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

NCT ID: NCT01283828

Last Updated: 2013-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4977 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2013-04-30

Brief Summary

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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

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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.

Conditions

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Clostridium Sordellii Clostridium Perfringens

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

-Seeking emergency or oncological care
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Gynuity Health Projects

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Beverly Winikoff, M.D., M.P.H.

Role: PRINCIPAL_INVESTIGATOR

Gynuity Health Projects

Locations

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Montgomery Women's Health Associates

Montgomery, Alabama, United States

Site Status

University of Arizona

Tucson, Arizona, United States

Site Status

Planned Parenthood of the Rocky Mountains

Boulder, Colorado, United States

Site Status

UC Denver- Comprehensive Women's Health Center

Denver, Colorado, United States

Site Status

Feminist Women's Center

Atlanta, Georgia, United States

Site Status

Family Planning Associates Medical Group

Chicago, Illinois, United States

Site Status

Planned Parenthood League of Massachusetts

Boston, Massachusetts, United States

Site Status

Women's Health Research Center

Plainsboro, New Jersey, United States

Site Status

Mt Sinai Medical Center

New York, New York, United States

Site Status

Red River Women's Clinic

Fargo, North Dakota, United States

Site Status

University of Cincinnati

Cincinnati, Ohio, United States

Site Status

Downtown Gynecology

Portland, Oregon, United States

Site Status

Downtown Women's Center

Portland, Oregon, United States

Site Status

Philadelphia Women's Center

Philadelphia, Pennsylvania, United States

Site Status

Whole Women's Health of Fort Worth

Fort Worth, Texas, United States

Site Status

Dr Barry Troyan

Houston, Texas, United States

Site Status

Dairy Ashford Family Practice

Houston, Texas, United States

Site Status

Cedar River Clinic

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 26942366 (View on PubMed)

Other Identifiers

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7.2

Identifier Type: -

Identifier Source: org_study_id