DOCSLIB.ORG

Evaluation of the Effect of Multipoint Intra-Mucosal Vaginal Injection of A

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Evaluation of the Effect of Multipoint Intra-Mucosal Vaginal Injection of A Berreni et al. BMC Women’s Health (2021) 21:322 https://doi.org/10.1186/s12905-021-01435-w RESEARCH ARTICLE Open Access Evaluation of the efect of multipoint intra-mucosal vaginal injection of a specifc cross-linked hyaluronic acid for vulvovaginal atrophy: a prospective bi-centric pilot study Nicolas Berreni1*, Jennifer Salerno2, Thierry Chevalier3, Sandrine Alonso3 and Pierre Mares2 Abstract Background: Vulvo-vaginal atrophy (VVA) is one of the common consequences of estrogen defciency especially after the menopause. Several studies have assessed the efects of Hyaluronic acid (HA) on physical and sexual symp- toms associated with VVA with promising results. However, most of these studies have focused on subjective assess- ment of symptom response to topically administered preparations. Nonetheless, HA is an endogenous molecule and it is logical that its efects are best realized if injected in the superfcial epithelial layers. Desirial® is the frst crosslinked HA that is administered by injection in the vaginal mucosa. The aim of this study was to explore the efect of mul- tipoint vaginal intra-mucosal injections of specifc cross-linked hyaluronic acid (DESIRIAL®, Laboratoires VIVACY) on several clinical and patient reported core outcomes. Methods: A cohort bi-centric pilot study. The chosen outcomes included change in vaginal mucosa thickness, bio- logical markers for collagen formation, vaginal fora, vaginal pH, vaginal health index, vulvo-vaginal atrophy symptoms and sexual function 8 weeks post Desirial® injection. Patients’ satisfaction was also assessed using the patient global impression of improvement (PGI-I) scale. Results: A total of 20 participants were recruited between 19/06/2017 and 05/07/2018. At the end of the study, there was no diference in the median total thickness of the vaginal mucosa or in procollagen I, III or Ki67 fuores- cence. However, there was a statistically signifcant increase in COL1A1 and COL3A1 gene expression (p 0.0002 and p 0.0010 respectively). There was also a signifcant reduction in reported dyspareunia, vaginal dryness,= vulvar pruritus,= vaginal chafng and signifcant improvement in all female sexual function index dimensions. Based on PGI-I, 19 patients (95%) reported varying degrees of improvement where, 4 (20%) felt slightly better; 7 (35%) better and 8 (40%) much better. Conclusions: Multi-point vaginal intra-mucosal injections, of Desirial® (a crosslinked HA) was signifcantly associated with the expression of CoL1A1 and CoL3A1 suggesting stimulation of collagen formation. Furthermore, there was a signifcant reduction in VVA symptomatology and a signifcant improvement in patient satisfaction and sexual func- tion scores. However, there was no demonstrable change in the total vaginal mucosal thickness. Study registration ID-RCB: 2016-A00124-47, Protocol code number: LOCAL/2016/PM-001. *Correspondence: [email protected] 1 Gynecology Private Practice, Perpignan, France Full list of author information is available at the end of the article © The Author(s) 2021. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http:// creat iveco mmons. org/ licen ses/ by/4. 0/. The Creative Commons Public Domain Dedication waiver (http:// creat iveco mmons. org/ publi cdoma in/ zero/1. 0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Berreni et al. BMC Women’s Health (2021) 21:322 Page 2 of 9 Keywords: Collagen, Desirial, Dryness, Dyspareunia, FSFI, Hyaluronic acid, Menopause, PGI-I, Vulvo-vaginal atrophy Background mucosa. It is a polysaccharide from the glycosamino-gly- Vulvo-vaginal atrophy (VVA) is one of the common can family that plays a major role in maintaining water consequences of estrogen defciency especially after the balance and the regulation of infammation, immune menopause [1–4]. Several clinical syndromes are asso- response, scarring and angiogenesis [20, 21]. Synthetic ciated with VVA, including, dryness, irritation, pruri- HA preparations are available in the form of local gels tus, dyspareunia, and recurrent urinary tract infections, and have a “medical device” status. Several studies which can have a signifcant negative impact on the have assessed the efects of HA on physical and sexual woman’s quality of life [5]. However, the onset of these symptoms associated with VVA with promising results can be subtle and gradual and start to become notice- [22–25]. However, most of these studies have focused able after other menopausal symptoms have subsided. It on subjective assessment of symptom response to topi- is reported that up to 55%, 41% and 15% of postmeno- cally administered preparations. Nonetheless, HA is an pausal women sufer from vaginal dryness, dyspareunia endogenous molecule and it is logical that its efects are and recurrent urinary tract infections respectively [6–9]. best realized if injected in the superfcial epithelial layers. Nevertheless, it is suggested that the actual prevalence of Desirial® is the frst crosslinked HA that is administered these problems is higher but the majority of women do by injection in the vaginal mucosa. not seek medical help for their symptoms [6]. Te mainstay of VVA management is symptomatic and Methods includes lifestyle modifcations, non-hormonal (e.g. vagi- Te aim of this prospective bi-centric pilot study was to nal lubricants or moisturizers and laser treatments) and explore the efect of multipoint vaginal intra-mucosal hormonal treatment options. Vaginal lubricants are, pri- injections of specifc cross-linked hyaluronic acid marily, used to relieve vaginal dryness during intercourse, (DESIRIAL®, Laboratoires VIVACY) on several clinical and hence, do not provide an efective solution for the and patient reported core outcomes and assess the fea- chronic and complex nature of VVA symptomatology. In sibility of evaluating these outcomes. Te comprehensive contrast, vaginal moisturizers are “bio-adhesive” prod- set of chosen outcomes for this study included the change ucts that facilitate water retention have been reported in vaginal mucosa thickness, biological markers for tissue to improve vaginal irritation and dyspareunia when used regeneration, vaginal fora, vaginal pH and vaginal health regularly [10]. Nonetheless, this was not associated with index 8 weeks post Desirial® injection. We measured improvement in the overall vaginal epithelium matura- several patient-reported outcomes including change in tion index [11]. In recent years, there have been several sexual function and reported rates of VVA related symp- claims for the use of radiofrequency and laser for the toms over the same time point. Patients’ satisfaction was treatment of vaginal menopausal symptoms [12–15]. assessed using the patient global impression of improve- Nevertheless, the FDA has issued an alert to patients ment (PGI-I) scale at the end of the study. stressing that the use of such procedures may be associ- ated with serious adverse events and that the safety and Participants efectiveness of energy-based devices for the treatment Te study population comprised of postmenopausal of these conditions has not been established [16]. Evi- women (between 2 and 10 after the menopause) referred dence from meta-analyses of several randomized studies to the menopause clinic with symptoms of vaginal dis- support the efectiveness of hormonal treatments, both comfort and/or dyspareunia secondary to vaginal dry- local and systematic, in relieving VVA associated symp- ness. Women had to be ≥ 18 years and < 70 years of age toms [17–19]. However, a limited number of studies have with a BMI of < 35. Participants were recruited from one assessed the sustained efect of such treatments beyond of 2 participating units (Centre Hospitalier Régional 6 months of therapy. Moreover, their contraindications Universitaire, Nîmes (CHRU), France and Karis Medical and personal choice are limiting factors to the wide- Center (KMC), Perpignan, France). Women were consid- spread and long-term use of these treatment options. ered eligible if they were afliated to or were benefciar- Terefore, at present, there is still a need for a safe and ies of a health insurance plan and they knew they would efective solution for the management of VVA related be available for the 8-week planned follow-up period. symptoms. Women participating in other studies at the time were Hyaluronic acid (HA) is an extracellular matrix key not eligible for recruitment. Te presence of ≥ stage 2 molecule present in several tissues including the vaginal apical pelvic organ prolapse, stress urinary incontinence, Berreni et al. BMC Women’s Health (2021) 21:322 Page 3 of 9 vaginismus, vulvovaginal or urinary tract infection, Hem- packaged in pre-flled syringes (2 × 1 ml). It is a class III orrhagic or neoplasic genital
Load more

Recommended publications
  • Vaginitis and Abnormal Vaginal Bleeding
    UCSF Family Medicine Board Review 2013 Vaginitis and Abnormal • There are no relevant financial relationships with any commercial Vaginal Bleeding interests to disclose Michael Policar, MD, MPH Professor of Ob, Gyn, and Repro Sciences UCSF School of Medicine [email protected] Vulvovaginal Symptoms: CDC 2010: Trichomoniasis Differential Diagnosis Screening and Testing Category Condition • Screening indications – Infections Vaginal trichomoniasis (VT) HIV positive women: annually – Bacterial vaginosis (BV) Consider if “at risk”: new/multiple sex partners, history of STI, inconsistent condom use, sex work, IDU Vulvovaginal candidiasis (VVC) • Newer assays Skin Conditions Fungal vulvitis (candida, tinea) – Rapid antigen test: sensitivity, specificity vs. wet mount Contact dermatitis (irritant, allergic) – Aptima TMA T. vaginalis Analyte Specific Reagent (ASR) Vulvar dermatoses (LS, LP, LSC) • Other testing situations – Vulvar intraepithelial neoplasia (VIN) Suspect trich but NaCl slide neg culture or newer assays – Psychogenic Physiologic, psychogenic Pap with trich confirm if low risk • Consider retesting 3 months after treatment Trichomoniasis: Laboratory Tests CDC 2010: Vaginal Trichomoniasis Treatment Test Sensitivity Specificity Cost Comment Aptima TMA +4 (98%) +3 (98%) $$$ NAAT (like GC/Ct) • Recommended regimen Culture +3 (83%) +4 (100%) $$$ Not in most labs – Metronidazole 2 grams PO single dose Point of care – Tinidazole 2 grams PO single dose •Affirm VP III +3 +4 $$$ DNA probe • Alternative regimen (preferred for HIV infected
    [Show full text]
  • Original Article
    ORIGINAL ARTICLE ASSOCIATION OF BACTERIAL VAGINOSIS WITH PRETERM LABOUR Shilpa M.N1, A.P. Chandrashekar2, G.S. Vijay Kumar3, Rashmi P. Mahale4 HOW TO CITE THIS ARTICLE: Shilpa M.N, A.P Chandrashekar, G.S. Vijay Kumar, Rashmi P. Mahale. “Association of bacterial vaginosis with preterm labour”. Journal of Evolution of Medical and Dental Sciences 2013; Vol2, Issue 32, August 12; Page: 6104-6110. ABSTRACT: OBJECTIVES: To study the prevalence of bacterial vaginosis (BV) in preterm labour and to investigate its association as one of the causative factors of preterm labour. MATERIALS AND METHODS: Fifty women who presented with preterm labour (study group) and fifty women in labour at term (control group) admitted to a teaching hospital from November 2009 to May 2011 were examined for bacterial vaginosis using Nugent score. All the statistical methods were carried out through SPSS for windows (version 16.0), STUDY DESIGN: A comparative study. RESULTS: The prevalence of bacterial vaginosis among preterm labour group was 22% and its prevalence among full term group was 4%. There was statistically significant association of BV with preterm labor when compared to term labor (p=.007). Bacterial Vaginosis was strongly associated with very preterm delivery (<34 weeks) (p=.050). Bacterial vaginosis was significantly associated with lesser gestational age at delivery and low birth weight. CONCLUSION: Bacterial vaginosis is significantly associated with preterm labour and is one of the probable causative factors of preterm labour. KEYWORDS: Bacterial vaginosis, Nugent score, Preterm labor. INTRODUCTION: Preterm labour is defined as onset of labour prior to completion of 37 weeks gestation after period of viability.1,2 Though only 7-10% of all deliveries are preterm, prematurity alone accounts for more than 80% of perinatal morbidity and mortality in India.1,2,3,4 The etiology for preterm labour is multifactorial and in many of the cases is obscure.
    [Show full text]
  • Evaluation of Different Diagnostic Methods of Bacterial Vaginosis
    IOSR Journal of Dental and Medical Sciences (IOSR-JDMS) e-ISSN: 2279-0853, p-ISSN: 2279-0861. Volume 13, Issue 1, Ver. VIII (Feb. 2014), PP 15-23 www.iosrjournals.org Evaluation of different diagnostic methods of bacterial vaginosis Gamal F. M. Gad¹, Ahmed R. El-Adawy², Mohammed S. Mohammed3, Abobakr F. Ahmed1, Heba A. Mohamed¹ ¹ Microbiology department, Faculty of Pharmacy, Minia University 2 Gynecology and Obstetrics department, Faculty of Medicine, Minia University 3 Microbiology department, Faculty of Medicine, Minia University Abstract: Bacterial vaginosis (BV) is an ecological disorder of the vaginal microbiota that affects millions of women annually, and is associated with numerous adverse health outcomes including pre-term birth and the acquisition of sexually transmitted infections. This study aimed to determine the incidence rate of bacterial vaginosis among women and examine the effect of some risk factors and demographic features on BV incidence. Also aimed to compare between the different methods of BV diagnosis. The results revealed that from the 100 patients, 33% were diagnosed as bacterial vaginosis, 23% were having candidiasis, 8% aerobic vaginitis, 3% trichomoniasis and 33% were normal. The highest number of BV positive cases was in the age group of (26-35)Yrs, 94% of the 33 BV positive cases were using vaginal douches and 94% were married. BV positive cases using IUD were equal to BV positive cases using hormonal contraceptives including injection and tablets (12/33, 36.4%). BV was diagnosed in 33%, 38%, 36%, 30% and 34% of patients using Gram stain, culture, Amsel criteria, BV Blue test® and qPCR respectively.
    [Show full text]
  • Diagnosing Bacterial Vaginosis with a Novel, Clinically-Actionable Molecular Diagnostic Tool
    ISSN: 2581-7566 Volume 1: 2 J Appl Microb Res 2018 Journal of Applied Microbiological Research Diagnosing Bacterial Vaginosis with a Novel, Clinically-Actionable Molecular Diagnostic Tool Joseph P Jarvis1 Doug Rains2 1Coriell Life Sciences, Pennsylvania, USA Steven J Kradel1 2Quantigen Genomics, Indiana, USA James Elliott2 3ThermoFisher Scientific, USA Evan E Diamond3 4Primex Clinical Laboratories, California, USA Erik Avaniss-Aghajani4 5Maternity & Infertility Institute, California, USA Farid Yasharpour5 Jeffrey A Shaman1* Abstract Article Information Bacterial vaginosis is a common condition among women of Article Type: Research reproductive age and is associated with potentially serious side-effects, Article Number: JAMBR109 including an increased risk of preterm birth. Recent advancements in Received Date: 15 June, 2018 microbiome sequencing technologies have produced novel insights Accepted Date: 11 July, 2018 into the complicated mechanisms underlying bacterial vaginosis and Published Date: 18 July, 2018 have given rise to new methods of diagnosis. Here we report on the validation of a quantitative, molecular diagnostic algorithm based on *Corresponding author: Dr. Jeffrey A Shaman, Coriell the relative abundances of ten potentially pathogenic bacteria and four Life Sciences, Philadelphia, Pennsylvania, USA. Tel: + 609 357 0578; Email: jshaman(at)coriell.com as symptomatic (n=149) or asymptomatic (n=23). We observe a clear #These Authors are Joint First Authors on this Work. commensal Lactobacillus species in research subjects (n=172) classified and reinforcing pattern among patients diagnosed by the algorithm that Citation: Jarvis JP, Rains D, Kradel SJ, Elliott J, Diamond is consistent with the current understanding of biological dynamics EE, Avaniss-Aghajani E, Yasharpour F, Shaman JA (2018) and dysregulation of the vaginal microbiome during infection.
    [Show full text]
  • Bacterial Vaginosis in Pregnancy and Risk of Spontaneous Preterm
    Bacterial vaginosis in pregnancy and risk of spontaneous preterm delivery Approved at the obstetrical guideline-meeting January 2015 Danish Society of Obstetrics and Gynecology (DSOG) Update February 2019 The Lancet has now published reference 31b, by Subtil et al. (2018). The 2015 version of the DSOG guideline included this reference as a congress presentation (ref. 31a), i.e. the risk of bias was high. However, the DSOG working group finds that this publication supports the DSOG recommenda- tions from 2015 (see “Update February 2019” for details). Apart from the “Update February 2019” paper, we did not make any other changes to the original guideline from 2015 . Members of the working group • DSOG: Niels Uldbjerg (chairman, [email protected], +4520679420), Anne Ersbøll, Jens Svare, Kirstine Sneider, Rikke Bek Helmig, Thor Haahr, Mona Aarenstrup Karlsen, Lene Hee Christensen. • Midwife: Louise Weile (MHSc) • Clinical Pharmacology: Agnes Ziobrowska Bech, MD (Department of Clinical Pharmacology, Aarhus University Hospital) • Clinical Microbiology: Claus Østergaard MD, consultant (Department of Clinical Microbiology, Vejle, Denmark) • External reviewers: Bo Jacobsson MD, professor & Ronald Lamont MD, professor. • Advisor concerning diagnostic criteria: Jørgen Skov Jensen (Statens Seruminstitut) Objective The objective of this guideline is to evaluate bacterial vaginosis in pregnancy concerning • Different treatments for prevention of preterm delivery. • Screening of pregnant women with low as well as high risk of sPTD. • Stratification into gestational ages below and above 16 weeks. • Diagnostic methods. Key words Bacterial vaginosis, vaginal pH, pH-glove, vaginal discharge, Nugent score, Amsel score, Gardnerella vaginalis, Mobiluncus species, preterm delivery, preterm birth, GRADE, clindamycin, metronidazole, screening, treatment, probiotics, antibiotics, dysbiosis, abnormal vaginal flora.
    [Show full text]
  • Vaginal Probiotics for Reproductive Health and Related Dysbiosis: Systematic Review and Meta-Analysis
    Journal of Clinical Medicine Review Vaginal Probiotics for Reproductive Health and Related Dysbiosis: Systematic Review and Meta-Analysis Ana López-Moreno 1,2,* and Margarita Aguilera 1,2,3,* 1 Department of Microbiology, Faculty of Pharmacy, Campus of Cartuja, University of Granada, 18071 Granada, Spain 2 Instituto de Nutrición y Tecnología de los Alimentos, INYTA-Granada, 18100 Granada, Spain 3 Instituto de Investigación Biosanitaria, Ibs-Granada, 18012 Granada, Spain * Correspondence: [email protected] (A.L.-M.); [email protected] (M.A.); Tel.: +34-9-5824-5129 (M.A.); Fax: +34-958-246235 (M.A.) Abstract: The use of probiotics in reproductive-related dysbiosis is an area of continuous progress due to the growing interest from clinicians and patients suffering from recurrent reproductive microbiota disorders. An imbalance in the natural colonization sites related to reproductive health—vaginal, cervicovaginal, endometrial, and pregnancy-related altered microbiota—could play a decisive role in reproductive outcomes. Oral and vaginal administrations are in continuous discussion regarding the clinical effects pursued, but the oral route is used and studied more often despite the need for further transference to the colonization site. The aim of the present review was to retrieve the standard- ized protocols of vaginal probiotics commonly used for investigating their microbiota modulation capacities. Most of the studies selected focused on treating bacterial vaginosis (BV) as the most common dysbiosis; a few studies focused on vulvovaginal candidiasis (VVC) and on pretreatment during in vitro fertilization (IVF). Vaginal probiotic doses administered were similar to oral probiotics Citation: López-Moreno, A.; 7 10 Aguilera, M. Vaginal Probiotics for protocols, ranging from ≥10 CFU/day to 2.5 × 10 CFU/day, but were highly variable regarding Reproductive Health and Related the treatment duration timing.
    [Show full text]
  • The Prevalence of Bacterial Vaginosis and Candidiasis in Postmenopausal Women
    THE PREVALENCE OF BACTERIAL VAGINOSIS AND CANDIDIASIS IN POSTMENOPAUSAL WOMEN Ivanka Hadji Petrusheva Meloska1, Konstantin Icev1, Branko Jaglikovski1, Anica Hadji-Petrusheva Jankijevikj2, Biljana Curcic-Trajkovska2. 1Avicena Laboratory, Skopje, Macedonia.; 2Clinical Hospital Acibadem Sistina, Skopje, Macedonia Graph 3. Nugent‘s score among different age groups INTRODUCTION MATERIAL AND METHODS RESULTS The prevalence of BV (assessed as a Bacterial vaginosis (BV) is the most A total of 750 vaginal and cervical 500 NS of >or=7) in postmenopausal common cause of vaginal symptoms swabs, collected from 450 women was low (5,6% - 42 cases) and 400 characterized by a change of vaginal postmenopausal women age 40-69 350 NS1-4 GV was isolated in most of those 300 flora from years, were examined. BV was NS 4-6 cases. A high percentage (51.0% - 383) 250 predominant Lactobacillus to diagnosed microscopically by 200 NS>7 of postmenopausal women (NS of 1-4) 150 replacement with anaerobes such as Nugent's score (NS), the presence of had decreased number of lactobacilli 100 Gardnerella vaginalis (GV). Bacterial leukocytes in the slides was noted and no BV -associated 50 0 vaginosis occurs when the normal too. Detection of aerobic and microorganisms. In this category there age 40-49 age 50-59 age 60-69 lactobacilli of the vagina are replaced anaerobic bacteria and fungi was were 35 cases with leukocytes in the Graph 4. Microbiology findings by mostly anaerobic bacteria. performed by conventional vaginal smear, where cultures 60 p<0.05 Diagnosis is commonly made using microbiological methods. revealed presence of enterobacteriaceae and gram positive 50 the Nugent criteria, which include 40 cocci.
    [Show full text]
  • Universidade Estadual De Campinas Faculdade De Ciências Médicas
    UNIVERSIDADE ESTADUAL DE CAMPINAS FACULDADE DE CIÊNCIAS MÉDICAS EDILSON BENEDITO DE CASTRO EFICÁCIA E SEGURANÇA DA COLPOPEXIA SACROESPINHAL VAGINAL E DA SACROCOLPOPEXIA ABDOMINAL PARA TRATAMENTO DO PROLAPSO UTERINO: UM ESTUDO RANDOMIZADO EFICACY AND SAFETY OF VAGINAL SACROSPINOUS COLPOPEXY AND ABDOMINAL SACROCOLPOPEXY FOR UTERINE PROLAPSE TREATMENT - A RANDOMIZED STUDY CAMPINAS 2018 EDILSON BENEDITO DE CASTRO EFICÁCIA E SEGURANÇA DA COLPOPEXIA SACROESPINHAL VAGINAL E DA SACROCOLPOPEXIA ABDOMINAL PARA TRATAMENTO DO PROLAPSO UTERINO: UM ESTUDO RANDOMIZADO EFICACY AND SAFETY OF VAGINAL SACROSPINOUS COLPOPEXY AND ABDOMINAL SACROCOLPOPEXY FOR UTERINE PROLAPSE TREATMENT - A RANDOMIZED STUDY Tese apresentada ao Programa de Pós-Graduação em Tocoginecologia da Faculdade de Ciências Médicas da Universidade Estadual de Campinas como parte dos requisitos exigidos para a obtenção do título de Doutor em Ciências da Saúde, área de concentração Fisiopatologia Ginecológica. Thesis submitted to the Postgraduate Program in Obstetrics and Gynecology, School of Medical Sciences, State University of Campinas (UNICAMP), for the purpose of obtaining the title of Phd in Health Sciences, area of concentration in Gynecological pathophysiology. ORIENTADORA: PROFª. DRª. CÁSSIA RAQUEL TEATIN JULIATO ESTE EXEMPLAR CORRESPONDE À VERSÃO FINAL DA TESE DEFENDIDA PELO ALUNO EDILSON BENEDITO DE CASTRO E ORIENTADA PELA PROFª. DRª. CÁSSIA RAQUEL TEATIN JULIATO. CAMPINAS 2018 BANCA EXAMINADORA DA DEFESA DE DOUTORADO EDILSON BENEDITO DE CASTRO ORIENTADORA: PROFª. DRª CÁSSIA RAQUEL TEATIN JULIATO MEMBROS: 1. PROF. DRª. CÁSSIA RAQUEL TEATIN JULIATO 2. PROF. DR. CASSIO LUIS ZANETTINI RICCETTO 3. PROF. DRª. LUCIA HELENA SIMÕES DA COSTA PAIVA 4. PROF. DR. JORGE MILHEN HADDAD 5. PROF. DR. RODRIGO DE AQUINO CASTRO Programa de Pós-Graduação em Tocoginecologia da Faculdade de Ciências Médicas da Universidade Estadual de Campinas A ata de defesa com as respectivas assinaturas dos membros da banca examinadora encontra-se no processo de vida acadêmica do aluno.
    [Show full text]
  • The Relation of the Vaginal Microbiota to Early Pregnancy Development
    Journal of Gynecology Obstetrics and Human Reproduction 48 (2019) 223–229 Available online at ScienceDirect www.sciencedirect.com Review The relation of the vaginal microbiota to early pregnancy development during in vitro fertilization treatment—A meta-analysis a,b, ,1 a,c,1 a a,b,c M. Singer * , M. Borg , S. Ouburg , S.A. Morré a Laboratory of Immunogenetics, Department of Medical Microbiology and Infection Control, Amsterdam UMC: Vrije Universiteit, Amsterdam, the Netherlands b Tubascan, spin-off at the Department of Medical Microbiology and Infection Control, Amsterdam UMC: Vrije Universiteit, Amsterdam, the Netherlands c Institute of Public Health Genomics, Department of Genetics and Cell Biology, School for Oncology and Developmental Biology (GROW), Faculty of Health, Medicine & Life Sciences, University of Maastricht, Maastricht, the Netherlands A R T I C L E I N F O A B S T R A C T Article history: An abnormal vaginal microbiota composition has been shown to lead to pre-term births, miscarriage, and Received 28 December 2018 problems with conceiving. Studies have suggested that dysbiosis reduces successful early pregnancy Accepted 22 January 2019 development during IVF. However, conflicting reports exist. This meta-analysis aims to answer the Available online 24 January 2019 following question: what is the aggregated effect found by studies investigating the influence of the vaginal microbiota composition on early pregnancy rates after IVF treatment? Keywords: A systematic review was performed using the Medline and EMBASE databases, using search terms for Vaginal healthy vaginal microbiota, abnormal vaginal microbiota, fertility and pregnancy. The search resulted in Microbiota six included articles.
    [Show full text]
  • Study Protocol, Documentation, Data, and All Other Information Generated Will Be Held in Strict Confidence
    Phase II-b Randomized Double-Blind Placebo-Controlled Trial of Lactobacillus crispatus CTV-05 (LACTIN-V) to Prevent the Recurrence of Bacterial Vaginosis A Study of the Sexually Transmitted Infection Clinical Trials Group (STI CTG) DMID Protocol Number: 14-0029 DMID Funding Mechanism: Contract Number: HHSN272201 3000141 Task Order Number: HHSN27200003 Pharmaceutical Support Provided by: Osel, Inc. IND Sponsor: Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases National Institutes of Health 5601 Fishers Lane Bethesda, MD 20892 Principal Investigator: Craig R. Cohen, MD, MPH DMID Clinical Project Manager: Jonathan Glock, MPH DMID Medical Monitor: Soju Chang, MD DMID Medical Officer: Jill Long, MD, MPH Version 3.0 19 February 2016 DMID14-0029 Version 3.0 February 19, 2016 ____________________________________________________________________________________________ STATEMENT OF COMPLIANCE The study will be carried out in accordance with Good Clinical Practice (GCP) as required by the following • United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 46; 21 CFR Part 50, 21 CFR Part 56, and 21 CFR Part 312) • ICH E6; 62 Federal Register 25691 (1997) • NIH Clinical Terms of Award All key personnel (all individuals responsible for the design and conduct of this study) have completed Human Subjects Protection Training. ____________________________________________________________________________________________ i DMID14-0029 Version 3.0 February 19, 2016 ____________________________________________________________________________________________ SIGNATURE PAGE The signature below constitutes the approval of this protocol and the attachments, and provides the necessary assurances that this trial will be conducted according to all stipulations of the protocol, including all statements regarding confidentiality, and according to local legal and regulatory requirements and applicable US federal regulations and ICH guidelines.
    [Show full text]
  • Aerobic Vaginitis: Abnormal Vaginal Flora That Is Distinct from Bacterial Vaginosis
    Aerobic Vaginitis: Abnormal Vaginal Flora That Is Distinct From Bacterial Vaginosis. Aerobic vaginitis (AV) is a state of abnormal vaginal flora that is distinct from the more common bacterial vaginosis (BV) (Table 1). AV is caused by a displacement to respond to therapy at one week and will experience of the healthy vaginal Lactobacillus species with aerobic persistent symptoms. (4, 5) It is believed that a subset of pathogens such as Escherichia coli, Group B Streptococcus these patients may have been misdiagnosed and actually (GBS), Staphylococcus aureus, and Enterococcus faecalis suffer from AV, which requires an antibiotic therapy with that trigger a localized vaginal inflammatory immune intrinsic activity against specific aerobic bacteria. AV has response. Clinical signs and symptoms include vaginal been implicated in complications of pregnancy such as inflammation, an itching or burning sensation, dyspareunia, ascending chorioamnionitis, premature rupture of the yellowish discharge, and an increase in vaginal pH > 4.5, membranes, and preterm delivery. and inflammation with leukocyte infiltration. (1) Severe, persistent, or chronic forms of AV can also be referred to as Epidemiology desquamative inflammatory vaginitis (DIV). (2, 3) In a study of 631 patients attending routine prenatal care BV is a common vaginal disorder associated with the from a vaginitis clinic, 7.9% had moderate to severe AV overgrowth of anaerobic bacteria, a distinct vaginal signs and symptoms and 6% had ‘full-blown’ BV. (1) malodorous discharge, but is not usually associated with a strong vaginal inflammatory immune response. Like AV, In a study of 3,000 women, 4.3% were found to have severe BV also includes an elevation of the vaginal pH > 4.5 and AV, also called DIV.
    [Show full text]
  • Non-Candidal Vaginitis: a Comprehensive Approach to Diagnosis & Management
    1 Non-Candidal Vaginitis: A Comprehensive Approach to Diagnosis & Management Chemen M. Neal, MD1 Ms. Lauren H. Kus, BA1 Linda O. Eckert, MD2 Jeffrey F. Peipert, MD, PhD1 Indiana University School of Medicine, Indianapolis, IN1 The University of Washington, Seattle, WA2 The authors report no conflict of interest. Corresponding Author: Chemen M. Neal, MD Department of Obstetrics & Gynecology Indiana University School of Medicine 550 N University Blvd., UH2440 Indianapolis, IN 46208 Email: [email protected] Phone: (317) 944-8609 Fax: (317) 944-7417-6722 Abstract Word Count: 232 Manuscript Word Count: 3,848 ____________________________________________________ This is the author's manuscript of the article published in final edited form as: Neal, C. M., Kus, L. H., Eckert, L. O., & Peipert, J. F. (2019). Non-Candidal Vaginitis: A Comprehensive Approach to Diagnosis & Management. American Journal of Obstetrics and Gynecology. https://doi.org/10.1016/j.ajog.2019.09.001 2 CONDENSATION This article presents a comprehensive description of the causes, evaluation, and treatment of non-candidal vaginitis. Short title: Non-Candidal Vaginitis Review 3 ABSTRACT Vaginitis is one of the most common causes of patient visits to gynecologists, primary care providers, and urgent care centers. However, many women leave without a clear diagnosis or experience recurrent symptoms despite treatment. The three most common etiologies of vaginitis are trichomonas, bacterial vaginosis, and vulvovaginal candidiasis, which account for an estimated 70% of cases. The remaining 30% may be related to other causes of vaginitis, including atrophic vaginitis, desquamative inflammatory vaginitis, and vaginal erosive disease. The purpose of this review is to describe the non-candidal causes of acute and recurrent vaginitis, with the goal of improving the likelihood of accurate diagnosis as well as efficient and effective therapy.
    [Show full text]