drugset / Trial / NCT00153517
Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 1999-10
- Primary completion
- 2004-09
- Completion
- 2004-09
Publications
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Metronidazole | Small molecule | 250 mg | Oral |
| Comparator | Metronidazole | Small molecule | 5 g | Oral |