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Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00153517
First Posted: September 12, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Centers for Disease Control and Prevention
  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:

  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.

Condition Intervention Phase
Vaginosis, Bacterial Premature Birth Birth Weight Chorioamnionitis Drug: oral versus vaginal metronidazole Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy (Randomized Trial of BV Treatment in Pregnancy)

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • changes in vaginal flora

Secondary Outcome Measures:
  • preterm delivery
  • low birth weight
  • chorioamnionitis

Estimated Enrollment: 126
Study Start Date: October 1999
Estimated Study Completion Date: March 2005
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00153517


Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98185
Sponsors and Collaborators
Centers for Disease Control and Prevention
Investigators
Principal Investigator: Jane E Hitti, MD, MPH University of Washington
  More Information

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
First Submitted: September 8, 2005
First Posted: September 12, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

Keywords provided by Centers for Disease Control and Prevention:
Bacterial Vaginosis
Metronidazole

Additional relevant MeSH terms:
Birth Weight
Vaginal Diseases
Vaginosis, Bacterial
Premature Birth
Chorioamnionitis
Body Weight
Signs and Symptoms
Genital Diseases, Female
Bacterial Infections
Vaginitis
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Fetal Diseases
Fetal Membranes, Premature Rupture
Placenta Diseases
Metronidazole
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents


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