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PLoS Medicine Jul 2023Nonhygienic products for managing menstruation are reported to cause reproductive tract infections. Menstrual cups are a potential solution. We assessed whether... (Randomized Controlled Trial)
Randomized Controlled Trial
Analysis of bacterial vaginosis, the vaginal microbiome, and sexually transmitted infections following the provision of menstrual cups in Kenyan schools: Results of a nested study within a cluster randomized controlled trial.
BACKGROUND
Nonhygienic products for managing menstruation are reported to cause reproductive tract infections. Menstrual cups are a potential solution. We assessed whether menstrual cups would reduce bacterial vaginosis (BV), vaginal microbiome (VMB), and sexually transmitted infections (STIs) as studies have not evaluated this.
METHODS AND FINDINGS
A cluster randomized controlled trial was performed in 96 Kenyan secondary schools, randomized (1:1:1:1) to control, menstrual cup, cash transfer, or menstrual cup plus cash transfer. This substudy assessing the impact of menstrual cups on BV, VMB, and STIs, included 6 schools from the control (3) and menstrual cup only (3) groups, both receiving BV and STI testing and treatment at each visit. Self-collected vaginal swabs were used to measure VMB (16S rRNA gene amplicon sequencing), BV (Nugent score), and STIs. STIs were a composite of Chlamydia trachomatis and Neisseria gonorrhoeae (nucleic acid amplification test) and Trichomonas vaginalis (rapid immunochromatographic assay). Participants were not masked and were followed for 30 months. The primary outcome was diagnosis of BV; secondary outcomes were VMB and STIs. Intention-to-treat blinded analyses used mixed effects generalized linear regressions, with random effects term for school. The study was conducted between May 2, 2018, and February 7, 2021. A total of 436 participants were included: 213 cup, 223 control. There were 289 BV diagnoses: 162 among control participants and 127 among intervention participants (odds ratio 0.76 [95% CI 0.59 to 0.98]; p = 0.038). The occurrence of Lactobacillus crispatus-dominated VMB was higher among cup group participants (odds ratio 1.37 [95% CI 1.06 to 1.75]), as was the mean relative abundance of L. crispatus (3.95% [95% CI 1.92 to 5.99]). There was no effect of intervention on STIs (relative risk 0.82 [95% CI 0.50 to 1.35]). The primary limitations of this study were insufficient power for subgroup analyses, and generalizability of findings to nonschool and other global settings.
CONCLUSIONS
Menstrual cups with BV and STI testing and treatment benefitted adolescent schoolgirls through lower occurrence of BV and higher L. crispatus compared with only BV and STI testing and treatment during the 30 months of a cluster randomized menstrual cup intervention.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03051789.
Topics: Female; Adolescent; Humans; Vaginosis, Bacterial; Kenya; Menstrual Hygiene Products; RNA, Ribosomal, 16S; Sexually Transmitted Diseases; Schools; Microbiota
PubMed: 37490459
DOI: 10.1371/journal.pmed.1004258 -
Scientific Reports Jul 2022Bacterial vaginosis (BV) is a predominant vaginal disturbance that affects about 25% of childbearing-aged women. Dietary consumption may have a crucial role in vaginal...
Bacterial vaginosis (BV) is a predominant vaginal disturbance that affects about 25% of childbearing-aged women. Dietary consumption may have a crucial role in vaginal flora imbalances. This study was a hospital-based case-control study. In total, 144 incident BV cases and 151 healthy participants were recruited from the gynecology clinic in Tehran, Iran, between November 2020 and June 2021. Participants' typical diets were collected by a food frequency questionnaire. Vaginal flora was characterized based on the Amsel criteria. Factor analysis was used to pinpoint the principal dietary patterns. For logistic regression, the first tertile was assumed as a reference. Five principal dietary patterns emerged and were nominated as "Healthy diet," "Unhealthy diet," "Ovo-vegetarian diet," "Pseudo-Mediterranean diet," and "Western diet." The "Unhealthy diet" pattern were positively associated with BV (adjusted odds ratio (aOR) = 3.35; 95% confidence interval (CI) 1.41, 7.94; p: 0.006), while adherence to the "Ovo-vegetarian diet" pattern was associated with a reduced odds of BV (aOR = 0.16; 95% CI 0.07, 0.34; p < 0.001). These results provide evidence that following the "unhealthy diet" pattern may lead to developing BV, and plant-based eating patterns may be associated with reduced BV odds.
Topics: Aged; Case-Control Studies; Diet, Western; Female; Humans; Iran; Risk Factors; Vagina; Vaginosis, Bacterial
PubMed: 35842517
DOI: 10.1038/s41598-022-16505-8 -
Infection and Immunity May 2023species are associated with bacterial vaginosis (BV) and have been investigated as etiological agents of the condition. Nonetheless, the isolation of this taxon from... (Review)
Review
species are associated with bacterial vaginosis (BV) and have been investigated as etiological agents of the condition. Nonetheless, the isolation of this taxon from healthy individuals has raised important questions regarding its etiological role. Recently, using advanced molecular approaches, the genus was expanded to include several different species that exhibit differences in virulence potential. Understanding the significance of these different species with respect to mucosal immunity and the pathogenesis and complications of BV could be crucial to solving the BV enigma. Here, we review key findings regarding the unique genetic and phenotypic diversity within this genus, virulence factors, and effects on mucosal immunity as they stand. We also comment on the relevance of these findings to the proposed role of in BV pathogenesis and in reproductive health and identify key gaps in knowledge that should be explored in the future.
Topics: Humans; Female; Vaginosis, Bacterial; Gardnerella; Immunity, Mucosal; Virulence Factors; Gardnerella vaginalis; Vagina
PubMed: 37071014
DOI: 10.1128/iai.00390-22 -
American Journal of Obstetrics and... May 2019Bacterial vaginosis is 1 of the most common vaginal conditions in the United States. Recent studies have suggested that obese women have an abnormal microbiota...
BACKGROUND
Bacterial vaginosis is 1 of the most common vaginal conditions in the United States. Recent studies have suggested that obese women have an abnormal microbiota reminiscent of bacterial vaginosis; however, few studies have investigated the prevalence of bacterial vaginosis in overweight and obese populations. Moreover, despite the increased prevalence of obesity and bacterial vaginosis in black women, it is not known whether racial disparities exist in the relationship between obesity and bacterial vaginosis.
OBJECTIVE
The objective of this study was to examine the relationship between body mass index and bacterial vaginosis as determined by Nugent score and to determine the influence of race in this context.
STUDY DESIGN
We performed a cross-sectional study using patient data and vaginal smears from 5918 participants of the Contraceptive CHOICE Project. Gram-stained vaginal smears were scored with the Nugent method and categorized as bacterial vaginosis-negative (Nugent score, 0-3), bacterial vaginosis-intermediate (Nugent score, 4-6), or bacterial vaginosis-positive (Nugent score, 7-10). Body mass index was determined with Centers for Disease Control and Prevention guidelines, and obese individuals were categorized as class I, II, or III obese based on National Institutes of Health and World Health Organization body mass index parameters. Linear regression was used to model mean differences in Nugent scores; Poisson regression with robust error variance was used to model prevalence of bacterial vaginosis.
RESULTS
In our cohort, 50.7% of participants were black; 41.5% were white, and 5.1% were of Hispanic ethnicity; the average age of 25.3 years old. Overall, 28.1% of participants were bacterial vaginosis-positive. Bacterial vaginosis was prevalent in 21.3% of lean, 30.4% of overweight, and 34.5% of obese women (P<.001). The distribution of bacterial vaginosis-intermediate individuals was similar across all body mass index categories. Compared with the scores of lean women, Nugent scores were highest among overweight and obese class I women (adjusted mean difference: overweight women, 0.33 [95% confidence interval, 0.14-0.51] and obese women, 0.51 [95% confidence interval, 0.29-0.72]). Consistent with this, overweight and obese women had a higher frequency of bacterial vaginosis compared with lean women, even after adjustment for variables that included race. Among white women, the prevalence of bacterial vaginosis was higher for overweight and class I and class II/III obese white women compared with lean white women, which is a phenomenon not observed among black women and suggests an effect modification.
CONCLUSION
Overweight and obese women have higher Nugent scores and a greater occurrence of bacterial vaginosis compared with lean women. Black women have a greater prevalence of bacterial vaginosis independent of their body mass index compared with white women.
Topics: Adult; Black People; Cross-Sectional Studies; Female; Humans; Obesity; Risk Factors; Vaginal Smears; Vaginosis, Bacterial; White People; Young Adult
PubMed: 30707966
DOI: 10.1016/j.ajog.2019.01.229 -
AIDS (London, England) Jul 2008To assess and summarize the published literature on the extent to which bacterial vaginosis may increase the risk of HIV acquisition. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
To assess and summarize the published literature on the extent to which bacterial vaginosis may increase the risk of HIV acquisition.
DESIGN
Meta-analysis of published studies.
METHODS
Medline and other electronic databases were systematically searched for eligible publications. The association between bacterial vaginosis and incident HIV was separately analyzed from that between bacterial vaginosis and prevalent HIV. The latter was further analyzed, stratified by bacterial vaginosis diagnostic method, HIV risk profile of the study population, and whether or not adjusted estimates were presented.
RESULTS
Twenty-three eligible publications were identified, including a total of 30,739 women. Bacterial vaginosis was associated with an increased risk of HIV acquisition in HIV-incidence studies (relative risk = 1.6, 95% confidence interval: 1.2, 2.1). All but one of 21 HIV-prevalence studies reported estimates above the null. The latter results were heterogeneous and showed some evidence of funnel plot asymmetry, precluding the estimation of a single summary measure. The association between bacterial vaginosis and HIV in prevalence studies appeared stronger for women without high-risk sexual behavior.
CONCLUSION
Bacterial vaginosis was consistently associated with an increased risk of HIV infection. High bacterial vaginosis prevalence may result in a high number of HIV infections being attributable to bacterial vaginosis. More prospective studies are needed to accurately evaluate the role of bacterial vaginosis in HIV acquisition in low-risk versus high-risk women. Furthermore, randomized clinical trials may be worth considering to determine the effect of bacterial vaginosis control measures on HIV acquisition.
Topics: Adolescent; Adult; Aged; Female; HIV Infections; Humans; Incidence; Middle Aged; Prevalence; Risk-Taking; Sexual Behavior; Vaginosis, Bacterial
PubMed: 18614873
DOI: 10.1097/QAD.0b013e3283021a37 -
International Journal of Molecular... Dec 2023Previously established diagnostic approaches for the diagnosis of bacterial vaginosis (BV), such as the Amsel criteria or the Nugent scoring system, do not always... (Review)
Review
Previously established diagnostic approaches for the diagnosis of bacterial vaginosis (BV), such as the Amsel criteria or the Nugent scoring system, do not always correspond to modern trends in understanding the etiology and pathogenesis of polymicrobial conditions. Inter-examiner variability and interpretation of data complicate the wet mount microscopy method. Gram staining of smears does not always provide reliable information regarding bacterial taxa, biofilms, or vaginal dysbiosis. Therefore, the introduction of molecular techniques into clinical practice is extremely relevant. Molecular approaches allow not only the diagnosis of BV but also provide an assessment of microbial composition, which is especially important in the differential diagnosis of vaginal infections. The current review represents an expert opinion on BV diagnosis and is based on extensive experience in the field of vaginal infection diagnosis and treatment.
Topics: Female; Humans; Vaginosis, Bacterial; Molecular Diagnostic Techniques; Vagina; Biofilms; Diagnosis, Differential
PubMed: 38203620
DOI: 10.3390/ijms25010449 -
Journal of Clinical Microbiology Jan 2021Bacterial vaginosis (BV) is caused by the excessive and imbalanced growth of bacteria in vagina, affecting 30 to 50% of women. Gram staining followed by Nugent scoring...
Bacterial vaginosis (BV) is caused by the excessive and imbalanced growth of bacteria in vagina, affecting 30 to 50% of women. Gram staining followed by Nugent scoring based on bacterial morphotypes under the microscope is considered the gold standard for BV diagnosis; this method is often labor-intensive and time-consuming, and results vary from person to person. We developed and optimized a convolutional neural network (CNN) model and evaluated its ability to automatically identify and classify three categories of Nugent scores from microscope images. The CNN model was first established with a panel of microscopic images with Nugent scores determined by experts. The model was trained by minimizing the cross-entropy loss function and optimized by using a momentum optimizer. The separate test sets of images collected from three hospitals were evaluated by the CNN model. The CNN model consisted of 25 convolutional layers, 2 pooling layers, and a fully connected layer. The model obtained 82.4% sensitivity and 96.6% specificity with the 5,815 validation images when altered vaginal flora and BV were considered the positive samples, which was better than the rates achieved by top-level technologists and obstetricians in China. The capability of our model for generalization was so strong that it exhibited 75.1% accuracy in three categories of Nugent scores on the independent test set of 1,082 images, which was 6.6% higher than the average of three technologists, who are hold bachelor's degrees in medicine and are qualified to make diagnostic decisions. When three technologists ran one specimen in triplicate, the precision of three categories of Nugent scores was 54.0%. One hundred three samples diagnosed by two technologists on different days showed a repeatability of 90.3%. The CNN model outperformed human health care practitioners in terms of accuracy and stability for three categories of Nugent score diagnosis. The deep learning model may offer translational applications in automating diagnosis of bacterial vaginosis with proper supporting hardware.
Topics: Bacteria; China; Female; Humans; Neural Networks, Computer; Vagina; Vaginosis, Bacterial
PubMed: 33148709
DOI: 10.1128/JCM.02236-20 -
The Malaysian Journal of Pathology Dec 2018Gardnerella vaginalis (GV) is a facultatively anaerobic gram-variable bacillus and is the major organism involved in bacterial vaginosis. GV-associated bacterial... (Review)
Review
Gardnerella vaginalis (GV) is a facultatively anaerobic gram-variable bacillus and is the major organism involved in bacterial vaginosis. GV-associated bacterial vaginosis has been associated with adverse pregnancy outcomes include preterm parturition and subclinical chorioamnionitis. Inflammatory response induced by GV presents paediatric problems as well. Studies had shown that increased levels of proinflammatory cytokines include TNF-α, IL-1β and IL-6 following fetal inflammatory response syndrome secondary to GV-induced intrauterine infection may result in the development of periventricular leukomalacia and bronchopulmonary dysplasia in the infected fetus. There is increasing evidence that GV-associated BV infection serves as a risk factor for long-term neurological complications, such as cerebral palsy and learning disability. GV is fastidious and could elude conventional detection methods such as bacterial cultures. With current more sophisticated molecular biology detection methods, its role and pathogenic effects have been shown to have a greater impact on intrauterine inflammation and fetal/neonatal infection. This review gives an overview on the characteristics of GV and its virulence properties. Its detrimental role in causing unfavourable GV-related perinatal outcomes, with emphasis on the possible mechanistic pathways is discussed. The discovery of disease mechanisms allows the building of a strong platform where further research on innovative therapies can be based on, for instance, an anti-TLR monoclonal antibody as therapeutic agent to halt inflammation-precipitate adverse perinatal outcomes.
Topics: Female; Gardnerella vaginalis; Gram-Positive Bacterial Infections; Humans; Infant, Newborn; Pregnancy; Vaginosis, Bacterial
PubMed: 30580358
DOI: No ID Found -
Human Reproduction (Oxford, England) Apr 2021Is bacterial vaginosis (BV) associated with fecundability?
STUDY QUESTION
Is bacterial vaginosis (BV) associated with fecundability?
SUMMARY ANSWER
Women with BV may be at increased risk for sub-fecundity.
WHAT IS KNOWN ALREADY
While BV has been associated with poor IVF outcomes, the association between vaginal microbiota disruption and non-medically assisted conception has not been thoroughly explored.
STUDY DESIGN, SIZE, DURATION
Kenyan women with fertility intent were enrolled in prospective cohort that included monthly preconception visits with vaginal fluid specimen collection and pregnancy testing. Four hundred fifty-eight women attempting pregnancy for ≤3 menstrual cycles at enrollment were eligible for this fecundability analysis.
PARTICIPANTS/MATERIALS, SETTING, METHODS
At monthly preconception visits, participants reported the first day of last menstrual period and sexual behavior, underwent pregnancy testing and provided vaginal specimens. Discrete time proportional probabilities models were used to estimate fecundability ratios (FRs) and 95% CI in menstrual cycles with and without BV (Nugent score ≥ 7) at the visit prior to each pregnancy test. We also assessed the association between persistent BV (BV at two consecutive visits) and fecundability.
MAIN RESULTS AND THE ROLE OF CHANCE
Participants contributed 1376 menstrual cycles; 18.5% (n = 255) resulted in pregnancy. After adjusting for age, frequency of condomless sex and study site, BV at the visit prior to pregnancy testing was associated with a 17% lower fecundability (adjusted FR (aFR) 0.83, 95% CI 0.6-1.1). Persistent BV was associated with a 43% reduction in fecundability compared to cycles characterized by optimal vaginal health (aFR 0.57, 95% CI 0.4-0.8).
LIMITATIONS, REASONS FOR CAUTION
Detection of vaginal microbiota disruption using Gram stain and a point-of-care test for elevated sialidase identified a non-optimal vaginal environment, but these non-specific methods may miss important relationships that could be identified by characterizing individual vaginal bacteria and bacterial communities using molecular methods. In addition, results may be subject to residual confounding by condomless sex as this was reported for the prior month rather than for the fertile window during each cycle.
WIDER IMPLICATIONS OF THE FINDINGS
Given the high global prevalence of BV and infertility, an association between BV and reduced fecundability could have important implications for a large number of women who wish to conceive. Multi-omics approaches to studying the vaginal microbiota may provide key insights into this association and identify potential targets for intervention.
STUDY FUNDING/COMPETING INTEREST(S)
This work was supported by a National Institutes of Health grant (NICHD R01 HD087346-R.S.M.). R.S.M. received additional support for mentoring (NICHD K24 HD88229). E.M.L. was supported by pre- and post-doctoral fellowships (NIAID T32 AI07140, NICHD F32 HD100202). Data collection and management were made possible using REDCap electronic data capture tools hosted at the University of Washington's Institute of Translational Health Science supported by grants from NCATS/NIH (UL1 TR002319). The content of this paper is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. R.S.M. receives research funding, paid to the University of Washington, from Hologic Corporation, and has received honoraria for consulting from Lupin Pharmaceuticals. L.E.M. receives research funding, paid to the University of Washington, from Hologic Corporation, and has received honoraria for service on scientific advisory boards from Hologic and Nabriva Therapeutics.
TRIAL REGISTRATION NUMBER
N/A.
Topics: Cohort Studies; Female; Fertility; Humans; Kenya; Pregnancy; Prospective Studies; Vaginosis, Bacterial
PubMed: 33594429
DOI: 10.1093/humrep/deab002 -
The Brazilian Journal of Infectious... 2023The factors associated with bacterial vaginosis in women with homosexual, bisexual and heterosexual practices are still poorly explored. Thus, the aim of this study was...
BACKGROUND
The factors associated with bacterial vaginosis in women with homosexual, bisexual and heterosexual practices are still poorly explored. Thus, the aim of this study was to analyze the factors associated with bacterial vaginosis in women with different sexual practices.
METHODS
Cross-sectional study that included 453 women, 149 Women with Homosexual practice (WSW); 80 bisexual Women (WSWM) and 224 Women with heterosexual practice (WSM). The diagnosis of bacterial vaginosis was performed by microscopic examination of the vaginal smears stained by Gram method and classified according to the Nugent et al. (1991) score. Data analysis was performed by Cox multiple regression.
RESULTS
Bacterial vaginosis was associated to years of education among WSW (0.91 [95% CI 0.82‒0.99]; p = 0.048) and non-white skin color (2.34 [95% CI 1.05‒5.19]; p = 0.037) between WSWM. Changing partners in the last 3-months (2.09 [95% CI 1.14‒3.82]; p = 0.017), inconsistent use of condoms (2.61 [95% CI 1.10‒6.20]; p = 0.030) and positive diagnosis of Chlamydia trachomatis (2.40 [95% CI 1.01‒5.73]; p = 0.048) were associated with bacterial vaginoses only in WSH.
CONCLUSIONS
The factors associated to bacterial vaginosis differ between different sexual practices, suggesting that the type of sexual partner may influence the risk of developing this classic dysbiosis.
Topics: Female; Humans; Vaginosis, Bacterial; Heterosexuality; Cross-Sectional Studies; Sexual Behavior; Sexual Partners; Sexual and Gender Minorities; Risk Factors
PubMed: 36977500
DOI: 10.1016/j.bjid.2023.102760