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Completed

NCT Number: NCT00153517

Maternal Effects of Bacterial Vaginosis (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.

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Key information

Conditions

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

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Washington

Seattle, Washington, 98185, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oral versus vaginal metronidazole

Drug

Primary outcomes

  1. Microbiological, Clinical, and Therapeutic Cure Rates at Follow-Up among Women Treated with Oral vs. Intravaginal Metronidazole

    Time frame: 4 weeks after treatment

    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

Secondary outcomes

  1. preterm delivery

    Time frame: at delivery

    rate of delivery before 37 completed weeks gestation in intervention groups

  2. low birth weight

    Time frame: at delivery

    birth weight less than 2500 grams

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Registry information

Official study title

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

Important dates

Study start
1999
Primary completion
2004
Study completion
2004
First posted
Sep 12, 2005
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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