Bacterial Vaginosis
Conditions
Keywords
bacterial vaginosis, vaginal acidifying gel, recurrence
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.
Interventions
DRUGVaginal acidifying gel (RepHresh)
placement of vaginal acidifying gel into vagina to restore normal vaginal pH.
DRUGMetronidazole control
oral metronidazole therapy alone
Sponsors
Indiana University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Metronidazole + Acidifying Gel (RepHresh) Receive metronidazole plus vaginal acidifying gel | 29 |
| Metronidazole Alone Metronidazole antibiotic therapy alone | 25 |
| Total | 54 |
Baseline characteristics
| Characteristic | Metronidazole Alone | Metronidazole + Acidifying Gel (RepHresh) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 29 Participants | 54 Participants |
| Age Continuous | 32.4 years STANDARD_DEVIATION 6.9 | 29.8 years STANDARD_DEVIATION 5.8 | 31.0 years STANDARD_DEVIATION 6.4 |
| Region of Enrollment United States | 25 participants | 29 participants | 54 participants |
| Sex: Female, Male Female | 25 Participants | 29 Participants | 54 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 29 | 0 / 25 |
| serious Total, serious adverse events | 0 / 29 | 0 / 25 |
Outcome results
Primary
Recurrent Bacterial Vaginosis
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.
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Metronidazole + Acidifying Gel (RepHresh) | Recurrent Bacterial Vaginosis | 7 Participants |
| Metronidazole Alone | Recurrent Bacterial Vaginosis | 7 Participants |
p-value: 0.75Chi-squared, Corrected