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

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.

Study Overview

• Status: Completed
• Conditions: Clostridium Sordellii; Clostridium Perfringens

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.

• Study Type: Observational
• Enrollment (Actual): 4977

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

-Seeking emergency or oncological care

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Prevalence of C sordellii or C perfringens carriage in the rectum/vagina	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Gynuity Health Projects
• Investigators: Principal Investigator: Beverly Winikoff, M.D., M.P.H., Gynuity Health Projects

Publications and helpful links

General Publications

• Chong E, Winikoff B, Charles D, Agnew K, Prentice JL, Limbago BM, Platais I, Louie K, Jones HE, Shannon C; NCT01283828 Study Team. Vaginal and Rectal Clostridium sordellii and Clostridium perfringens Presence Among Women in the United States. Obstet Gynecol. 2016 Feb;127(2):360-8. doi: 10.1097/AOG.0000000000001239.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: January 25, 2011
• First Submitted That Met QC Criteria: January 25, 2011
• First Posted (Estimate): January 26, 2011

Study Record Updates

• Last Update Posted (Estimate): October 7, 2013
• Last Update Submitted That Met QC Criteria: October 4, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 7.2