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Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy
This study has been completed.
Study NCT00153517   Information provided by Centers for Disease Control and Prevention
First Received: September 8, 2005   No Changes Posted

September 8, 2005
September 8, 2005
October 1999
 
changes in vaginal flora
Same as current
No Changes Posted
  • preterm delivery
  • low birth weight
  • chorioamnionitis
Same as current
 
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:

  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.

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.

Phase II
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
  • Vaginosis, Bacterial
  • Premature Birth
  • Birth Weight
  • Chorioamnionitis
Drug: oral versus vaginal metronidazole
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
126
March 2005
 

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.

-

Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00153517
 
CDC-NCCDPHP-2752, U36CCU300430-2239, U36CCU300430-1179
Centers for Disease Control and Prevention
 
Principal Investigator: Jane E Hitti, MD, MPH University of Washington
Centers for Disease Control and Prevention
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP