
Meta-Analysis

Antibiotics for treating bacterial vaginosis in pregnancy

Peter Brocklehurst et al. Cochrane Database Syst Rev. .

Abstract

Background: Bacterial vaginosis is an imbalance of the normal vaginal flora with an overgrowth of anaerobic bacteria and a lack of the normal lactobacillary flora. Women may have symptoms of a characteristic vaginal discharge but are often asymptomatic. Bacterial vaginosis during pregnancy has been associated with poor perinatal outcomes and, in particular, preterm birth (PTB). Identification and treatment may reduce the risk of PTB and its consequences.

Objectives: To assess the effects of antibiotic treatment of bacterial vaginosis in pregnancy.

Search methods: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 May 2012), searched cited references from retrieved articles and reviewed abstracts, letters to the editor and editorials.

Selection criteria: Randomised trials comparing antibiotic treatment with placebo or no treatment, or comparing two or more antibiotic regimens in pregnant women with bacterial vaginosis or intermediate vaginal flora whether symptomatic or asymptomatic and detected through screening.

Data collection and analysis: Two review authors independently assessed trials for inclusion, trial quality and extracted data. We contacted study authors for additional information.

Main results: We included 21 trials of good quality, involving 7847 women diagnosed with bacterial vaginosis or intermediate vaginal flora.Antibiotic therapy was shown to be effective at eradicating bacterial vaginosis during pregnancy (average risk ratio (RR) 0.42; 95% confidence interval (CI) 0.31 to 0.56; 10 trials, 4403 women; random-effects, T² = 0.19, I² = 91%). Antibiotic treatment also reduced the risk of late miscarriage (RR 0.20; 95% CI 0.05 to 0.76; two trials, 1270 women, fixed-effect, I² = 0%).Treatment did not reduce the risk of PTB before 37 weeks (average RR 0.88; 95% CI 0.71 to 1.09; 13 trials, 6491 women; random-effects, T² = 0.06, I² = 48%), or the risk of preterm prelabour rupture of membranes (RR 0.74; 95% CI 0.30 to 1.84; two trials, 493 women). It did increase the risk of side-effects sufficient to stop or change treatment (RR 1.66; 95% CI 1.02 to 2.68; four trials, 2323 women, fixed-effect, I² = 0%).In this updated review, treatment before 20 weeks' gestation did not reduce the risk of PTB less than 37 weeks (average RR 0.85; 95% CI 0.62 to 1.17; five trials, 4088 women; random-effects, T² = 0.06, I² = 49%).In women with a previous PTB, treatment did not affect the risk of subsequent PTB (average RR 0.78; 95% CI 0.42 to 1.48; three trials, 421 women; random-effects, T² = 0.19, I² = 72%).In women with abnormal vaginal flora (intermediate flora or bacterial vaginosis), treatment may reduce the risk of PTB before 37 weeks (RR 0.53; 95% CI 0.34 to 0.84; two trials, 894 women).One small trial of 156 women compared metronidazole and clindamycin, both oral and vaginal, with no significant differences seen for any of the pre-specified primary outcomes. Statistically significant differences were seen for the outcomes of prolongation of gestational age (days) (mean difference (MD) 1.00; 95% CI 0.26 to 1.74) and birthweight (grams) (MD 75.18; 95% CI 25.37 to 124.99) however these represent relatively small differences in the clinical setting.Oral antibiotics versus vaginal antibiotics did not reduce the risk of PTB (RR 1.09; 95% CI 0.78 to 1.52; two trials, 264 women). Oral antibiotics had some advantage over vaginal antibiotics (whether metronidazole or clindamycin) with respect to admission to neonatal unit (RR 0.63; 95% CI 0.42 to 0.92, one trial, 156 women), prolongation of gestational age (days) (MD 9.00; 95% CI 8.20 to 9.80; one trial, 156 women) and birthweight (grams) (MD 342.13; 95% CI 293.04 to 391.22; one trial, 156 women).Different frequency of dosing of antibiotics was assessed in one small trial and showed no significant difference for any outcome assessed.

Authors' conclusions: Antibiotic treatment can eradicate bacterial vaginosis in pregnancy. The overall risk of PTB was not significantly reduced. This review provides little evidence that screening and treating all pregnant women with bacterial vaginosis will prevent PTB and its consequences. When screening criteria were broadened to include women with abnormal flora there was a 47% reduction in preterm birth, however this is limited to two included studies.

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Conflict of interest statement

None known.

Figures

1
1
'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
2
2
'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
3
3
Funnel plot of comparison: 1 Any antibiotic versus placebo/no treatment, outcome: 1.1 Failure of test of cure.
4
4
Funnel plot of comparison: 1 Any antibiotic versus placebo/no treatment, outcome: 1.5 Preterm birth < 37 weeks.
1.1
1.1. Analysis
Comparison 1 Any antibiotic versus placebo/no treatment, Outcome 1 Failure of test of cure.
1.2
1.2. Analysis
Comparison 1 Any antibiotic versus placebo/no treatment, Outcome 2 Postpartum infection.
1.3
1.3. Analysis
Comparison 1 Any antibiotic versus placebo/no treatment, Outcome 3 Perinatal death.
1.4
1.4. Analysis
Comparison 1 Any antibiotic versus placebo/no treatment, Outcome 4 Incidence of preterm prelabour rupture of membranes.
1.5
1.5. Analysis
Comparison 1 Any antibiotic versus placebo/no treatment, Outcome 5 Preterm birth < 37 weeks.
1.6
1.6. Analysis
Comparison 1 Any antibiotic versus placebo/no treatment, Outcome 6 Preterm birth < 34 weeks.
1.7
1.7. Analysis
Comparison 1 Any antibiotic versus placebo/no treatment, Outcome 7 Preterm birth < 32 weeks.
1.8
1.8. Analysis
Comparison 1 Any antibiotic versus placebo/no treatment, Outcome 8 Incidence of low birthweight.
1.9
1.9. Analysis
Comparison 1 Any antibiotic versus placebo/no treatment, Outcome 9 Neonatal sepsis.
1.10
1.10. Analysis
Comparison 1 Any antibiotic versus placebo/no treatment, Outcome 10 Side‐effects sufficient to stop or change treatment.
1.11
1.11. Analysis
Comparison 1 Any antibiotic versus placebo/no treatment, Outcome 11 Side‐effects not sufficient to stop treatment.
1.12
1.12. Analysis
Comparison 1 Any antibiotic versus placebo/no treatment, Outcome 12 Severe neonatal morbidity.
1.13
1.13. Analysis
Comparison 1 Any antibiotic versus placebo/no treatment, Outcome 13 Admission to neonatal unit.
1.14
1.14. Analysis
Comparison 1 Any antibiotic versus placebo/no treatment, Outcome 14 Late miscarriage.
1.15
1.15. Analysis
Comparison 1 Any antibiotic versus placebo/no treatment, Outcome 15 Moderate/severe visual impairment at childhood follow‐up.
2.1
2.1. Analysis
Comparison 2 Antibiotic versus another antibiotic, Outcome 1 Incidence of premature rupture of membranes.
2.2
2.2. Analysis
Comparison 2 Antibiotic versus another antibiotic, Outcome 2 Preterm birth < 37 weeks.
2.3
2.3. Analysis
Comparison 2 Antibiotic versus another antibiotic, Outcome 3 Admission to neonatal unit.
2.4
2.4. Analysis
Comparison 2 Antibiotic versus another antibiotic, Outcome 4 Prolongation of gestational age (days).
2.5
2.5. Analysis
Comparison 2 Antibiotic versus another antibiotic, Outcome 5 Birthweight (grams).
3.1
3.1. Analysis
Comparison 3 Antibiotics: different routes of administration, Outcome 1 Failure of test of cure.
3.2
3.2. Analysis
Comparison 3 Antibiotics: different routes of administration, Outcome 2 Preterm birth < 37 weeks.
3.3
3.3. Analysis
Comparison 3 Antibiotics: different routes of administration, Outcome 3 Incidence of low birthweight.
3.4
3.4. Analysis
Comparison 3 Antibiotics: different routes of administration, Outcome 4 Absence of abnormal clinical signs (no homogenous discharge, no amine odour after the addition of potassium hydroxide, no clue cells on saline microscopy, and PH<4.5).
3.5
3.5. Analysis
Comparison 3 Antibiotics: different routes of administration, Outcome 5 Incidence of premature rupture of membranes.
3.6
3.6. Analysis
Comparison 3 Antibiotics: different routes of administration, Outcome 6 Admission to neonatal unit.
3.7
3.7. Analysis
Comparison 3 Antibiotics: different routes of administration, Outcome 7 Prolongation of gestational age (days).
3.8
3.8. Analysis
Comparison 3 Antibiotics: different routes of administration, Outcome 8 Birthweight (grams).
4.1
4.1. Analysis
Comparison 4 Antibiotic versus another treatment, Outcome 1 Failure of test of cure.
4.2
4.2. Analysis
Comparison 4 Antibiotic versus another treatment, Outcome 2 Side‐effects (not sufficient to stop or change treatment).
4.3
4.3. Analysis
Comparison 4 Antibiotic versus another treatment, Outcome 3 Perinatal death.
4.4
4.4. Analysis
Comparison 4 Antibiotic versus another treatment, Outcome 4 Preterm birth < 37 weeks.
4.5
4.5. Analysis
Comparison 4 Antibiotic versus another treatment, Outcome 5 Preterm birth < 34 weeks.
4.6
4.6. Analysis
Comparison 4 Antibiotic versus another treatment, Outcome 6 Incidence of low birthweight.
5.1
5.1. Analysis
Comparison 5 Antibiotics: different frequency/dose of administration, Outcome 1 Postpartum uterine infection.
5.2
5.2. Analysis
Comparison 5 Antibiotics: different frequency/dose of administration, Outcome 2 Preterm delivery < 37 weeks.
5.3
5.3. Analysis
Comparison 5 Antibiotics: different frequency/dose of administration, Outcome 3 Incidence of low birthweight.
6.1
6.1. Analysis
Comparison 6 Subgroup analysis ‐ Previous preterm birth versus no previous preterm birth, Outcome 1 Failure of test of cure.
6.2
6.2. Analysis
Comparison 6 Subgroup analysis ‐ Previous preterm birth versus no previous preterm birth, Outcome 2 Perinatal death.
6.3
6.3. Analysis
Comparison 6 Subgroup analysis ‐ Previous preterm birth versus no previous preterm birth, Outcome 3 Preterm delivery < 37 weeks.
6.4
6.4. Analysis
Comparison 6 Subgroup analysis ‐ Previous preterm birth versus no previous preterm birth, Outcome 4 Preterm delivery < 34 weeks.
6.5
6.5. Analysis
Comparison 6 Subgroup analysis ‐ Previous preterm birth versus no previous preterm birth, Outcome 5 Incidence of low birthweight.
6.6
6.6. Analysis
Comparison 6 Subgroup analysis ‐ Previous preterm birth versus no previous preterm birth, Outcome 6 Neonatal sepsis.
7.1
7.1. Analysis
Comparison 7 Subgroup analysis ‐ Intermediate flora/bacterial vaginosis  (Nugent score 4‐10) versus no intermediate flora/bacterial vaginosis, Outcome 1 Failure of test of cure.
7.2
7.2. Analysis
Comparison 7 Subgroup analysis ‐ Intermediate flora/bacterial vaginosis  (Nugent score 4‐10) versus no intermediate flora/bacterial vaginosis, Outcome 2 Perinatal death.
7.3
7.3. Analysis
Comparison 7 Subgroup analysis ‐ Intermediate flora/bacterial vaginosis  (Nugent score 4‐10) versus no intermediate flora/bacterial vaginosis, Outcome 3 Preterm birth < 37 weeks.
7.4
7.4. Analysis
Comparison 7 Subgroup analysis ‐ Intermediate flora/bacterial vaginosis  (Nugent score 4‐10) versus no intermediate flora/bacterial vaginosis, Outcome 4 Preterm birth < 32 weeks.
7.5
7.5. Analysis
Comparison 7 Subgroup analysis ‐ Intermediate flora/bacterial vaginosis  (Nugent score 4‐10) versus no intermediate flora/bacterial vaginosis, Outcome 5 Incidence of low birthweight.
7.6
7.6. Analysis
Comparison 7 Subgroup analysis ‐ Intermediate flora/bacterial vaginosis  (Nugent score 4‐10) versus no intermediate flora/bacterial vaginosis, Outcome 6 Neonatal sepsis.
7.7
7.7. Analysis
Comparison 7 Subgroup analysis ‐ Intermediate flora/bacterial vaginosis  (Nugent score 4‐10) versus no intermediate flora/bacterial vaginosis, Outcome 7 Side‐effects sufficient to stop or change treatment.
7.8
7.8. Analysis
Comparison 7 Subgroup analysis ‐ Intermediate flora/bacterial vaginosis  (Nugent score 4‐10) versus no intermediate flora/bacterial vaginosis, Outcome 8 Late miscarriage.
7.9
7.9. Analysis
Comparison 7 Subgroup analysis ‐ Intermediate flora/bacterial vaginosis  (Nugent score 4‐10) versus no intermediate flora/bacterial vaginosis, Outcome 9 Admission to neonatal unit.
8.1
8.1. Analysis
Comparison 8 Subgroup analysis ‐ Treatment at < 20 weeks' gestation versus > 20 weeks' gestation, Outcome 1 Failure of test of cure.
8.2
8.2. Analysis
Comparison 8 Subgroup analysis ‐ Treatment at < 20 weeks' gestation versus > 20 weeks' gestation, Outcome 2 Preterm birth less than 37 weeks.
8.3
8.3. Analysis
Comparison 8 Subgroup analysis ‐ Treatment at < 20 weeks' gestation versus > 20 weeks' gestation, Outcome 3 Incidence of low birthweight.
8.4
8.4. Analysis
Comparison 8 Subgroup analysis ‐ Treatment at < 20 weeks' gestation versus > 20 weeks' gestation, Outcome 4 Side‐effects not sufficient to stop treatment.
8.5
8.5. Analysis
Comparison 8 Subgroup analysis ‐ Treatment at < 20 weeks' gestation versus > 20 weeks' gestation, Outcome 5 Late miscarriage.
See this image and copyright information in PMC

Update of

References

References to studies included in this review

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Larsson 2006 {published data only}
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Mitchell 2009 {published data only}
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Morales 1994 {published data only}
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NICHD MFMU 2000 {published data only}
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NICHD MFMU 2001 {published data only}
    1. Klebanoff M, Carey C, Hauth JC, Hillier SL, Nugent RP, National Institute of Child Health and Human Development Network of Maternal‐Fetal Medicine Units. Failure of metronidazole to prevent preterm delivery among pregnant women with asymptomatic trichomonas vaginalis infection. New England Journal of Medicine 2001;345:487‐93. - PubMed
Odendaal 2002 {published data only}
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Porter 2001 {published data only}
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Shennan 2006 {published data only}
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Ugwumadu 2003 {published data only}
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References to studies excluded from this review

Andrews 2005 {published data only}
    1. Andrews WW, Goldenberg RL, Hauth JC, Cliver SP, Copper R, Conner M. Interconceptional antibiotics to prevent spontaneous preterm birth: a randomized clinical trial. American Journal of Obstetrics and Gynecology 2006;194:617‐23. - PubMed
Goldenberg 2006 {published data only}
    1. Goldenberg RL, Mwatha A, Read J, Adeniyi‐Jones S, Sinkala M, Msmanga G, et al. The HPTN 024 study: the efficacy of antibiotics to prevent chorioamnionitis and preterm birth. American Journal of Obstetrics and Gynecology 2006;194(3):650‐61. - PubMed
Hawkinson 1966 {published data only}
    1. Hawkinson J, Schulman H. Prematurity associated with cervicitis and vaginitis during pregnancy. American Journal of Obstetrics and Gynecology 1966;94:898‐902. - PubMed
Hitti 2002 {published data only}
    1. Hitti J, Kullberg J, Lee Z, Culhane J, Lawler R, Hogan V, et al. Vaginal inflammation and secretory leukocyte protease inhibitor among women with bacterial vaginosis in early pregnancy: response to antibiotic treatment. Infectious Diseases in Obstetrics and Gynecology 2002;10(Suppl 1):S19.
Holst 1990 {published data only}
    1. Holst E, Brandberg A. Treatment of bacterial vaginosis in pregnancy with a lactate gel. Scandinavian Journal of Infectious Diseases 1990;22:625‐6. - PubMed
Klebanoff 2004 {published data only}
    1. Klebanoff M, Hauth J, MacPherson CA, Carey J, Heine R, Wapner R, et al. Time course of the regression of asymptomatic bacterial vaginosis in pregnancy with and without treatment. American Journal of Obstetrics and Gynecology 2004;190:363‐70. - PubMed
Kurtzman 2008 {published data only}
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Leitich 2003 {published data only}
    1. Leitich H, Bodner‐Adler B, Brunbauer M, Kaider A, Egarter C, Husslein P. Bacterial vaginosis as a risk factor for preterm delivery: a meta‐analysis. American Journal of Obstetrics and Gynecology 2003;189(1):139‐47. - PubMed
McGregor 1994 {published data only}
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Mitchell 2009a {published data only}
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Rosnes 2002 {published data only}
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Schoeman 2005 {published data only}
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Ugwumadu 1999 {published data only}
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Ugwumadu 2006 {published data only}
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References to ongoing studies

Subtil 2008 {published data only}
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References to other published versions of this review

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