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Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy

2014-07-23 21:48:51 | BioPortfolio

Summary

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.

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.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Vaginosis, Bacterial

Intervention

oral versus vaginal metronidazole

Location

University of Washington
Seattle
Washington
United States
98185

Status

Completed

Source

Centers for Disease Control and Prevention

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:48:51-0400

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Medical and Biotech [MESH] Definitions

A genus of bacteria found in the human genital and urinary tract. It is considered to be a major cause of bacterial vaginosis (VAGINOSIS, BACTERIAL).

The only species in the genus GARDNERELLA, and previously classed as Haemophilus vaginalis. This bacterium, also isolated from the female genital tract of healthy women, is implicated in the cause of bacterial vaginosis (VAGINOSIS, BACTERIAL). It occasionally causes postpartum bacteremia and bacteremia following a transurethral resection of the prostate.

A genus of gram-negative, anaerobic, rod-shaped bacteria. Its organisms are found in the human vagina, particularly in association with Gardnerella vaginalis in cases of bacterial vaginosis.

A species of Lactobacillus that occurs in the human GASTROINTESTINAL TRACT and the VAGINA of healthy women. It produces LACTIC ACID and HYDROGEN PEROXIDE, and is used as a PROBIOTIC. It is also used for the treatment and prevention of BACTERIAL VAGINOSIS.

The uptake of substances from the VAGINA via the vaginal epithelium/mucosa.

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