Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy

Premature Birth Clinical Trial

Official title:

Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy (Randomized Trial of BV Treatment in Pregnancy)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00153517
• Other study ID #: CDC-NCCDPHP-2752
• Secondary ID: U36CCU300430-223
• Status: Completed
• Phase: Phase 2
• Start date: October 1999
• Est. completion date: September 2004

Study information

• Verified date: May 2024
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: September 2004
• Est. primary completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Chorioamnionitis
• Premature Birth
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Drug:
• oral versus vaginal metronidazole

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	preterm delivery	rate of delivery before 37 completed weeks gestation in intervention groups	at delivery
Secondary	low birth weight	birth weight less than 2500 grams	at delivery