Between May 1999, and June 2001, women 13 to 36 years of age were recruited from five sites located in the eastern, southern, and western regions of the US into the GYN Infections Follow-through (GIFT) Study, a cohort investigation of the health consequences of douching. Human subjects approval was obtained at each participating institution and all women signed informed consent. Women enrolled from public and private gynecology clinics, student health services, and health departments, were eligible for the GIFT study if they were not specifically seeking care for an STI, yet were at elevated risk based on a previous risk stratification paradigm for chlamydial cervicitis, as described below.

To be eligible, a woman had to have a score of three points or more on an algorithm wherein points were derived as follows: age 24 or less = 1; black race = 2; never pregnant = 1; two or more sexual partners = 1; douched at least once per month = 2; any sexually transmitted infection, including N. gonorrhoeae, C. trachomatis, and T. vaginalis = 2. Of 2740 women screened for study entry, 853 (31.1%) did not meet these inclusion criteria. An additional 259 (9.5%) women were excluded on the basis of a priori criteria including: currently pregnant by beta HCG testing, currently married, never having had sexual intercourse, having had a prior hysterectomy, salpingectomy, or tubal ligation, or being on antibiotics at baseline (because of their lower sexually transmitted disease risk); cr having pelvic tenderness on examination at baseline. Among the 1628 women who were eligible for the study, 1200 (73.7%) agreed to study participation, 1135 of whom identified themselves as black or non-Hispanic white and are the focus of these analyses. viagra soft

Identification of Bacterial Vaginosis

At baseline, study staff taught each subject how to self-collect vaginal specimens using a Q-tip®-like cotton swab. Vaginal swabs were smeared onto slides by study staff at the bedside and these slides were air dried and later Gram-stained at a centralized, expert microbiology laboratory under the direction of one of us (SLH). As per Nugent et al., a score of 0-10 was assigned in light of the relative proportions of large Gram-positive rods (lactobacilli), small Gram-negative or Gram-variable rods (Bacteroides or Gardnerella), and curved Gram-variable rods (Mobiluncus). A score of 0-3 was interpreted as consistent with normal vaginal flora; a score of 4-6, corresponding to disturbed flora, was designated as intermediate; and a score of 7-10 was considered to be bacterial vaginosis.

Microbiologic Methods for Evaluation of the Vaginal Flora

Two swabs, placed in an anaerobic transport vial, were also shipped to the microbiology laboratory for characterization of the bacteria including the following: Lactobacillus species, anaerobic Gram negative rods, Gardnerella vaginalis, and Mycoplasma hominis. One vaginal swab was used to inoculate a human blood bilayer Tween agar for detection of G vaginalis. A second swab was used to inoculate a Rogosa agar for recovery of lactobacilli, a Brucella agar for recovery of anaerobic bacteria and broth media for recovery of M. hominis.
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Lactobacilli were identified to the genus level on the basis of Gram-stain morphology and production of lactic acid. All lactobacilli were tested for production of H₂0₂ using a qualitative assay on a tetramethylbenzidine agar plate. After two days of incubation at 37° С in the anaerobic glove box, the agar plates were exposed to ambient air. Hydrogen peroxide formed and horse radish peroxidase in the agar oxidized the tetramethylbenzidine, which caused the Lactobacillus colonies to turn blue.

Potential Risk Factors

In a standardized 20-minute interview conducted by trained research staff at each center, women were asked about demographic factors including age, race, highest level of educational attainment, income, marital status, and gravidity. They reported relevant lifestyle behaviors such as tobacco smoking, number of sexual partners in the past two months, acquisition of a new partner in the past two months, various types of contraceptive use, and sex with menses. Furthermore, they were asked to recall past episodes of sexually transmitted infections including PID, gonococcal cervicitis, chlamydial cervicitis, bacterial vaginosis, and trichomoniasis. Women also were asked about their douching behavior including whether they had practiced any douching in the past two months, their frequency of douching in the past two months, and the timing of the most recent episode of douching. For purposes of analyses, the douching frequency data were categorized into none, <l/mo, >l/mo, and the douching recency data were categorized into seven or fewer days ago, 8-21 days ago, and >22 days ago.
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Statistical Analysis

The differences between the two groups were analyzed with the chi-square test for categorical comparisons. First, among black women and among white women separately, we calculated the proportion within a priori risk factor categories. Next, within each racial group, we evaluated the relationship between risk factors and BV. Intermediate vaginal flora was combined with BV into a single outcome because the two categories related similarly to various risk factors including douching. We subsequently compared BV with the combination of intermediate flora plus normal flora and found little difference in the main results. Odds ratios, with corresponding 95% confidence intervals (CI) were calculated as the primary measure of effect size for the relationship between risk factors and BV/intermediate vaginal flora within racial groups. We compared odds ratios across racial groups using Woolf’s test for heterogeneity.

In order to delineate the independent relationships between risk factors and the dependent variable, BV/intermediate vaginal flora, we conducted separate logistic regression models within black women and white women. Independent variables that had been identified on the basis of biologic plausibility and preliminary univariate analyses as possible confounders were included in these models with the exception of highly collinear variables. We also substituted education for income, as the later was missing for almost 10% of the cohort and the switch of education for income within models had little impact on the significance of other comparisons. Simplification of the models, with elimination of consistently insignificant covariates (p<0.10) yielded a final model including: clinical site; age (continuous); education (high school graduate or lesser attainment versus post-high school); history of trichomoniasis (yes/no); gravidity (ever/never); current smoking (yes/no); sex with menses (yes/no); oral contraceptive or other hormonal contraceptive use within the past two months (yes/no); and douching (never/<l/month/>l/month). Finally, we combined all (black and white) women into one model and, in addition to all other terms, included a dichotomous term for race. This allowed us to determine whether race remained independently associated with BV/intermediate flora after adjustment for known risk factors.
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In additional analyses, we repeated both the univariate and multivariate analytic strategies for the outcome variables H₂0₂+ lactobacillus (versus either no lactobacillus or H₂0₂-), G vaginalis (yes/no), M. hominis (yes/no), anaerobic Gram negative rods pigmented (yes/no), anaerobic Gram negative rods non-pigmented (yes/no), Mobiluncus morphotypes (yes/no), and gonococcal or chlamydial cervicitis (yes/no).