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Sponsored by: |
Indiana University School of Medicine |
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Information provided by: | Indiana University |
ClinicalTrials.gov Identifier: | NCT00545181 |
Bacterial vaginosis (BV) is a common, complex clinical syndrome characterized by alterations in the normal vaginal flora. Bacterial vaginosis has been associated with a variety of adverse health outcomes including endometritis; post-abortion endometritis; nongonococcal, nonchlamydial pelvic inflammatory disease; and an increased risk of acquiring and transmitting HIV infection. In pregnancy, BV is associated with premature rupture of the membranes, chorioamnionitis, amniotic fluid infection, preterm labor, preterm birth, and postpartum endometritis. Several studies have documented increased postpartum complications in the newborn and infants. The etiology of BV is poorly understood but recurrence is quite common despite treatment. Documented recurrence rate of up to 30% within three months are reported. Small studies have shown that adding vaginal acidifying gel to standard antibiotic regimens may reduce recurrence rates of BV. We plan an RCT comparing standard antibiotic therapy to antibiotics plus vaginal acidifying gel. Our hypothesis is that the addition of an acidifying gel will decrease the chance of recurrence of BV within 3 months.
Condition | Intervention |
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Bacterial Vaginosis |
Drug: Vaginal acidifying gel (RepHresh) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment |
Official Title: | Recurrent Bacterial Vaginosis (RBV): Efficiency of Metronidazole in Comparison to Metronidazole and Intravaginal Acidifying Gel: A Randomized Investigator-Blinded Controlled Trial |
Estimated Enrollment: | 160 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Receive metronidazole plus vaginal gel
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Drug: Vaginal acidifying gel (RepHresh)
placement of vaginal acidifying gel into vagina to restore "normal" vaginal pH.
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Women with recurrent BV will be randomly assigned to standard care of metronidazole vs metronidazole plus vaginal acidifying gel. Symptoms and presence of BV will be measured at followup.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: David M Haas, MD | 3176307837 | dahaas@iupui.edu |
United States, Indiana | |
Indiana University School of Medicine | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Principal Investigator: David M Haas, MD |
Principal Investigator: | David M Haas, MD | Indiana University School of Medicine |
Responsible Party: | Indiana University School of Medicine ( David M. Haas ) |
Study ID Numbers: | Study 0612-58 |
Study First Received: | October 15, 2007 |
Last Updated: | July 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00545181 |
Health Authority: | United States: Institutional Review Board |
bacterial vaginosis vaginal acidifying gel recurrence |
Genital Diseases, Female Bacterial Infections Metronidazole Vaginosis, Bacterial |
Vaginitis Vaginal Diseases Recurrence |