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.

Study Overview

• Status: Completed
• Conditions: Premature Birth; Chorioamnionitis; Birth Weight; Vaginosis, Bacterial
• Intervention / Treatment: Drug: oral versus vaginal metronidazole

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.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98185
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Tested positive for bacerial vaginosis (Nugent score >7)
• African American, Hispanic, Asian/Pacific Islander, Native American, and white women

Exclusion Criteria:

• >20 weeks gestaion
• history of preterm delivery
• had a multiple gestation pregnancy
• had major medical complications (e.g., chronic hypertension or pre-existing diabetes)
• antibiotic use within 7 days of screening visit for enrollment in the study,
• allergy to metronidazole
• history of alcohol dependency in past year women under age 16

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Oral Treatment; oral (250mg three times daily for 7 days) metronidazole	Drug: oral versus vaginal metronidazole
Active Comparator: Vaginal Treatment; intravaginal (5 g of 0.75% gel twice daily for 5 days) metronidazole	Drug: oral versus vaginal metronidazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiological, Clinical, and Therapeutic Cure Rates at Follow-Up among Women Treated with Oral vs. Intravaginal Metronidazole	Cure rates were assessed by Gram Stain Score (0-3, 4-6, 7-10); Abnormal clincial signs (0, 1-2, 3-4); Therapeutic cure (Gram Stain 0-3 and no symptoms) treatment	4 weeks after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
preterm delivery	rate of delivery before 37 completed weeks gestation in intervention groups	at delivery
low birth weight	birth weight less than 2500 grams	at delivery

Collaborators and Investigators

• Sponsor: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Jane E Hitti, MD, MPH, University of Washington

Publications and helpful links

General Publications

• Mitchell C, Balkus J, Agnew K, Lawler R, Hitti J. Changes in the vaginal microenvironment with metronidazole treatment for bacterial vaginosis in early pregnancy. J Womens Health (Larchmt). 2009 Nov;18(11):1817-24. doi: 10.1089/jwh.2009.1378.
• 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. doi: 10.1186/1471-2334-9-89.

Study record dates

Study Major Dates

• Study Start: October 1, 1999
• Primary Completion (Actual): September 1, 2004
• Study Completion (Actual): September 1, 2004

Study Registration Dates

• First Submitted: September 8, 2005
• First Submitted That Met QC Criteria: September 8, 2005
• First Posted (Estimated): September 12, 2005

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 28, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Metronidazole; Bacterial Vaginosis
• Additional Relevant MeSH Terms: Infections; Body Weight; Bacterial Infections; Bacterial Infections and Mycoses; Fetal Diseases; Pregnancy Complications; Fetal Membranes, Premature Rupture; Obstetric Labor Complications; Placenta Diseases; Obstetric Labor, Premature; Vaginitis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Chorioamnionitis; Premature Birth; Birth Weight; Vaginal Diseases; Vaginosis, Bacterial; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole
• Other Study ID Numbers: CDC-NCCDPHP-2752; U36CCU300430-2239 (Other Grant/Funding Number: CDC); U36CCU300430-1179 (Other Grant/Funding Number: CDC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No