Vulvovaginal yeast infections during pregnancy and perinatal outcomes: systematic review and meta-analysis.

BACKGROUND Vulvovaginal yeast infections in pregnancy are common and can cause extensive inflammation, which could contribute to adverse pregnancy outcomes. Symptomatic yeast infections are likely to cause more inflammation than asymptomatic. The objective of this study was to investigate associations between symptomatic and asymptomatic vulvovaginal yeast infections in pregnancy and perinatal outcomes. METHODS We did a systematic review and searched eight databases until 01 July 2022. We included studies reporting on pregnant women with and without laboratory confirmed vulvovaginal yeast infection and preterm birth or eight other perinatal outcomes. We used random effects meta-analysis to calculate summary odds ratios (OR), 95% confidence intervals (CI) and prediction intervals for the association between yeast infection and outcomes. We described findings from studies with multivariable analyses. We assessed the risk of bias using published tools. RESULTS We screened 3909 references and included 57 studies. Only 22/57 studies reported information about participant vulvovaginal symptoms. Preterm birth was an outcome in 35/57 studies (49,161 women). In 32/35 studies with available data, the summary OR from univariable analyses was 1.01 (95% CI 0.84-1.21, I2 60%, prediction interval 0.45-2.23). In analyses stratified by symptom status, we found ORs of 1.44 (95% CI 0.92-2.26) in two studies with ≥ 50% symptomatic participants, 0.84 (95% CI 0.45-1.58) in seven studies with < 50% symptomatic participants, and 1.12 (95% CI 0.94-1.35) in four studies with asymptomatic participants. In three studies with multivariable analysis, adjusted ORs were greater than one but CIs were compatible with there being no association. We did not find associations between vulvovaginal yeast infection and any secondary outcome. Most studies were at high risk of bias in at least one domain and only three studies controlled for confounding. CONCLUSIONS We did not find strong statistical evidence of an increased risk for preterm birth or eight other adverse perinatal outcomes, in pregnant women with either symptomatic or asymptomatic vulvovaginal yeast infection. The available evidence is insufficient to make recommendations about testing and treatment of vulvovaginal yeast infection in pregnancy. Future studies should assess vulvovaginal symptoms, yeast organism loads, concomitant vaginal or cervical infections, and microbiota using state-of-the-art diagnostics. SYSTEMATIC REVIEW REGISTRATION PROSPERO CRD42020197564

Low prevalence of Schistosoma haematobium infection in pregnant women in Buffalo City district

DATA AVAILABILITY : Data supporting the findings of this study are available from the corresponding author, R.P.H.P., on request.No abstract available.The National Institutes of Health.http://www.sajid.co.zaam2024Medical MicrobiologySDG-03:Good heatlh and well-bein

Vulvovaginal yeast infections during pregnancy and perinatal outcomes : systematic review and meta-analysis

AVAILABILITY OF DATA AND MATERIALS : All data generated or analysed during this study are included in this published article, its supplementary information files or can be obtained via request to the corresponding author.SUPPLEMENTARY INFORMATION : ADDITIONAL FILE 1. Search strategy. Search terms used for the literature search in eight databases. ADDITIONAL FILE 2. REDCap data extraction forms. Data extraction forms on REDCap which were designed and used to extract data from published articles for our systematic review. ADDITIONAL FILE 3. Forest plots of stratified meta-analyses. Forest plots of meta-analyses about vulvovaginal yeast infection and preterm birth stratified by study design, diagnostic method used, income setting, and time of testing. ADDITIONAL FILE 4. Forest plots of secondary outcomes. Forest plots of meta-analyses about vulvovaginal yeast infection and spontaneous abortion, stillbirth, preterm premature rupture of membranes, premature rupture of membranes, low birth weight, inflammation of the placenta or uterus. ADDITIONAL FILE 5. Summary of risk of bias assessment for cohort studies, cross-sectional studies, clinical trials, and case–control studies. ADDITIONAL FILE 6. Funnel plots of secondary outcomes preterm premature rupture of membranes and premature rupture of membranes.BACKGROUND : Vulvovaginal yeast infections in pregnancy are common and can cause extensive inflammation, which could contribute to adverse pregnancy outcomes. Symptomatic yeast infections are likely to cause more inflammation than asymptomatic. The objective of this study was to investigate associations between symptomatic and asymptomatic vulvovaginal yeast infections in pregnancy and perinatal outcomes. METHODS : We did a systematic review and searched eight databases until 01 July 2022. We included studies reporting on pregnant women with and without laboratory confirmed vulvovaginal yeast infection and preterm birth or eight other perinatal outcomes. We used random effects meta-analysis to calculate summary odds ratios (OR), 95% confidence intervals (CI) and prediction intervals for the association between yeast infection and outcomes. We described findings from studies with multivariable analyses. We assessed the risk of bias using published tools. RESULTS : We screened 3909 references and included 57 studies. Only 22/57 studies reported information about participant vulvovaginal symptoms. Preterm birth was an outcome in 35/57 studies (49,161 women). In 32/35 studies with available data, the summary OR from univariable analyses was 1.01 (95% CI 0.84–1.21, I2 60%, prediction interval 0.45–2.23). In analyses stratified by symptom status, we found ORs of 1.44 (95% CI 0.92–2.26) in two studies with ≥ 50% symptomatic participants, 0.84 (95% CI 0.45–1.58) in seven studies with < 50% symptomatic participants, and 1.12 (95% CI 0.94–1.35) in four studies with asymptomatic participants. In three studies with multivariable analysis, adjusted ORs were greater than one but CIs were compatible with there being no association. We did not find associations between vulvovaginal yeast infection and any secondary outcome. Most studies were at high risk of bias in at least one domain and only three studies controlled for confounding. CONCLUSIONS : We did not find strong statistical evidence of an increased risk for preterm birth or eight other adverse perinatal outcomes, in pregnant women with either symptomatic or asymptomatic vulvovaginal yeast infection. The available evidence is insufficient to make recommendations about testing and treatment of vulvovaginal yeast infection in pregnancy. Future studies should assess vulvovaginal symptoms, yeast organism loads, concomitant vaginal or cervical infections, and microbiota using state-of-the-art diagnostics.An MD-PhD scholarship from the Swiss National Science Foundation, a Swiss National Science Foundation, a Swiss government excellence scholarship and the SSPH + Global PhD Fellowship Programme in Public Health Sciences of the Swiss School of Public Health.https://bmcwomenshealth.biomedcentral.comam2024Medical MicrobiologySDG-03:Good heatlh and well-bein

Usability of a novel lateral flow assay for the point-of-care detection of Neisseria gonorrhoeae : a qualitative time-series assessment among healthcare workers in South Africa

DATA AVAILABILITY STATEMENT : The dataset for the System Usability Scale (SUS) has been uploaded to the Open Science Framework data repository. The identifier for this dataset is DOI 10.17605/OSF.IO/ EFVHS. The qualitative data are not publicly available due to privacy or ethical restrictions as ensured by participant informed consent and South Africa’s protection of personal information act (POPIA). The relevant contact for any data inquiries and access upon reasonable request is: Freedom Mukomana Data Manager, Foundation for Professional DevelopmentSUPPORTING INFORMATION : FILE S1. FIND NG-LFA testing and reader- set up instructions (QuickCards). FILE S2. Study participation flow for time series assessment: SUS surveys and IDIs.Accurate and user-friendly rapid point-of-care diagnostic tests (POCT) are needed to optimize treatment of Neisseria gonorrhoeae, especially in low-resource settings where syndromic management is the standard of care for sexually transmitted infections. This study aimed to assess the acceptability and usability of a novel lateral flow assay and portable reader for the point-of-care detection of N. gonorrhoeae infection (NG-LFA). This mixedmethods study was conducted as part of a diagnostic performance and usability evaluation of a prototype NG-LFA for detection of N. gonorrhoeae in symptomatic men and women at primary healthcare facilities in the Buffalo City Metro, South Africa. The Standardized System Usability Scale (SUS) was administered, and in-depth interviews were conducted among healthcare professionals (HCPs) and fieldworkers (FWs) at pre-implementation, initial use and 3- and 6-month study implementation to assess user expectations, practical experience, and future implementation considerations for the NG-LFA. Data collection and analysis was guided by the Health Technology Adoption Framework, including new health technology attributes, learnability, satisfaction, and suitability. The framework was adapted to include perceived durability. A total of 21 HCPs and FWs were trained on the NG-LFA use. SUS scores showed good to excellent acceptability ranging from 78.8–90.6 mean scores between HCPs and FWs across study time points. All transcripts were coded using Dedoose and qualitative findings were organized by learnability, satisfaction, suitability, and durability domains. Usability themes are described for each time point. Initial insecurity dissipated and specimen processing dexterity with novel POCT technology was perfected over time especially amongst FWs through practical learning and easy-to-use instructions (learnability). Participants experienced both positive and negative test results, yielding perceived accuracy and minimal testing challenges overall (satisfaction). By 3- and 6-month use, both HCPs and FWs found the NG-LFA convenient to use in primary health care facilities often faced with space constraints and outlined perceived benefits for patients (suitability and durability). Findings show that the NG-LFA device is acceptable and usable even amongst paraprofessionals. High SUS scores and qualitative findings demonstrate high learnability, ease-of-use and suitability that provide valuable information for first-step scale-up requirements at primary healthcare level. Minor prototype adjustments would enhance robustness and durability aspects.The performance evaluation was funded by a sub-award from the Global Antimicrobial Resistance Innovation Fund (GAMRIF) via FIND. (Funder website: https://www.gov.uk/government/groups/theglobal- amr-innovation-fund).https://journals.plos.org/plosone/am2024Medical MicrobiologySDG-03:Good heatlh and well-bein

A call to standardize the definition and method of assessing women for vaginal discharge syndrome in pregnancy

No abstract available.The National Institute of Allergy and Infectious Diseases of the National Institutes of Health.https://academic.oup.com/ofidhj2024Medical MicrobiologyNon

Vulvovaginal yeast infections during pregnancy and perinatal outcomes: systematic review and meta-analysis

Background: Vulvovaginal yeast infections in pregnancy are common and can cause extensive inflammation, which could contribute to adverse pregnancy outcomes. Symptomatic yeast infections are likely to cause more inflammation than asymptomatic. The objective of this study was to investigate associations between symptomatic and asymptomatic vulvovaginal yeast infections in pregnancy and perinatal outcomes. Methods: We did a systematic review and searched eight databases until 01 July 2022. We included studies reporting on pregnant women with and without laboratory confirmed vulvovaginal yeast infection and preterm birth or eight other perinatal outcomes. We used random effects meta-analysis to calculate summary odds ratios (OR), 95% confidence intervals (CI) and prediction intervals for the association between yeast infection and outcomes. We described findings from studies with multivariable analyses. We assessed the risk of bias using published tools. Results: We screened 3909 references and included 57 studies. Only 22/57 studies reported information about participant vulvovaginal symptoms. Preterm birth was an outcome in 35/57 studies (49,161 women). In 32/35 studies with available data, the summary OR from univariable analyses was 1.01 (95% CI 0.84–1.21, I 2 60%, prediction interval 0.45–2.23). In analyses stratified by symptom status, we found ORs of 1.44 (95% CI 0.92–2.26) in two studies with ≥ 50% symptomatic participants, 0.84 (95% CI 0.45–1.58) in seven studies with < 50% symptomatic participants, and 1.12 (95% CI 0.94–1.35) in four studies with asymptomatic participants. In three studies with multivariable analysis, adjusted ORs were greater than one but CIs were compatible with there being no association. We did not find associations between vulvovaginal yeast infection and any secondary outcome. Most studies were at high risk of bias in at least one domain and only three studies controlled for confounding. Conclusions: We did not find strong statistical evidence of an increased risk for preterm birth or eight other adverse perinatal outcomes, in pregnant women with either symptomatic or asymptomatic vulvovaginal yeast infection. The available evidence is insufficient to make recommendations about testing and treatment of vulvovaginal yeast infection in pregnancy. Future studies should assess vulvovaginal symptoms, yeast organism loads, concomitant vaginal or cervical infections, and microbiota using state-of-the-art diagnostics. Systematic review registration: PROSPERO CRD42020197564

Implementation considerations for a point-of-care Neisseria gonorrhoeae rapid diagnostic test at primary healthcare level in South Africa : a qualitative study

ADDITIONAL FILE 1 : IDI protocols. Interview protocols used in this study during the pre-implementation, initial use, 3-month (mid-assessment) and 6-month (post-evaluation) implementation phase.ADDITIONAL TABLE 1 : Consolidated criteria for reporting qualitative studies (COREQ): 32-item checklist for interviews and focus groups.ADDITIONAL TABLE 2 : NPT Constructs as defined for the implementation of the NG-LFA.BACKGROUND : South Africa maintains an integrated health system where syndromic management of sexually transmitted infections (STI) is the standard of care. An estimated 2 million cases of Neisseria gonorrhoeae (N. gonorrhoeae) occur in South Africa every year. Point-of-care diagnostic tests (POCT) may address existing STI control limitations such as overtreatment and missed cases. Subsequently, a rapid lateral flow assay with fluorescence-based detection (NG-LFA) with a prototype reader was developed for N. gonorrhoeae detection showing excellent performance and high usability; however, a better understanding is needed for device implementation and integration into clinics. METHODS : A qualitative, time-series assessment using 66 in-depth interviews was conducted among 25 trained healthcare workers involved in the implementation of the NG-LFA. Findings were informed by the Normalization Process Theory (NPT) as per relevant contextual (strategic intentions, adaptive execution, and negotiation capacity) and procedural constructs (coherence, cognitive participation, collective action, reflexive monitoring) to examine device implementation within primary healthcare levels. Interviews were audio-recorded, transcribed, and then analyzed using a thematic approach guided by NPT to interpret results. RESULTS : Overall, healthcare workers agreed that STI POCT could guide better STI clinical decision-making, with consideration for clinic integration such as space constraints, patient flow, and workload. Perceived NG-LFA benefits included enhanced patient receptivity and STI knowledge. Further, healthcare workers reflected on the suitability of the NG-LFA given current limitations with integrated primary care. Recommendations included sufficient STI education, and appropriate departments for first points of entry for STI screening. CONCLUSIONS : The collective action and participation by healthcare workers in the implementation of the NG-LFA revealed adaptive execution within the current facility environment including team compositions, facility-staff receptivity, and STI management experiences. User experiences support future clinic service integration, highlighting the importance of further assessing patient-provider communication for STI care, organizational readiness, and identification of relevant departments for STI screening.Sub-award via FIND (primary recipient Cecilia Ferreyra), from the Global Antimicrobial Resistance Innovation Fund (GAMRIF) (https://www.gov.uk/government/groups/theglobal-amr-innovation-fund).https://bmchealthservres.biomedcentral.comhj2024Medical MicrobiologySDG-03:Good heatlh and well-bein

Genital tract infections, the vaginal microbiome and gestational age at birth among pregnant women in South Africa : a cohort study protocol

DATA STATEMENT : The research team will prepare datasets used in analyses, in accordance with data sharing requirements of open access journals in which manuscripts are published and in compliance with local Protection of Personal Information Act requirements. These data files will be archived with codebooks as .csv documents or R datasets and stored in REDCap. The final data files will not contain any personal identifying information of participants.INTRODUCTION : Preterm birth complications are the most common cause of death in children under 5 years. The presence of multiple microorganisms and genital tract inflammation could be the common mechanism driving early onset of labour. South Africa has high levels of preterm birth, genital tract infections and HIV infection among pregnant women. We plan to investigate associations between the presence of multiple lower genital tract microorganisms in pregnancy and gestational age at birth. METHODS AND ANALYSIS : This cohort study enrols around 600 pregnant women at one public healthcare facility in East London, South Africa. Eligible women are ≥18 years and at <27 weeks of gestation, confirmed by ultrasound. At enrolment and 30–34 weeks of pregnancy, participants receive on-site tests for Chlamydia trachomatis and Neisseria gonorrhoeae, with treatment if test results are positive. At these visits, additional vaginal specimens are taken for: PCR detection and quantification of Trichomonas vaginalis, Candida spp., Mycoplasma genitalium, M. hominis, Ureaplasma urealyticum and U. parvum; microscopy and Nugent scoring; and for 16S ribosomal RNA gene sequencing and quantification. Pregnancy outcomes are collected from a postnatal visit and birth registers. The primary outcome is gestational age at birth. Statistical analyses will explore associations between specific microorganisms and gestational age at birth. To explore the association with the quantity of microorganisms, we will construct an index of microorganism load and use mixed-effects regression models and classification and regression tree analysis to examine which combinations of microorganisms contribute to earlier gestational age at birth. ETHICS AND DISSEMINATION : This protocol has approvals from the University of Cape Town Research Ethics Committee and the Canton of Bern Ethics Committee. Results from this study will be uploaded to preprint servers, submitted to open access peer-reviewed journals and presented at regional and international conferences. TRIAL REGISTRATION NUMBER : NCT06131749; Pre-results.An MD-PhD scholarship from the Swiss National Science Foundation, the Swiss National Science Foundation and the US National Institutes of Health.http://bmjopen.bmj.comam2024Medical MicrobiologySDG-03:Good heatlh and well-bein

Genital tract infections, the vaginal microbiome and gestational age at birth among pregnant women in South Africa: a cohort study protocol

Introduction Preterm birth complications are the most common cause of death in children under 5 years. The presence of multiple microorganisms and genital tract inflammation could be the common mechanism driving early onset of labour. South Africa has high levels of preterm birth, genital tract infections and HIV infection among pregnant women. We plan to investigate associations between the presence of multiple lower genital tract microorganisms in pregnancy and gestational age at birth. Methods and analysis This cohort study enrols around 600 pregnant women at one public healthcare facility in East London, South Africa. Eligible women are ≥18 years and at <27 weeks of gestation, confirmed by ultrasound. At enrolment and 30-34 weeks of pregnancy, participants receive on-site tests for Chlamydia trachomatis and Neisseria gonorrhoeae, with treatment if test results are positive. At these visits, additional vaginal specimens are taken for: PCR detection and quantification of Trichomonas vaginalis, Candida spp., Mycoplasma genitalium, M. hominis, Ureaplasma urealyticum and U. parvum; microscopy and Nugent scoring; and for 16S ribosomal RNA gene sequencing and quantification. Pregnancy outcomes are collected from a postnatal visit and birth registers. The primary outcome is gestational age at birth. Statistical analyses will explore associations between specific microorganisms and gestational age at birth. To explore the association with the quantity of microorganisms, we will construct an index of microorganism load and use mixed-effects regression models and classification and regression tree analysis to examine which combinations of microorganisms contribute to earlier gestational age at birth. Ethics and dissemination This protocol has approvals from the University of Cape Town Research Ethics Committee and the Canton of Bern Ethics Committee. Results from this study will be uploaded to preprint servers, submitted to open access peer-reviewed journals and presented at regional and international conferences. Trial registration number NCT06131749; Pre-results