- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00153517
Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy
Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy (Randomized Trial of BV Treatment in Pregnancy)
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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Washington
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Seattle, Washington, United States, 98185
- University of Washington
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: African American, Hispanic, Asian/Pacific Islander, Native American, and white women.
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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.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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changes in vaginal flora
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Secondary Outcome Measures
Outcome Measure |
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preterm delivery
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low birth weight
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chorioamnionitis
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jane E Hitti, MD, MPH, University of Washington
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Body Weight
- Bacterial Infections
- Bacterial Infections and Mycoses
- Fetal Diseases
- Pregnancy Complications
- Fetal Membranes, Premature Rupture
- Obstetric Labor Complications
- Placenta Diseases
- Obstetric Labor, Premature
- Vaginitis
- Chorioamnionitis
- Premature Birth
- Birth Weight
- Vaginal Diseases
- Vaginosis, Bacterial
- Anti-Infective Agents
- Anti-Bacterial Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Metronidazole
Other Study ID Numbers
- CDC-NCCDPHP-2752
- U36CCU300430-2239
- U36CCU300430-1179
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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