Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U36CCU300430-2239 | Other Grant/Funding Number | CDC | |
| U36CCU300430-1179 | Other Grant/Funding Number | CDC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Treatment | Active Comparator | oral (250mg three times daily for 7 days) metronidazole |
|
| Vaginal Treatment | Active Comparator | intravaginal (5 g of 0.75% gel twice daily for 5 days) metronidazole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral versus vaginal metronidazole | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Microbiological, Clinical, and Therapeutic Cure Rates at Follow-Up among Women Treated with Oral vs. Intravaginal Metronidazole | 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 | 4 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| preterm delivery | rate of delivery before 37 completed weeks gestation in intervention groups | at delivery |
| low birth weight | birth weight less than 2500 grams |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jane E Hitti, MD, MPH | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98185 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19951217 | Background | 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. | |
| 19515236 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016585 | Vaginosis, Bacterial |
| D047928 | Premature Birth |
| D001724 | Birth Weight |
| D002821 | Chorioamnionitis |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014627 | Vaginitis |
Not provided
Not provided
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.
Not provided
Not provided
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.
| at delivery |
| D014623 |
| Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005315 | Fetal Diseases |
| D005322 | Fetal Membranes, Premature Rupture |
| D010922 | Placenta Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |