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Vaginal and Rectal Clostridial Carriage Among Women of Reproductive Age in the United States

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT01283828
First received: January 25, 2011
Last updated: October 4, 2013
Last verified: October 2013
  Purpose

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.


Condition Phase
Clostridium Sordellii
Clostridium Perfringens
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vaginal and Rectal Clostridial Carriage Among Women of Reproductive Age in the United States

Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:
  • Prevalence of C sordellii or C perfringens carriage in the rectum/vagina [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of carriage of C sordellii or C perfringens [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Incidence of C. sordelli or C. perfringens carriage at 2 weeks after a negative test [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Vaginal and rectal swabs


Enrollment: 4977
Study Start Date: November 2010
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Approximately 5,000 women aged 18 to 45 years in the United States will be enrolled in the study. Women will be recruited from approximately 25 clinics and solo or group practices providing maternity care (pre- and post-natal), abortion, STI prevention & treatment, family planning, and student health services. All women will be recruited, excluding women seeking emergency or oncological care.

Criteria

Inclusion Criteria:

  • Willing and able to provide informed consent
  • Between ages 18 and 45

Exclusion Criteria:

-Seeking emergency or oncological care

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01283828

Locations
United States, Alabama
Montgomery Women's Health Associates
Montgomery, Alabama, United States, 36117
United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85721
United States, Colorado
Planned Parenthood of the Rocky Mountains
Boulder, Colorado, United States, 80302
UC Denver- Comprehensive Women's Health Center
Denver, Colorado, United States, 80220
United States, Georgia
Feminist Women's Center
Atlanta, Georgia, United States, 30329
United States, Illinois
Family Planning Associates Medical Group
Chicago, Illinois, United States, 60630
United States, Massachusetts
Planned Parenthood League of Massachusetts
Boston, Massachusetts, United States, 02215
United States, New Jersey
Women's Health Research Center
Plainsboro, New Jersey, United States, 08536
United States, New York
Mt Sinai Medical Center
New York, New York, United States, 10029
United States, North Dakota
Red River Women's Clinic
Fargo, North Dakota, United States, 58102
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
United States, Oregon
Downtown Gynecology
Portland, Oregon, United States, 97205
Downtown Women's Center
Portland, Oregon, United States, 97205
United States, Pennsylvania
Philadelphia Women's Center
Philadelphia, Pennsylvania, United States, 19106
United States, Texas
Whole Women's Health of Fort Worth
Fort Worth, Texas, United States, 76110
Dairy Ashford Family Practice
Houston, Texas, United States, 77077
Dr Barry Troyan
Houston, Texas, United States, 77043
United States, Washington
Cedar River Clinic
Seattle, Washington, United States, 98405
Sponsors and Collaborators
Gynuity Health Projects
Investigators
Principal Investigator: Beverly Winikoff, M.D., M.P.H. Gynuity Health Projects
  More Information

No publications provided

Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT01283828     History of Changes
Other Study ID Numbers: 7.2
Study First Received: January 25, 2011
Last Updated: October 4, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 24, 2014