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Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial

NCT00545181 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2010-01-12

Study results available
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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.

Conditions

  • Bacterial Vaginosis

Interventions

DRUG

Vaginal acidifying gel (RepHresh)

placement of vaginal acidifying gel into vagina to restore "normal" vaginal pH.

DRUG

Metronidazole control

oral metronidazole therapy alone

Sponsors & Collaborators

  • Indiana University School of Medicine

    lead OTHER

Principal Investigators

  • David M Haas, MD · Indiana University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00545181 on ClinicalTrials.gov