An observational study in HIV and Pregnancy, sponsored by Boston Medical Center. Completed at 1 site in United States. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-09.
Sponsored by Boston Medical Center · Observational
The innate immunity of the vaginal tract provides first-line defense from abnormal microorganisms or overgrowth of common organisms, such as Candida species or Gardnerella vaginalis. It is unclear from the current available literature whether the rate of vaginal infection increases or decreases in frequency during pregnancy when compared to the non-pregnant state, but this may be predicted by shifts in vaginal innate immunity. Vaginal infections are important players in HIV disease, potentially increasing the risk of viral transmission. In addition, these infections may activate inflammatory markers in the reproductive tract and increase the risk of premature delivery or other negative pregnancy outcomes. The vaginal innate immune system has not been well characterized in pregnant women, or in women with HIV infection. The study of how this system changes in pregnancy and HIV infection will provide essential knowledge for further study of vaginal mucosal protection.
The investigators study is an observational study designed to compare levels of vaginal innate immunity markers in women based on a) pregnancy status and b) HIV infection status. Comparisons will be made between pregnant and non- pregnant women and between HIV positive and HIV negative women. The investigators hypothesize that there will be significant differences in levels of innate immunity between the groups.
Boston Medical Center is the lead sponsor of 314 studies on the registry; 34 are open to participants now.
Of its 34 completed or terminated interventional studies of FDA-regulated products, 28 (82%) have results posted.
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Healthy women, 18 to 40 years old, with spontaneous menstrual cycles or with normal ongoing pregnancy with gestational age between weeks 13 - 30 and able to provide informed consent
Exclusion Criteria:
Women with the following conditions will require rescheduling of the study visit:
Pregnant women with the following conditions at the time of examination will be excluded:
This cohort has completed accrual as of 12/28/11.
Other: Vaginal lavage specimen
Other: Vaginal lavage specimen
This cohort has completed accrual as of 12/28/11.
Other: Vaginal lavage specimen
This cohort has completed accrual as of 12/28/11.
Other: Vaginal lavage specimen
Collection of 3cc of saline used in the vagina to collect innate immunity markers
To compare the vaginal concentrations innate immunity markers (alpha / beta interferons, defensin, cathelicidin, lysozyme, lactoferrin, and SLPI) in pregnant and non-pregnant women who are HIV-negative.
Investigators will quantify the major vaginal innate immunity markers, including type 1 (alpha and beta) interferons, defensins, cathelicidins, lysozyme and lactoferrin, and secretory leukocyte protease inhibitor (SLPI). These antimicrobial host defense peptides are produced by genital tract mucosal epithelial cells and associated immune cells, and have a wide range of antiviral, antibacterial, antifungal and antiparasitic activities and modes of action. We hypothesize that changes in innate immunity markers take place during pregnancy, thereby changing native vaginal immunity.
Time frame: up to 2 clinic visits in 10 weeks
To compare the vaginal concentrations of innate immunity markers (alpha and beta) interferon, defensin, cathelicidin, lysozyme, lactoferrin, and SLPI)) in HIV-positive pregnant and non-pregnant women
Investigators will quantify the major vaginal innate immunity markers, including type 1 (alpha and beta) interferons, defensins, cathelicidins, lysozyme and lactoferrin, and secretory leukocyte protease inhibitor (SLPI). Women who have HIV may express different innate immunity marker profiles in vaginal secretions when pregnant as compared to non-pregnant HIV positive women. Timing of specimen collection: In pregnancy: Weeks 13 - 30. Non-pregnant: 3 weeks between menstrual bleeding cycles
Time frame: up to 2 clinic visits in 10 weeks
To compare the vaginal concentrations innate immunity markers (alpha / beta interferons, defensin, cathelicidin, lysozyme, lactoferrin, and SLPI) in pregnant women who are HIV-negative to pregnant women who are HIV-positive.
Investigators will quantify the major vaginal innate immunity markers, including type 1 (alpha and beta) interferons, defensins, cathelicidins, lysozyme and lactoferrin, and secretory leukocyte protease inhibitor (SLPI). Women with HIV may express different innate immunity marker profiles in vaginal secretions when pregnant as compared to pregnant, HIV-negative women. This may provide some explanation for differences in vaginal infection rates between the groups. Timing of specimen collection: In pregnancy: Weeks 13 - 30.
Time frame: up to 2 clinic visits in 10 weeks
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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