Birth Weight, Chorioamnionitis, Premature Birth, Vaginosis, Bacterial
Conditions
Keywords
Bacterial Vaginosis, Metronidazole
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.
Interventions
DRUGoral versus vaginal metronidazole
Sponsors
Centers for Disease Control and Prevention
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The Investigational Drug Service at the University of Washington performed the randomization and provided the treatment assignments in opaque, sealed envelopes. Neither the subjects nor the study personnel assessing treatment effect were aware of which active agent had been assigned.
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.
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microbiological, Clinical, and Therapeutic Cure Rates at Follow-Up among Women Treated with Oral vs. Intravaginal Metronidazole | 4 weeks after treatment | Cure rates were assessed by Gram Stain Score (0-3, 4-6, 7-10); Abnormal clincial signs (0, 1-2, 3-4); Therapeutic cure (Gram Stain 0-3 and no symptoms) treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| preterm delivery | at delivery | rate of delivery before 37 completed weeks gestation in intervention groups |
| low birth weight | at delivery | birth weight less than 2500 grams |
Countries
United States
Outcome results
None listed