Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy - Full Text View

Sponsor:	Centers for Disease Control and Prevention
Information provided by:	Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:	NCT00153517

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy (Randomized Trial of BV Treatment in Pregnancy)

Resource links provided by NLM:

Drug Information available for: Metronidazole hydrochloride Metronidazole phosphate Metronidazole

U.S. FDA Resources

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

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

Centers for Disease Control and Prevention

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 National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	CDC-NCCDPHP-2752, U36CCU300430-2239, U36CCU300430-1179
Study First Received:	September 8, 2005
Last Updated:	September 8, 2005
ClinicalTrials.gov Identifier:	NCT00153517 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:

Bacterial Vaginosis
Metronidazole

Additional relevant MeSH terms:

Birth Weight
Placenta Diseases
Bacterial Infections
Anti-Infective Agents
Metronidazole
Antiprotozoal Agents
Pregnancy Complications
Obstetric Labor, Premature
Physiological Effects of Drugs
Vaginitis
Obstetric Labor Complications
Vaginal Diseases

Fetal Membranes, Premature Rupture
Pharmacologic Actions
Genital Diseases, Female
Body Weight
Signs and Symptoms
Antiparasitic Agents
Fetal Diseases
Vaginosis, Bacterial
Radiation-Sensitizing Agents
Therapeutic Uses
Chorioamnionitis
Premature Birth

ClinicalTrials.gov processed this record on February 08, 2010