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![Page 1: Bacterial Vaginosis and Pregnancy : Clinical Overview and Public Health Implications Deborah B. Nelson, Ph.D. Assistant Professor Center for Clinical Epidemiology.](https://reader036.fdocuments.net/reader036/viewer/2022062712/56649cab5503460f9496bbcf/html5/thumbnails/1.jpg)
Bacterial Vaginosis and Pregnancy: Clinical Overview and
Public Health Implications
Deborah B. Nelson, Ph.D.Assistant Professor
Center for Clinical Epidemiology and BiostatisticsUniversity of Pennsylvania School of Medicine
http://www.med.upenn.edu/crrwh/Nelson.html
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Learning Objectives• Review the Prevalence, Identification, and
Treatment of Bacterial Vaginosis (BV) • Describe the Epidemiology and
Consequences of Bacterial Vaginosis in Pregnancy
• Discuss Current Research Findings• Present the BEAR Project: Hypothesis, Specific
Aims and Methodology
Nelson DB, Macones GA. Bacterial Vaginosis in Pregnancy: Current Findings and Future Directions. Epidemiologic Reviews 2002 (24: 102-108).
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Bacterial Vaginosis: Clinical Background
• BV is the most frequent cause of vaginal discharge
• 3 million cases of BV; 800,000 cases among pregnant women annually (Goldman & Hatch 2000).
• Prevalence of BV: 25%-60% among nonpregnant women; 10-35% among pregnant women (Goldman & Hatch 2000).
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Bacterial Vaginosis: Microbiology
• The normal vagina is an acidic environment inhabited primarily by hydrogen-producing lactobacilli
• There is some change in the microbiological flora of the vagina (due to environmental, behavioral, or hormonal factors)
• BV is characterized by a reduced number of lactobacilli and an overgrowth of gram negative, anaerobic bacteria.
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Bacterial Vaginosis: Microbiology
• Anaerobic organisms in BV include: Mycoplasma hominis, Bacteroides spp., Mobiluncus spp., Gardnerella vaginalis.
• Increase in polyamines resulting in the characteristic odor of BV and the increase in epithelial cell exfoliation.
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Bacterial Vaginosis: Clinical Diagnosis
1. Amsel criteria: three of four clincal conditions
• An elevated vaginal pH (> 4.5).• Amine odor with KOH (whiff test).• Presence of clue cells (20% of cells).• Homogeneous vaginal discharge.
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Bacterial Vaginosis: Amsel’s Clinical Diagnosis
• At least 20% clue cells on wet mount.
• However, gardnerella present 16-42% women without BV.
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Bacterial Vaginosis: Amsel’s Clinical Diagnosis
• Assessment of vaginal pH lacks specificity
• Conduct of Whiff test is subjective and lacks sensitivity
• Identification of clue cells subjected to skill and interpretation of the microscopist
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Bacterial Vaginosis: Nugent’s Clinical Diagnosis
Gram stain using Nugent’s criteria:
• High sensitivity and specificity • Permanent record• Commonly used in epidemiologic
studies (NICHD maternal-fetal medicine unit)
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Bacterial Vaginosis: Clinical Diagnosis
Gram stain using Nugents criteria:
Qty Score Qty Score Qty Score
4+ 0 0 0 0 0 3+ 1 1+ 1 1+ or 2+ 1
2+ 2 2+ 2 3+ or 4+ 2
1+ 3 3+ 3
0 4 4+ 4
LactobacillusGardnerella/Bacteroides Mobiluncus
Total score: >= 7 indicates BV, 4-6 intermediate stage of BV
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Bacterial Vaginosis: Treatment
• Oral Treatment–Metronidazole (Flagyl)
–Clindamycin (Cleocin)
• Topical Treatment–Metronidazole 0.75% vaginal cream
(Metrogel)
–Clindamycin 2% vaginal cream
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Bacterial Vaginosis in Pregnancy:
EpidemiologyRace
Socioeconomic status
Sexual activity
Vaginal douching
Drug use
Psychosocial stress
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Bacterial Vaginosis: Clinical Implications
• Pelvic Inflammatory Disease
• Post-hysterectomy vaginal cuff cellulitis
• Plasma cell endometritis
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Bacterial Vaginosis and Pregnancy:
Clinical Implications• Amniotic fluid infection• Postpartum endometritis• Preterm delivery • Preterm labor• Premature rupture of the membranes• Spontaneous abortion (?)
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Bacterial Vaginosis and Pregnancy:
Current Research
–Hillier et al, 1995:
10,000 pregnant women
16% BV; RR = 1.4 (95% CI: 1.1-1.8).
–Gratacos et al, 1998:
635 pregnant women
20% BV; RR = 3.1 (95% CI: 1.8-29.4).
–Kurki et al, 1992:
790 pregnant women
21% BV; RR = 6.9 (95% CI: 2.5-18.8).
Preterm Delivery
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Bacterial Vaginosis: Treatment paradigm in a pregnant
populationPregnant women
Symptomatic Asymptomatic
High risk Low risk
Screen
Treatment (?) No treatment
Screen (?)
(Hauth 1995, Morale 1994, McDonald 1997, Carey 2001)
Treatment No Treatment
Screen
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Bacterial Vaginosis and PTD:
Current Research• Preterm Prediction Study (Goepfert et al,
2001): BV, cervical interleukin-6 concentration, fetal fibronectin level, short cervical length.
• Indicators of PTL (Hitti, Hillier et al, 2001) : Interleukin-6 and -8, neutrophils, BV and other predictors of amniotic fluid infection.
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Bacterial Vaginosis and Spontaneous Abortion: Current Research
• Sub-analyses–RR: 5.5 (95% CI: 2.3 - 13.3); Hay et al, 1994
–RR: 3.2 (95% CI: 1.4 - 6.9); McGregor et al 1995
• High risk populations–RR: 2.67 (95% CI: 1.26 - 5.63); Ralph et al
1999
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Spontaneous Abortion Epidemiology
Maternal age
Previous spontaneous abortionPrenatal cigarette smoking
Prenatal cocaine use
Chromosomal anomalies
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Bacterial vaginosis Evaluation And early Reproduction
BEAR Project:
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BEAR Project: Study Design
• Four year NICHD-funded study.• Prospective cohort enrolling women
seeking prenatal care.• Exposure: Bacterial Vaginosis.• Outcome: Spontaneous Abortion.• 30 month data collection period (N=2200).
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BEAR Project: Specific Aims
• Aim 1: Among women seeking prenatal care at urban obstetric clinics, characterize the prevalence and predictors of BV.
• Aim 2: Evaluate whether BV during pregnancy is an important, independent predictor of SAB.
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BEAR Project:Eligibility Criteria
• OB patient at their first prenatal care visit seen at the Gates clinic or PTP.
• 12.6 weeks gestation or earlier based on last menstrual period.
• Resident of Philadelphia.• Single, intrauterine pregnancy.
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BEAR Project: Study Methods
• Baseline data collection (Nurse Coordinators)
–Enroll women and obtain informed consent.
–Collect vaginal swabs for all eligible women (regardless of symptoms).
–Obtain urine sample.
–Administer 15 minute questionnaire.
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BEAR Project:Baseline
Questionnaire• Risk factors for BV: race, prior and current sexual activity, douching, drug use, psychosocial stress measures.
• Risk factors for SAB: age, prior pregnancy information, drug use, vaginal bleeding.
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BEAR Project: Study Methods
• Follow-up data collection (Follow-up Coordinator)
–Conduct follow-up telephone interviews.
–Medical confirmation of outcomes through medical record review.
–Classify women as eligible and either a case or pregnant control.
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BEAR Project:Follow-up
Questionnaire• Determine pregnancy status at 20
weeks gestation.• Identify subsequent diagnoses of BV
and compliance with medical therapy.
• Measure other risk factors for SAB.
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BEAR Project: Study Methods
• Case: Women experiencing a spontaneous abortion during the study period (20 weeks).
• Control: Pregnant women maintaining their pregnancy through 20 weeks gestation.
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BEAR Project: Goals
• Determine the prevalence of symptomatic and asymptomatic BV among women in first trimester of pregnancy.
• Identify predictors of BV in the first trimester (ie. stress, douching, prior pregnancy outcomes).
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BEAR Project: Goals
• Examine the independent relationship between BV and spontaneous abortion.
• Assess the separate relationship between symptomatic and asymptomatic BV and spontaneous abortion.
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Bacterial Vaginosis and Pregnancy: Clinical Implications and
Current Research
Deborah B. Nelson, Ph.D.Assistant Professor
Center for Clinical Epidemiology and BiostatisticsUniversity of Pennsylvania School of Medicine