NCT00545181

Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial

Recurrent Bacterial Vaginosis (RBV): Efficiency of Metronidazole in Comparison to Metronidazole and Intravaginal Acidifying Gel: A Randomized Investigator-blinded Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Indiana University School of Medicine · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bacterial Vaginosis

Interventions

Type	Name	Description
DRUG	Vaginal acidifying gel (RepHresh)	placement of vaginal acidifying gel into vagina to restore "normal" vaginal pH.
DRUG	Metronidazole control	oral metronidazole therapy alone

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2007-10-17
• Last updated: 2010-01-12
• Results posted: 2010-01-07

Locations

1 site across 1 country: United States