Vaginitis Research Articles

Phase III Study to Evaluate the Efficacy and Safety of Two Novel Fixed-Dose Vaginal Ovule Formulations in the Treatment of Various Vaginal Infections: One-Shot Study Running Title: Phase III study of two novel vaginal ovules

Objective: This study aimed to evaluate the efficacy and safety of two novel formulations: one containing fenticonazole nitrate 600 mg + tinidazole 1000 mg + lidocaine 100 mg (Formulation A) and the other with fenticonazole nitrate 600 mg + tinidazole 2000 mg + lidocaine 100 mg (Formulation B) in the treatment of bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), trichomonas vaginitis (TV), and mixed vaginal infections (MVIs) in comparison to comparator medication (Gynomax® XL). Materials and methods: This phase III study enrolled 562 adult, pre-menopausal patients with BV, VVC, TV, or MVIs. Of these, 544 received the study medication (included in the safety analysis), and 440 completed the study (included in the efficacy analysis). Patients were randomized into Formulation A, Formulation B, or comparator medication arms. Follow-up visits were conducted two weeks post-treatment, with clinical and microbiological evaluations. Results: Initial clinical diagnoses indicated BV (62.0%), VVC (19.8%), MVIs (15.5%), and TV (2.7%). High clinical recovery rates were observed with Formulation A (96.7% of BV, 81.8% of VVC, and 96.3% of MVIs), Formulation B (97.7% of BV, 88.2% of VVC, 90.9% of MVIs), and comparator medication (98.9% of BV, 90.3% of VVC, 100.0% of MVIs). None of the patients discontinued medications due to an adverse event or intolerability. Conclusion: All formulations are considered as safe, well-tolerated, and highly effective for treating BV, VVC, and MVIs. Formulation A or B may be particularly advantageous due to anticipated greater patient compliance with their single-dose administration.

Preparation and Evaluation of Fenticonazole Nitrate Loaded Topical Emulgel for the Treatment of Cutaneous Candidiasis

Fenticonazole nitrate is a broad-spectrum antifungal agent possessing fungicidal, antiparasitic, and fungistatic activities. It is effective against various fungi, including Candida species, dermatophytes, and Trichomonas, which are associated with skin and vaginal infections. Emulgel systems have gained significant attention as topical drug delivery vehicles due to their ability to incorporate a wide range of therapeutic molecules, including both hydrophobic and hydrophilic drugs. The primary objective of this study was to develop an emulgel formulation of fenticonazole nitrate for the treatment of cutaneous candidiasis (cutaneous moniliasis). Conventional emulsions often face stability issues during manufacturing and storage, which can impact drug release patterns. To overcome these challenges, the emulsion was incorporated into a gel base to enhance stability. Emulgels offer significant advantages over traditional and newer vesicular systems, such as improved therapeutic efficacy, higher drug entrapment capacity, better physiological and biological compatibility, and enhanced stability. In this study, the primary oil-in-water (o/w) emulsion was prepared using a surfactant and co-surfactant mixture (3:1 ratio) incorporated with light liquid paraffin. After characterization and optimization, the final emulsion batch was mixed with the gelling agent HPMC K4M (1:1 ratio) to obtain the emulgel formulation. The optimized emulgel exhibited optimal drug release and satisfactory results in various evaluation parameters, making it a promising topical delivery system for fenticonazole nitrate in the treatment of cutaneous candidiasis

A cost-effectiveness analysis of the use of oral ibrexafungerp versus fluconazole for acute vulvovaginal candidiasis in the UK NHS primary care service.

Vulvovaginal Candidiasis (VVC) is a fungal infection causing inflammation of the vagina and/or the vulva. Symptoms include itching, irritation, and discharge. VVC presents commonly across primary care and, despite its mild symptoms, carries psychological burden and has a significant impact on women's quality of life. UK guidelines support treatment via oral or topical azole antifungal agents. Recent evidence attests to the superiority of novel non-azole antifungals. Thus, rigorous financial assessment of both antifungals is necessary for optimal VVC treatment allocation in UK primary care. To evaluate the cost-effectiveness of ibrexafungerp against the gold standard fluconazole as first-line treatment of VVC within the NHS. A systematic review on the efficacy of ibrexafungerp and fluconazole in acute VVC was conducted. Cost-effectiveness analysis was initiated using health outcome data from the DOVE trial, a Phase 2 RCT. Costs in pound sterling were ascertained in monetary units, and effectiveness determined as reduced need for follow-up medication. An incremental cost-effectiveness ratio of £2185.74 was determined. This suggests oral ibrexafungerp being largely more costly yet slightly more effective than fluconazole, and thus has unfavourable net benefit. Two sensitivity analyses were conducted considering follow-up medication combination and market price, which provided confidence in the calculated cost-effectiveness ratio. This analysis highlights fluconazole's cost-effectiveness in current UK guidelines and favourability.

The Effect of Instructional Guidelines on Sexual Function among Women with Vaginal Yeast Infection

The Effect of Instructional Guidelines on Sexual Function among Women with Vaginal Yeast Infection

A Review on Vaginal Infections

A Review on Vaginal Infections

Phenylacetic acid, an anti-vaginitis metabolite produced by the vaginal symbiotic bacterium Chryseobacterium gleum

The human microbiome contains genetic information that regulates metabolic processes in response to host health and disease. While acidic vaginal pH is maintained in normal conditions, the pH level increases in infectious vaginitis. We propose that this change in the vaginal environment triggers the biosynthesis of anti-vaginitis metabolites. Gene expression levels of Chryseobacterium gleum, a vaginal symbiotic bacterium, were found to be affected by pH changes. The distinctive difference in the metabolic profiles between two C. gleum cultures incubated under acidic and neutral pH conditions was suggested to be an anti-vaginitis molecule, which was identified as phenylacetic acid (PAA) by spectroscopic data analysis. The antimicrobial activity of PAA was evaluated in vitro, showing greater toxicity toward Gardnerella vaginalis and Candida albicans, two major vaginal pathogens, relative to commensal Lactobacillus spp. The activation of myeloperoxidase, prostaglandin E2, and nuclear factor-κB, and the expression of cyclooxygenase-2 were reduced by an intravaginal administration of PAA in the vaginitis mouse model. In addition, PAA displayed the downregulation of mast cell activation. Therefore, PAA was suggested to be a messenger molecule that mediates interactions between the human microbiome and vaginal health.

Эффективность медицинских подкастов в повышении осведомленности женщин о здоровье

<p>The aim of the study was to evaluate the effectiveness of medical podcast as a novel learning tool for developing Egyptian women’s health awareness. 50 female university students were invited to participate in the study using social media advertisements. Online pretests and posttests, one based on a podcast episode regarding vaginal infections, were used to assess changes in knowledge level pre– and post–podcast listening. A second posttest was sent out 2 weeks after the first to assess knowledge retention. Results were analyzed using paired <em>t-</em>tests comparing mean scores before and after podcast. The results showed that the average test score increased by 62% (p<0.05). Furthermore, in both groups, there was no significant difference between average scores for posttest 1 versus posttest 2 written 2 weeks later suggested excellent knowledge retention. Podcast increased knowledge on gynecological diseases and is an effective learning tool for health care trainees in women's health. This study emphasizes the role of podcasts as a valuable educational resource within the society. The success of such initiatives will hopefully bolster the effort to correct the lack of provider knowledge in many diseases.</p>

Characteristics of Vaginal Microbiota of Women of Reproductive Age with Infections.

The vaginal microbiota can be classified into five major community state types (CSTs) based on the bacterial content. However, the link between different CST subtypes and vaginal infection remains unclear. Here, we analyzed 2017 vaginal microbiota samples from women of a reproductive age with vaginal infections that were published in the last decade. We found that L. iners was the most dominant in 34.8% of the vaginal samples, followed by L. crispatus (21.2%). CST I was common in healthy individuals, whereas CST III and IV were associated with dysbiosis and infection. CST III-B, IV-A, IV-B, and IV-C0 were prevalent in patients with bacterial vaginosis (BV). Based on the relative abundance of bacteria at the (sub)genus level, a random forest classifier was developed to predict vaginal infections with an area under the curve of 0.83. We further identified four modules of co-occurring bacterial taxa: L. crispatus, Gardnerella, Prevotella, and Bacteroides. The functional prediction revealed that nucleotide biosynthesis pathways were upregulated in patients with human papilloma virus, and carbohydrate degradation pathways were downregulated in patients with BV. Overall, our study identified the bacterial signatures of healthy and infected vaginal microbiota, providing unique insights into the clinical diagnosis and health status prediction of women of a reproductive age.

Let’s open our eyes to the importance of vaginal microbiota. Correlation between dysbiosis and HPV infection: A review

Infections with the human papillomavirus (HPV) are one of the most common sexually transmitted diseases and are the main cause of precancerous changes and cervical cancer development. However, mere infection does not guarantee the development of disease or carcinogenesis. For this to occur, high-risk types of HPV must integrate into the host cell genome, transitioning into a persistent form of infection. Following the discovery of risk factors for HPV infection and factors predisposing infection to a persistent form, the number of studies investigating the correlation between vaginal dysbiosis and infection has significantly increased. Numerous studies document a significant association between the state of vaginal bacterial flora and HPV infection, leading to the development of plentiful studies on infection pathogenesis, risk factors, prevention, and treatment methods using bacteria. In this paper, based on recently published studies and current state of science knowledge, we will outline the topic of vaginal microbiome, emphasize the importance of bacteria inhabiting the vagina for human health, and identify the problem of changes in vaginal microflora. We would like to contribute to the dissemination of knowledge about the vaginal microbiome and general knowledge about taking care of its health. We will also summarize available treatment methods based on bacterial environment and discuss those methods for which research is currently underway or should be initiated.

Investigation of the Microbial Content and Antimicrobial Activity of Isolates from the Vagina of Non-Pregnant Women in AL-Najaf Governorate

Introduction: Vaginal discharge is a common problem among many women and causes unpleasant odor and discomfort. Therefore, the study was conducted on a group of these women to find out the microbial content causing this problem and to conduct a drug sensitivity test. Methods and Materials: Specimens were collected from 92 non-pregnant women, aged (20-60) years, from the city of AL-Najaf in Iraq. 78 (84.78%). Results: Samples were positive, and the largest percentage of microbial content was for fungi represented by yeasts of Candida spp. in the rate of 54%. C. albicans was the most prevalent kind by 15%. The remainder is made up of non-Candida albicans kinds. Which is C. glabrata, C. Ciferrii, C. Guilliermondii, C. Tropicals, C. krusi . This was followed by gram-positive bacteria at a rate of 28%, This percentage was distributed between Streptococcus pyogenes by 15% and the rest for other types of bacteria Staphylococcus Spp. While Gram-negative bacteria accounted for the least percentage of the total positive specimens, at 18%, distributed between Klebsiella spp.13% and E. coli, 5%. As for the drug sensitivity test, C. glabrate, C. ciferrii and C. Krusi showed resistance to fluconazole (MIC= 8) and were sensitive to Voriconazole. Both Gram-positive and Gram-negative bacteria showed various drug sensitivity. Conclusion: This study showed that there are two main causes of vaginal infections: first: an overgrowth of Candida yeasts, and second: some types of bacteria, which are similar to those that cause urinary tract infections, as these bacteria are transmitted between the vagina and the urinary canal due to the closeness of the two areas to each other in women.

ACME: A Classification Model for Explaining the Risk of Preeclampsia Based on Bayesian Network Classifiers and a Non-Redundant Feature Selection Approach

While preeclampsia is the leading cause of maternal death in Guayas province (Ecuador), its causes have not yet been studied in depth. The objective of this research is to build a Bayesian network classifier to diagnose cases of preeclampsia while facilitating the understanding of the causes that generate this disease. Data for the years 2017 through 2023 were gathered retrospectively from medical histories of patients treated at “IESS Los Ceibos” hospital in Guayaquil, Ecuador. Naïve Bayes (NB), The Chow–Liu Tree-Augmented Naïve Bayes (TANcl), and Semi Naïve Bayes (FSSJ) algorithms have been considered for building explainable classification models. A proposed Non-Redundant Feature Selection approach (NoReFS) is proposed to perform the feature selection task. The model trained with the TANcl and NoReFS was the best of them, with an accuracy close to 90%. According to the best model, patients whose age is above 35 years, have a severe vaginal infection, live in a rural area, use tobacco, have a family history of diabetes, and have had a personal history of hypertension are those with a high risk of developing preeclampsia.

In-situ forming carboxymethyl chitosan hydrogel containing Paeonia suffruticosa Andr. leaf extract for mixed infectious vaginitis treatment by reshaping the micro-biota

Mixed infectious vaginitis poses a serious threat to female reproductive health due to complex pathogenic factors, a long course and easy recurrence. Currently, antibiotic-based treatment methods are facing a crisis of drug resistance and secondary dysbiosis. Exploring effective drugs for the treatment of mixed vaginitis from Paeonia suffruticosa Andr., a natural traditional Chinese medicine with a long history of medicinal use, is a feasible treatment strategy. P. suffruticosa Andr. leaf extract (PLE) has significant anti-bacterial effects due to its rich content of polyphenols and flavonoids. The polyphenols in peony leaves have the potential to make carboxymethyl chitosan form in situ gel. In the current study, PLE and carboxymethyl chitosan were combined to develop another type of natural anti-bacterial anti-oxidant hydrogel for the treatment of mixed infectious vaginitis. Through a series of characterisations, CP had a three-dimensional network porous structure with good mechanical properties, high water absorption, long retention and a slow-release drug effect. The mixed infectious vaginitis mouse model induced by a mixture of pathogenic bacteria was used to investigate the therapeutic effects of CP in vivo. The appearance of the vagina, H&E colouring of the tissue and inflammatory factors (TNF-α, IL-6) confirm the good anti-vaginal effect of CP. Therefore, CP was expected to become an ideal effective strategy to improve mixed infection vaginitis due to its excellent hydrogel performance and remarkable ability to regulate flora.

Recommended measurement instruments for genitourinary symptoms associated with menopause: the COMMA (Core outcomes in menopause) consortium.

The aim of the study is to identify appropriate definitions and patient-reported outcome measures (PROMs) for each of the eight core outcomes previously selected for genitourinary symptoms associated with menopause: pain with sex, vulvovaginal dryness, vulvovaginal discomfort or irritation, discomfort or pain when urinating, change in most bothersome symptom, distress, bother or interference of genitourinary symptoms, satisfaction with treatment, and side effects. We conducted a systematic review to identify possible definitions and PROMs, including their measurement properties. Identified definitions and relevant PROMs with acceptable measurement properties were entered into an international consensus process involving 28 participants from 10 countries to achieve final recommendations for each core outcome. A total of 87 publications reporting on 34 PROMs were identified from 21,207 publications screened. Of these 34 PROMs, 29 were not considered to sufficiently map onto the core outcomes, and 26 of these also had insufficient measurement properties. Therefore, only five PROMs corresponding to two core outcomes were considered for recommendation. We recommend the PROMIS Scale v2.0 - Sexual Function and Satisfaction: Vaginal Discomfort with Sexual Activity to measure the outcome of "pain with sexual activity" and the Day-to-Day Impact of Vaginal Aging (DIVA) Questionnaire to measure "distress, bother or interference" from genitourinary symptoms. Six definitions of "side effects" were identified and considered. We recommend that all trials report adverse events in study participants, which is a requirement of Good Clinical Practice. Suitable PROMs and definitions were identified to measure three of eight core outcomes. Because of the lack of existing measures, which align with the core outcomes and have evidence of high-quality measurement properties, future work will focus on developing or validating PROMs for the remaining five core outcomes.

Association of common maternal infections with birth outcomes: a multinational cohort study.

It is unclear whether common maternal infections during pregnancy are risk factors for adverse birth outcomes. We assessed the association between self-reported infections during pregnancy with preterm birth and small-for-gestational-age (SGA) in an international cohort consortium. Data on 120,507 pregnant women were obtained from six population-based birth cohorts in Australia, Denmark, Israel, Norway, the UK and the USA. Self-reported common infections during pregnancy included influenza-like illness, common cold, any respiratory tract infection, vaginal thrush, vaginal infections, cystitis, urinary tract infection, and the symptoms fever and diarrhoea. Birth outcomes included preterm birth, low birth weight and SGA. Associations between maternal infections and birth outcomes were first assessed using Poisson regression in each cohort and then pooled using random-effect meta-analysis. Risk ratios (RR) and 95% confidence intervals (CI) were calculated, adjusted for potential confounders. Vaginal infections (pooled RR, 1.10; 95% CI, 1.02-1.20) and urinary tract infections (pooled RR, 1.17; 95% CI, 1.09-1.26) during pregnancy were associated with higher risk of preterm birth. Similar associations with low birth weight were also observed for these two infections. Fever during pregnancy was associated with higher risk of SGA (pooled RR, 1.07; 95% CI, 1.02-1.12). No other significant associations were observed between maternal infections/symptoms and birth outcomes. Vaginal infections and urinary infections during pregnancy were associated with a small increased risk of preterm birth and low birth weight, whereas fever was associated with SGA. These findings require confirmation in future studies with laboratory-confirmed infection diagnosis.

Association between vaginal microbiota and vaginal inflammatory immune markers in postmenopausal women.

In premenopausal individuals, vaginal microbiota diversity and lack of Lactobacillus dominance are associated with greater mucosal inflammation, which is linked to a higher risk of cervical dysplasia and infections. It is not known if the association between the vaginal microbiota and inflammation is present after menopause, when the vaginal microbiota is generally higher-diversity and fewer people have Lactobacillus dominance. This is a post hoc analysis of a subset of postmenopausal individuals enrolled in a randomized trial for treatment of moderate-severe vulvovaginal discomfort that compared vaginal moisturizer, estradiol, or placebo. Vaginal fluid samples from 0, 4, and 12 weeks were characterized using 16S rRNA gene sequencing (microbiota) and MesoScale Discovery (vaginal fluid immune markers: IL-1b, IL-1a, IL-2, IL-6, IL-18, IL-10, IL-9, IL-13, IL-8, IP10, MIP1a, MIP1b, MIP3a). Global associations between cytokines and microbiota (assessed by relative abundance of individual taxa and Shannon index for alpha, or community, diversity) were explored, adjusting for treatment arm, using linear mixed models, principal component analysis, and Generalized Linear Mixed Model + Microbiome Regression-based Kernel Association Test (GLMM-MiRKAT). A total of 119 individuals with mean age of 61 years were included. At baseline, 29.5% of participants had a Lactobacillus -dominant vaginal microbiota. Across all timepoints, alpha diversity (Shannon index, P = 0.003) was highly associated with immune markers. Individual markers that were associated with Lactobacillus dominance were similar to those observed in premenopausal people: IL-10, IL-1b, IL-6, IL-8 (false discovery rate [FDR] < 0.01), IL-13 (FDR = 0.02), and IL-2 (FDR = 0.09). Over 12 weeks, change in alpha diversity was associated with change in cytokine concentration (Shannon, P = 0.018), with decreased proinflammatory cytokine concentrations observed with decreasing alpha diversity. In this cohort of postmenopausal individuals, Lactobacillus dominance and lower alpha diversity were associated with lower concentrations of inflammatory immune markers, as has been reported in premenopausal people. This suggests that after menopause lactobacilli continue to have beneficial effects on vaginal immune homeostasis, despite lower prevalence.

Abstract PO4-20-06: Impact of iatrogenic menopause on vaginal health and sexuality

Abstract Background Due to the lowering of circulating estrogens symptoms of genitourinary syndrome of menopause (GSM) may arise with premenopausal breast cancer patients who become menopausal due to breast cancer treatment. Clinical signs of GSM are i.a. vaginal dryness, dyspareunia, loss of libido, dysfunction of arousal and/or orgasm: this may negatively impact vaginal health, sexual activity and quality of life. The composition and function of the vaginal microbiome may also change due to changes of gonadal hormones during the menopausal transition. This change may contribute to vaginal discomfort and problems during sexual activity. With this prospective research we aim to uncover the relationship between vaginal health and sexuality, it gives an unique opportunity to investigate the vaginal changes and possible shift of vaginal microbiome when menopause occurs. This is a first in time study where longitudinal samples of the vaginal microbiome in one patient are investigated before and after menopause. The vaginal microbiome might be a future target to treat vaginal discomfort after treatment for breast cancer. Trial design This is a prospective minimal invasive study where participants are asked to undergo a baseline gynecologic examination, again 3 and 6 months after menopause. During this examination we measure vaginal pH, describe vaginal hydration and anatomy (using vaginal-, and vulvar assessment scale (VAS, VuAS)) and sample the vaginal microbiome (analyzed with 16S rRNA gene sequencing and quantitative real-time polymerase chain reaction (qPCR)). At the same time, a blood test is performed (Estradiol, FSH) and participants complete a survey (demographic information, medical history, current well-being using World Health Organisation- Five Well-Being Index (WHO-5), sexual functioning using the Female Sexual Functioning index (FSFI), Female Sexual Dysfunction Scale – revised (FSDS-R) and Short Sexual Functioning scale (SSFS)). Eligibility criteria - Patients (&amp;gt;18 years) with Stage I, IIA, IIB, IIIA, IIIB, IIIC breast cancer - Reproductive age or menopausal transition according to STRAW+10 criteria - Iatrogenic menopause caused by ovarian function suppression (OFS), bilateral salpingo-ovariectomy (BSO) or by starting chemotherapy - Any partner status - Latest cervical cytology is normal - No prior history of hysterectomy - Patients who take oral contraceptives or have a Levonorgestrel- containing IUD can participate. Oral contraceptives should be stopped or the Levonorgestrel-containing IUD should be removed before systemic breast cancer therapy Specific aims To accurately describe what vaginal changes occur during breast cancer treatment To evaluate if the onset of menopause is related to changes in vaginal microbiome To evaluate if there is a relation between the objective vaginal changes and the subjective complaints related to GSM To evaluate if there is a relation between the objective vaginal changes and a possible alteration in sexuality Statistical methods Using multiple comparison procedures in ANOVA (analysis of Variance) model, the clinical findings (VAS, VuAS, pH, composition of microbiome) and validated questionnaires (WHO-5, FSFI, FSDR-r, SSFS) are linked to analyze if vaginal changes are related to changes in sexual wellbeing. The interpretation of the results of this investigation should be interpreted with caution due to the explorative nature of the study. Present accrual/Target accrual 23/60 participants are included (JULY 2023) Citation Format: Nynke Willers, Sileny Han, Patrick Neven, Paul Enzlin, Sarah Lebeer, Sarah Ahannach. Impact of iatrogenic menopause on vaginal health and sexuality [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-20-06.

Efficacy of Dequalinium Chloride vs Metronidazole for the Treatment of Bacterial Vaginosis

Bacterial vaginosis (BV) is a common cause of vaginal infection. First-line treatments of BV are metronidazole and clindamycin. Due to the increase in antibiotic resistance, effective nonantibiotic treatments for BV are needed. To examine whether dequalinium chloride, a broad-spectrum antiseptic, is noninferior to oral metronidazole for the treatment of BV. This phase 4, multicenter, triple-blind, double-dummy, parallel, noninferiority randomized clinical trial was conducted from July 29, 2021, to August 25, 2022, with a 1-month follow-up. Participants were premenopausal women 18 years or older with BV from 11 gynecologic practices and 1 hospital in Poland, Slovakia, and the Czech. Patients were randomized to treatment with dequalinium chloride vaginal tablets (10 mg once daily for 6 days) or oral metronidazole (500 mg twice daily for 7 days). Double-dummy medication kits contained vaginal and oral tablets with placebo and active medication. The main outcome was the noninferiority margin (of 15 percentage points) in the absolute difference in clinical cure rates between dequalinium chloride and metronidazole 7 to 11 days after start of treatment (visit 1). Noninferiority was met if the lower 95% CI for the difference in clinical cure rate was less than 15 percentage points at visit 1. A total of 147 women (mean [SD] age, 36.7 [9.0] years) were treated with dequalinium chloride (n = 72) or metronidazole (n = 75). The clinical cure rates at visit 1 were 64 of 69 (92.8%) for dequalinium chloride vs 69 of 74 (93.2%) for metronidazole in the intention-to-treat population, whereas in the per-protocol population, cure rates were 54 of 58 (93.1%) for dequalinium chloride vs 48 of 53 (90.6%) for metronidazole. The treatment differences of -0.5 percentage points (95% CI, -10.8 to 9.8 percentage points; P = .002) in the intention-to-treat population and 2.5 percentage points (95% CI, -9.4 to 14.4 percentage points; P = .001) in the per-protocol population confirmed the noninferiority of dequalinium chloride. The tolerability of dequalinium chloride was rated as very good by 30 of 50 patients (60.0%) but only by 21 of 54 (38.9%) for metronidazole. Three patients in the metronidazole group suspended treatment due to an adverse event. This randomized clinical trial showed that dequalinium chloride was not inferior to metronidazole for the treatment of BV. Dequalinium chloride had a similarly high cure rate but with better tolerability and fewer adverse events. With a similar efficacy to metronidazole and clindamycin, dequalinium chloride warrants consideration as first-line treatment for BV to help reduce antibiotic consumption. EudraCT: 2020-002489-15.

Amniotic Fluid Volume: An Important Deciding Factor for Pregnancy Continuation in Preterm Premature Rupture of Membranes

Abstract Aims and Objectives: To find out various risk factors affecting fetomaternal outcomes in preterm premature rupture of membranes (PPROM). Materials and Methods: A prospective study after approval from the ethical committee was conducted at VMMC and Safdarjung Hospital, New Delhi, Department of Obstetrics and Gynaecology from December 2020 to May 2022 in which 100 pregnant women with preterm premature rupture of membrane between 32 and 36 weeks of gestation were enrolled. Patients were followed with Total leucocyte count (TLC), urine R/M, urine C/S, high vaginal swab C/S, and C-reactive protein along with routine antenatal care investigations. Intravenous antibiotics were given to all patients for 48 h followed by oral antibiotics for 5 days. All patients were on follow-up and managed conservatively and induction of labor was done at 37 weeks or earlier in case of fetal distress and presence of signs and symptoms of chorioamnionitis. Both mother and baby were followed till 7 days after delivery. Results: In the present study, we observed the following risk factors that had adverse effects on fetomaternal outcomes in PPROM patients. The association of oligohydramnios (amniotic fluid index [AFI] &lt;5) with neonatal sepsis (P = 0.025) and neonatal death (P = 0.025) was found to be significant. Vaginal infection was found to be significantly associated with birth asphyxia (P = 0.024), APGAR &lt;7 at 1 min (P = 0.015), neonatal intensive care unit (NICU) admission (P = 0.009), and postpartum hemorrhage (PPH) (P = 0.002). The association of urinary tract infection (UTI) with neonatal sepsis (P = 0.01), birth asphyxia (P = 0.005), APGAR &lt;7 at 1 min (P = 0.001), NICU admission (P = 0.002), neonatal death (P = 0.01), and PPH (P = 0.0004) was found to be significant. We also observed that the duration from membrane rupture to delivery had no adverse effect on fetomaternal outcome, may be as we had given antibiotics to all patients from the time of admission. Conclusions: The conclusion from the present study was that oligohydramnios (AFI &lt;5) is a significant risk factor for adverse neonatal outcomes in PPROM along with vaginal infections and UTIs. Hence, amniotic fluid volume should also be considered as an important deciding factor for pregnancy continuation in PPROM.

Vulvovaginitis due to Enterobius vermicularis in a girl and epidemic enterobiasis in her family

Key Clinical MessageHere we present a case of a 4‐year‐old girl who suffered from vulvovaginitis caused by Enterobius vermicularis. All members of her family were also infected by this helminth. Treatment with mebendazole was administered to all family members and it was found that the entire family had been cured.AbstractVulvovaginitis, an inflammation of the vulvovaginal mucous membranes, is a common reason for pediatric gynecology consultations. One of the causes of this condition is a parasitic worm known as Enterobius vermicularis (E. vermicularis). In girls, adult worms can infiltrate the vagina and release eggs, leading to the development of vulvovaginitis. Furthermore, these worms have the ability to invade the endometrial cavity too. Here we present a case of a 4‐year‐old girl who suffered from vulvovaginitis caused by E. vermicularis. All members of her family were also infected by this parasitic helminth. In the vaginal sample, apart from the eggs, the female adult worm was observed under the microscope. Treatment with mebendazole was administered to all family members, and their progress was followed for a period of 3 weeks, during which it was found that the entire family had been cured. This patient experienced significant improvement in symptoms related to severe anxiety, nervousness, vaginal inflammation, itching, and vulvovaginitis caused by E. vermicularis. To prevent infection by E. vermicularis, it is crucial to disinfect underwear and bed sheets. In kindergartens, the spread of this parasite should not be underestimated, and asymptomatic individuals who have been exposed to infected persons should receive treatment to prevent an epidemic. Maintaining cleanliness and hygiene, especially after using the toilet, is of the most importance, particularly for girls who are more susceptible to E. vermicularis infection. Additionally, it is essential for all family members to be aware of the transmission routes of this parasite.

Risks of Infections With Contraceptive Vaginal Rings Compared to No Hormone Use [ID 2683646

INTRODUCTION: Alterations in the vaginal microbiome by hormones, foreign bodies, intercourse, etc., can affect the body’s susceptibility to infection. The effect of combined contraceptive vaginal rings (CCVRs) on the vaginal microbiome needs more study. We aim to explore the outcomes of CCVRs on vaginal health and infection risk when compared to women without hormone use to better understand the effect of these devices. METHODS: De-identified data were collected from TriNetX. Using ICD-10 and RXNorm codes, populations were selected for women receiving etonogestrel and ethinyl estradiol CCVR without segesterone use, versus sexually active women of reproductive age on no hormonal contraceptives. Cohorts were matched for age at index, race, and ethnicity. Statistical analysis within 1 year of CCVR placement using risk ratios (RRs); P&lt;.05 was considered significant. RESULTS: Cohort sizes were 274,743 each. Combined contraceptive vaginal ring usage showed an increased risk of gonorrhea (RR 1.221; P=.012), HSV-2 (RR 1.229; P&lt;.0005), acute vaginitis (RR 1.314; P&lt;.0005), subacute/chronic vaginitis (RR 1.708; P&lt;.0005), acute vulvitis (RR 1.708; P&lt;.0005), subacute/chronic vulvitis (RR 1.722; P&lt;.0005), pelvic inflammatory disease (RR 1.184; P&lt;.0005), anogenital warts (RR 1.314; P&lt;.0005), and candidiasis (RR 1.402; P&lt;.0005) when compared to women receiving no hormonal contraception. Combined contraceptive vaginal ring showed significant decreased risk of chlamydia (RR 0.786; P&lt;.0005), syphilis (RR 0.493; P&lt;.0005), and HIV (RR 0.434; P&lt;.0005). Trichomoniasis was statistically insignificant. CONCLUSION: Women on etonogestrel and ethinyl estradiol CCVRs have an increased risk of gonorrhea, HSV-2, vaginitis, vulvitis, PID, anogenital warts, and candidiasis, with a decreased risk of chlamydia, syphilis, and HIV when compared to women receiving no hormonal contraception. Further investigation could be useful in developing multipurpose prevention technologies.