Vaginal and Rectal Clostridial Carriage Among Women of Reproductive Age in the United States
- Conditions
- Clostridium SordelliiClostridium Perfringens
- Registration Number
- NCT01283828
- Lead Sponsor
- Gynuity Health Projects
- Brief Summary
This primary goals of this study are to: estimate the prevalence of Clostridium sordellii and Clostridium perfringens carriage in the rectum and/or vagina among women of reproductive age; estimate duration of carriage of the two clostridium species; and estimate the incidence of carriage at 2 weeks after a negative test.
- Detailed Description
Since 2000, clostridial pelvic infections have claimed the lives of at least 17 young, previously healthy women. The majority of infections detected by molecular methods were among women testing positive for Clostridium sordellii only; in 5 cases, deaths were due to Clostridium perfringens only; and in 3 cases, the women were positive for both. These deaths occurred among both non-pregnant and recently pregnant women. Clostridium has been isolated from the vagina in 4-18% of normal, health non-pregnant women, with Clostridium perfringens the most common isolate. Most studies do not differentiate the small percentage of other clostridia present in the vaginal microenvironment. The vaginal carriage rate for Clostridium sordellii remains unknown, but is probably very low, less than 1%.
The correlates of clostridial carriage are unknown, and data on the etiology and lethality of clostridial infection among women of reproductive age are insufficient to guide possible courses of safe and effective prevention. In women infected with strains of Clostridium perfringens and Clostridium sordellii that produce the lethal toxin, it is not clear whether there is an effective treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 4977
- Willing and able to provide informed consent
- Between ages 18 and 45
-Seeking emergency or oncological care
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prevalence of C sordellii or C perfringens carriage in the rectum/vagina 2 years
- Secondary Outcome Measures
Name Time Method Duration of carriage of C sordellii or C perfringens 2 years Incidence of C. sordelli or C. perfringens carriage at 2 weeks after a negative test 2 years
Trial Locations
- Locations (18)
Montgomery Women's Health Associates
🇺🇸Montgomery, Alabama, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
Mt Sinai Medical Center
🇺🇸New York, New York, United States
Planned Parenthood of the Rocky Mountains
🇺🇸Boulder, Colorado, United States
UC Denver- Comprehensive Women's Health Center
🇺🇸Denver, Colorado, United States
Women's Health Research Center
🇺🇸Plainsboro, New Jersey, United States
Red River Women's Clinic
🇺🇸Fargo, North Dakota, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Downtown Women's Center
🇺🇸Portland, Oregon, United States
Whole Women's Health of Fort Worth
🇺🇸Fort Worth, Texas, United States
Feminist Women's Center
🇺🇸Atlanta, Georgia, United States
Family Planning Associates Medical Group
🇺🇸Chicago, Illinois, United States
Planned Parenthood League of Massachusetts
🇺🇸Boston, Massachusetts, United States
Philadelphia Women's Center
🇺🇸Philadelphia, Pennsylvania, United States
Dr Barry Troyan
🇺🇸Houston, Texas, United States
Dairy Ashford Family Practice
🇺🇸Houston, Texas, United States
Cedar River Clinic
🇺🇸Seattle, Washington, United States
Downtown Gynecology
🇺🇸Portland, Oregon, United States