Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy
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Purpose
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:
- To examine the side effects and patient acceptability of oral versus intravaginal metronidazole.
- To compare the efficacy of oral and intravaginal metronidazole for the treatment of BV
- 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Vaginosis, Bacterial Premature Birth Birth Weight Chorioamnionitis |
Drug: oral versus vaginal metronidazole |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy (Randomized Trial of BV Treatment in Pregnancy) |
- changes in vaginal flora
- preterm delivery
- low birth weight
- chorioamnionitis
| Estimated Enrollment: | 126 |
| Study Start Date: | October 1999 |
| Estimated Study Completion Date: | March 2005 |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria: African American, Hispanic, Asian/Pacific Islander, Native American, and white women.
-
Exclusion Criteria: 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.
-
Contacts and Locations More Information
No publications provided by Centers for Disease Control and Prevention
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00153517 History of Changes |
| Other Study ID Numbers: | CDC-NCCDPHP-2752, U36CCU300430-2239, U36CCU300430-1179 |
| Study First Received: | September 8, 2005 |
| Last Updated: | September 8, 2005 |
| Health Authority: | United States: Federal Government |
Keywords provided by Centers for Disease Control and Prevention:
|
Bacterial Vaginosis Metronidazole |
Additional relevant MeSH terms:
|
Birth Weight Chorioamnionitis Vaginosis, Bacterial Premature Birth Body Weight Signs and Symptoms Fetal Diseases Pregnancy Complications Fetal Membranes, Premature Rupture Obstetric Labor Complications Placenta Diseases Bacterial Infections |
Vaginitis Vaginal Diseases Genital Diseases, Female Obstetric Labor, Premature Metronidazole Radiation-Sensitizing Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Infective Agents Therapeutic Uses Antiprotozoal Agents Antiparasitic Agents |
ClinicalTrials.gov processed this record on May 23, 2013