Clinical trial NCT01283828: Vaginal and Rectal Clostridial Carriage Among Women of Reproductive Age in the United States
Official title: Vaginal and Rectal Clostridial Carriage Among Women of Reproductive Age in the United States
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clostridium Sordellii
Clostridium Perfringens
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
First posted: 2011-01-26
Enrollment: 4977
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-Seeking emergency or oncological care

Primary outcomes:
measure: Prevalence of C sordellii or C perfringens carriage in the rectum/vagina
timeFrame: 2 years
Secondary outcomes:
measure: Duration of carriage of C sordellii or C perfringens
timeFrame: 2 years
measure: Incidence of C. sordelli or C. perfringens carriage at 2 weeks after a negative test
timeFrame: 2 years
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Montgomery Women's Health Associates
state: Alabama
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Boulder
country: United States
facility: Planned Parenthood of the Rocky Mountains
state: Colorado
city: Denver
country: United States
facility: UC Denver- Comprehensive Women's Health Center
state: Colorado
city: Atlanta
country: United States
facility: Feminist Women's Center
state: Georgia
city: Chicago
country: United States
facility: Family Planning Associates Medical Group
state: Illinois
city: Boston
country: United States
facility: Planned Parenthood League of Massachusetts
state: Massachusetts
city: Plainsboro
country: United States
facility: Women's Health Research Center
state: New Jersey
city: New York
country: United States
facility: Mt Sinai Medical Center
state: New York
city: Fargo
country: United States
facility: Red River Women's Clinic
state: North Dakota
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Portland
country: United States
facility: Downtown Gynecology
state: Oregon
city: Portland
country: United States
facility: Downtown Women's Center
state: Oregon
city: Philadelphia
country: United States
facility: Philadelphia Women's Center
state: Pennsylvania
city: Fort Worth
country: United States
facility: Whole Women's Health of Fort Worth
state: Texas
city: Houston
country: United States
facility: Dr Barry Troyan
state: Texas
city: Houston
country: United States
facility: Dairy Ashford Family Practice
state: Texas
city: Seattle
country: United States
facility: Cedar River Clinic
state: Washington
Study officials:
affiliation: Gynuity Health Projects
name: Beverly Winikoff, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.