Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy

This study has been completed.
Sponsor:
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00153517
First received: September 8, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  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
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)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00153517

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98185
Sponsors and Collaborators
Investigators
Principal Investigator: Jane E Hitti, MD, MPH University of Washington
  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
Premature Birth
Vaginosis, Bacterial
Bacterial Infections
Body Weight
Fetal Diseases
Fetal Membranes, Premature Rupture
Genital Diseases, Female
Obstetric Labor Complications
Obstetric Labor, Premature
Placenta Diseases
Pregnancy Complications
Signs and Symptoms
Vaginal Diseases
Vaginitis
Metronidazole
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014