Clinical trial NCT00153517: Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy
Official title: Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy (Randomized Trial of BV Treatment in Pregnancy)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vaginosis, Bacterial
Premature Birth
Birth Weight
Chorioamnionitis
Keywords: Bacterial Vaginosis
Metronidazole
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
First posted: 2005-09-12
Enrollment: 126
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: study participants were randomized to treatment with oral metronidazole (Centers for Disease Control and Prevention \[CDC\] recommended regimen: 250mg three times daily for 7 days) plus intravaginal placebo or intravaginal metronidazole (5 g of 0.75% gel twice daily for 5 days) plus oral placebo. The oral and vaginal placebos were indistinguishable from active therapy. Randomization to study group used random number tables, with a 1:1 ratio between study groups.
Primary purpose: TREATMENT

Brief summary: The goal of this study is to examine acceptability and efficacy of 2 kinds of BV treatment among women at low risk for preterm delivery. The objectives are:

1. To examine the side effects and patient acceptability of oral versus intravaginal metronidazole.
2. To compare the efficacy of oral and intravaginal metronidazole for the treatment of BV
3. To study the efficacy of oral and intravaginal metronidazole for the prevention of hospital admission during the 3rd trimester, chorioamnionitis, preterm delivery, and maternal infectious morbidity.

Detailed description: This is a randomized, placebo-controlled intervention trial. Women diagnosed as BV+ by Gram stain at 12-16 weeks gestation are randomly assigned to the following treatment groups: oral metronidazole (250 mg TID x 7 days) with intravaginal placebo; intravaginal metronidazole (5g 0.75% gel BID x 5 days) with oral placebo. African American, Hispanic, Asian/Pacific Islander, Native American, and white women are eligible. Women with a prior preterm delivery, multiple gestation, chronic hypertension or pre-existing diabetes, antibiotic use before enrollment in the study, allergy to metronidazole, history of alcohol abuse in past year, and women under age 18 are excluded.

Eligibility criteria: Inclusion Criteria:

* Tested positive for bacerial vaginosis (Nugent score \>7)
* African American, Hispanic, Asian/Pacific Islander, Native American, and white women

Exclusion Criteria:

* \>20 weeks gestaion
* history of preterm delivery
* had a multiple gestation pregnancy
* had major medical complications (e.g., chronic hypertension or pre-existing diabetes)
* antibiotic use within 7 days of screening visit for enrollment in the study,
* allergy to metronidazole
* history of alcohol dependency in past year women under age 16

Primary outcomes:
measure: Microbiological, Clinical, and Therapeutic Cure Rates at Follow-Up among Women Treated with Oral vs. Intravaginal Metronidazole
timeFrame: 4 weeks after treatment
Secondary outcomes:
measure: preterm delivery
timeFrame: at delivery
measure: low birth weight
timeFrame: at delivery
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Jane E Hitti, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mitchell C, Balkus J, Agnew K, Lawler R, Hitti J. Changes in the vaginal microenvironment with metronidazole treatment for bacterial vaginosis in early pregnancy. J Womens Health (Larchmt). 2009 Nov;18(11):1817-24. doi: 10.1089/jwh.2009.1378.
citation: Mitchell CM, Hitti JE, Agnew KJ, Fredricks DN. Comparison of oral and vaginal metronidazole for treatment of bacterial vaginosis in pregnancy: impact on fastidious bacteria. BMC Infect Dis. 2009 Jun 10;9:89. doi: 10.1186/1471-2334-9-89.