Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy

NCT00153517 | Completed Phase 2 DMC FDA Drug

• 3 other identifiers: CDC-NCCDPHP-2752U36CCU300430-2239U36CCU300430-1179
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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. 1.To examine the side effects and patient acceptability of oral versus intravaginal metronidazole.
2. 2.To compare the efficacy of oral and intravaginal metronidazole for the treatment of BV
3. 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.

Conditions

Vaginosis, Bacterial; Premature Birth; Birth Weight; Chorioamnionitis

Keywords

Bacterial Vaginosis; Metronidazole

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• preterm delivery

  at delivery

• low birth weight

  at delivery

Study Arms (2)

Oral Treatment

ACTIVE COMPARATOR

oral (250mg three times daily for 7 days) metronidazole

Drug: oral versus vaginal metronidazole

Vaginal Treatment

ACTIVE COMPARATOR

intravaginal (5 g of 0.75% gel twice daily for 5 days) metronidazole

Drug: oral versus vaginal metronidazole

Interventions

oral versus vaginal metronidazole DRUG

Oral Treatment; Vaginal Treatment

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \>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

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98185, United States

Location

Related 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.

  PMID: 19951217 BACKGROUND

• 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.

  PMID: 19515236 BACKGROUND

MeSH Terms

Conditions

Vaginosis, Bacterial; Premature Birth; Birth Weight; Chorioamnionitis

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fetal Diseases; Fetal Membranes, Premature Rupture; Placenta Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jane E Hitti, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Investigational Drug Service at the University of Washington performed the randomization and provided the treatment assignments in opaque, sealed envelopes. Neither the subjects nor the study personnel assessing treatment effect were aware of which active agent had been assigned.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lead Health Scientist

Model Details: study participants were randomized to treatment with oral metronidazole (Centers for Disease Control and Prevention \[CDC\] recommended regimen: 250mg three times daily for 7 days) plus intravaginal placebo or intravaginal metronidazole (5 g of 0.75% gel twice daily for 5 days) plus oral placebo. The oral and vaginal placebos were indistinguishable from active therapy. Randomization to study group used random number tables, with a 1:1 ratio between study groups.

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: October 1, 1999
• Primary Completion: September 1, 2004
• Study Completion: September 1, 2004
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)