Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial
Status:
Completed
Trial end date:
2009-07-01
Target enrollment:
Participant gender:
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.