Pelvic inflammatory disease is a major or cause of reproductive morbidity worldwide. Its sequelae include tubal infertility, chronic pelvic pain, recurrent PID and ectopic pregnancy. Douching is a common and possibly modifiable potential risk factor for PID, but a handful of previous studies examining this association are retrospective and conflicting. At the same time, compelling data suggest that douching may alter the vaginal microenvironment, thereby predisposing to bacterial vaginosis and perhaps, resultant PID, but this has not been fully tested. We propose to conduct a large, multicenter, prospective cohort study to examine the independent association between douching and PID and to study the effect of douching on vaginal microbiology. We will enroll 1800 women at high risk for acquiring sexually transmitted infections. Half will be women who report douching consistently at least once per month over the past six months; half will be women who report never douching in the past six months. Enrolled women will be evaluated at baseline by interview for behavioral characteristics related to douching and STD risk and by lower genital tract microbiology for N. gonorrhoea, C. trachomatis, bacterial vaginosis, and concentrations of lactobacillus, anaerobes and facultative bacteria. During 3-4.5 years of follow-up, serial interviews will be completed and self-obtained vaginal swabs assessed for lactobacilli and other vaginal bacteria. The primary outcome of PID (symptomatic endometritis), will be compared between the douching and non-douching groups. We will also compare the following: 1) gonococcal or chlamydial cervicitis at baseline, 2) bacterial vaginosis and semi-quantitative lactobacilli concentration at baseline, 3) change during follow-up in the concentration of lactobacilli (hydrogen-peroxide producing and non-producing), as well as anaerobic and facultative bacteria. Given the paucity of information regarding the relationship between douching and reproductive outcomes, the proposed study is imperative in order to direct future public health recommendations.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Project (R01)
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Special Emphasis Panel (ZRG5-BM-2 (14))
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Savarese, Barbara M
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University of Pittsburgh
Public Health & Prev Medicine
Schools of Public Health
United States
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Hutchinson, Katherine B; Kip, Kevin E; Ness, Roberta B (2007) Condom use and its association with bacterial vaginosis and bacterial vaginosis-associated vaginal microflora. Epidemiology 18:702-8
Hutchinson, Katherine B; Kip, Kevin E; Ness, Roberta B et al. (2007) Vaginal douching and development of bacterial vaginosis among women with normal and abnormal vaginal microflora. Sex Transm Dis 34:671-5
Ness, Roberta B; Smith, Kenneth J; Chang, Chung-Chou H et al. (2006) Prediction of pelvic inflammatory disease among young, single, sexually active women. Sex Transm Dis 33:137-42
Ness, Roberta B; Kip, Kevin E; Soper, David E et al. (2006) Variability of bacterial vaginosis over 6- to 12-month intervals. Sex Transm Dis 33:381-5
Ness, Roberta B; Hillier, Sharon L; Kip, Kevin E et al. (2005) Douching, pelvic inflammatory disease, and incident gonococcal and chlamydial genital infection in a cohort of high-risk women. Am J Epidemiol 161:186-95
Ness, Roberta B; Kip, Kevin E; Soper, David E et al. (2005) Bacterial vaginosis (BV) and the risk of incident gonococcal or chlamydial genital infection in a predominantly black population. Sex Transm Dis 32:413-7
Ness, Roberta B; Kip, Kevin E; Hillier, Sharon L et al. (2005) A cluster analysis of bacterial vaginosis-associated microflora and pelvic inflammatory disease. Am J Epidemiol 162:585-90
Haggerty, Catherine L; Ferrell, Robert E; Hubel, Carl A et al. (2005) Association between allelic variants in cytokine genes and preeclampsia. Am J Obstet Gynecol 193:209-15
Ness, Roberta B; Hillier, Sharon L; Kip, Kevin E et al. (2004) Bacterial vaginosis and risk of pelvic inflammatory disease. Obstet Gynecol 104:761-9
Ness, Roberta B; Haggerty, Catherine L; Harger, Gail et al. (2004) Differential distribution of allelic variants in cytokine genes among African Americans and White Americans. Am J Epidemiol 160:1033-8

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