Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial

Study 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.

Primary Outcome

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

Interventions

• DRUG Vaginal acidifying gel (RepHresh)
• DRUG Metronidazole control