A Prospective Longitudinal Data Bank Creation to Study Vaginal Conditions With a Novel Diagnostic Approach

What this Trial Is About

This research aims to understand the role of unusual proteins, cytokines, and vaginal microbial flora in causing vulvodynia, recurrent fungal and bacterial vaginosis, and preterm labor. The study compares these factors in different groups of women to uncover how changes in the vaginal environment might lead to symptoms like irritation, pain, and infection recurrence, as well as premature birth. Researchers will use a multidisciplinary approach involving microbiology, proteomics, and cytokine analysis to explore these mechanisms. Participants include four groups of women aged 21 to 75 years: healthy non-pregnant women without a history of vulvovaginal conditions, non-pregnant women with vulvovaginal issues, healthy pregnant women, and pregnant women with vulvovaginal conditions. Vaginal samples will be collected using cotton swabs from the middle vagina, processed for microbiological and biochemical testing including cytokine and protein levels. Pregnant women will have samples collected up to four times over 12 months. During the study, participants will provide informed consent and complete a comprehensive history related to environmental factors and vulvovaginal health. Researchers will measure cytokines, proteins, and vaginal lactobacillus levels from collected samples. Data will be kept confidential and stored securely. The main outcome is cytokine determination, with secondary outcomes including protein and lactobacillus analysis. The study aims to create a data bank to support future research, with participation lasting according to sample collection schedules.

Prospective Data Bank Creation to Study Vaginal Conditions