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Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial

Information source: Indiana University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bacterial Vaginosis

Intervention: Vaginal acidifying gel (RepHresh) (Drug); Metronidazole control (Drug)

Phase: N/A

Status: Completed

Sponsored by: Indiana University School of Medicine

Official(s) and/or principal investigator(s):
David M Haas, MD, Principal Investigator, Affiliation: Indiana University School of Medicine

Summary

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.

Clinical Details

Official title: Recurrent Bacterial Vaginosis (RBV): Efficiency of Metronidazole in Comparison to Metronidazole and Intravaginal Acidifying Gel: A Randomized Investigator-blinded Controlled Trial

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Recurrent Bacterial Vaginosis

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.

Criteria:

Inclusion Criteria: 1. All women of between 18-50 years of age. 2. Confirmed current diagnosis of BV using Amsel's criteria. 3. Women with at least total 2 confirmed episodes of BV including most recent episode (by Amsel's criteria) within a six month period or at least total three or more in the past twelve months Exclusion Criteria: 1. Patient who received antibiotic therapy within the past two weeks. 2. Patients who had co-existing gonorrhea or Chlamydia infection 3. Any contraindications or sensitivity to taking the vaginal gel. 4. Allergy to metronidazole 5. Alcoholics or those unable to abstain from alcohol consumption. 6. Pregnancy

Locations and Contacts

Indiana University School of Medicine, Indianapolis, Indiana 46202, United States
Additional Information

Starting date: September 2007
Last updated: January 6, 2010

Page last updated: August 23, 2015

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