Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial

Not Applicable

Completed

• Conditions: Bacterial Vaginosis
• Interventions: Drug: Vaginal acidifying gel (RepHresh); Drug: Metronidazole control

• Registration Number: NCT00545181
• Lead Sponsor: Indiana University School of Medicine

Brief 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.

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.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-10-15
• Study First Submitted QC: 2007-10-16
• Study First Posted: 2007-10-17
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Results First Submitted: 2009-12-02
• Results First Submitted QC: 2009-12-02
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-06
• Results First Posted: 2010-01-07
• Last Update Posted: 2010-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metronidazole plus gel	Vaginal acidifying gel (RepHresh)	Receive metronidazole plus vaginal gel
Control- metronidazole alone	Metronidazole control	Oral Metronidazole antibiotic therapy alone

Primary Outcome Measures

Name	Time	Method
Recurrent Bacterial Vaginosis	3 months	Recurrence by either Amsel's or Nugent's criteria. Amsel's criteria are the presence of 3 of 4 of following: 1. homogenous gray-white vaginal discharge, 2. elevated vaginal pH \>4.7, 3. presence of at least 20% of vaginal epithelial cells being clue cells on wet prep microscopy, and 4. positive amine odor test on addition of 10% KOH. Nugent's criteria is based on microscopy and bacterial scoring of lactobaccilus, gardnerella, and curved gram-variable rods. A score of at least 7 is indicative of bacterial vaginosis.

Trial Locations

Locations (1)

Indiana University School of Medicine; 🇺🇸 Indianapolis, Indiana, United States