Gynecology and Lubricant Effects (GALE) Study

The GALE study is a longitudinal study of the association between lubricant use and the vaginal microbiota in women receiving transvaginal ultrasound (TVUS) at the Diagnostic Radiology and Nuclear Medicine Department at the University of Maryland School of Medicine. Participants undergo a clinical exam at enrollment (at least 5 days prior to TVUS) and self-collect daily, mid-vaginal samples in the week leading up to TVUS, including immediately before the procedure. At the TVUS appointment, the sonographer applies a single-use packet of Glide lubricating jelly to the probe. The product was selected for study as it was currently being used in the TVUS clinic at the University of Maryland Medical Center and is a clinical lubricant which is very similar in composition to many sex lubricants. Participants collect samples the evening after TVUS and present for a follow-up clinical exam within a week of TVUS. Participants continue to sample twice weekly for an additional 8 weeks (returning completed kits each week), complete daily health and behavior diaries, and attend one final clinical exam at week 10. The clinician evaluates participants for bacterial vaginosis (BV) at each clinical visit using Amsel's criteria, and also looks for signs of vulvovaginal candidiasis (VVC) and trichomonas using a wet mount.]]>
English-speaking women aged 18 and older who were scheduled to receive a transvaginal ultrasound (TVUS) at the University of Maryland School of Medicine were recruited to the study. Exclusion criteria included current pregnancy, immunosuppression, diabetes mellitus, reported lubricant use within one week of TVUS appointment, reported antibiotic or antifungal use in the four weeks prior to TVUS appointment (including antibiotics or antifungals prescribed at the enrollment visit), positive for Neisseria gonorrhoeae, Chlamydia trachomatis, Trichomonas vaginalis, HIV, or syphilis at baseline, and diagnosis of menorrhagia, pelvic inflammatory disease, or cancers of the reproductive system following TVUS.]]>
This study was conducted between July 2017 and March 2020 at the University of Maryland School of Medicine in Baltimore, MD.]]>