The Role of Novel Organisms in Acute Endometritis
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Purpose
The goal of this project is to identify the microorganisms present in the endometrial samples obtained from women with or without evidence of endometritis using a combination of culture methods, rRNA sequencing and whole genomic sequencing. The overarching aim of these studies is to identify the etiology of endometritis. The investigators will define the role of fastidious anaerobic microorganisms in the etiology of PID, and assess whether antibiotic treatment regimens used for the treatment of PID have activity against the novel organisms linked with pelvic infections.
| Condition | Intervention |
|---|---|
|
Pelvic Inflammatory Disease |
Other: no intervention |
| Study Type: | Observational |
| Study Design: | Time Perspective: Cross-Sectional |
| Official Title: | Characterization of Novel Organisms in the Genital Tract of Women With PID and Determination of Their Association With Endometritis. |
Endometrial biopsy specimens and isolates may be retained and stored in various registries such as:
- Human Microbiome Project
- J Craig Venture Institute
- PathoGene
- American Type Culture Collection
- CGS MindTouch Wiki hosted on Amazon's Elastic Compute Cloud (http://www.amazon.com/gp/browse.html?node-3435361)52 and will utilize MindTouch's Amazon Machine Image of their Wiki platform for rapid deployment
| Estimated Enrollment: | 450 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Endometrial biospy samples
The Endometrial Biopsy samples will be provided by women enrolled in the University of Pittsburgh IRB PRO10010112 and PRO10010159
|
Other: no intervention
Not Applicable- no intervention
|
Eligibility| Ages Eligible for Study: | 15 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Endometrial biopsy samples from women participating in University of Pittsburgh IRB PRO10010112 and PRO10010159
Inclusion Criteria:
- This is a laboratory research study involving the use of biologic specimens only.
- Specimens (endometrial biopsy samples) collected from subjects who meet the inclusion criteria for PRO10010159 and PRO10010112 will be utilized for this study.
Exclusion Criteria:
- Specimens (endometrial biopsy samples) that are collected from subjects enrolled in PRO10010159 and PRO10010112 that are insufficient will not be included in this study.
Contacts and Locations| United States, Pennsylvania | |
| Magee-Womens Research Institute | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: | Sharon L Hillier, PhD | University of Pittsburgh |
More Information
No publications provided
| Responsible Party: | Sharon Hillier, Professor, University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT01236131 History of Changes |
| Other Study ID Numbers: | PRO10080491, 1U19AI084024-01 |
| Study First Received: | November 4, 2010 |
| Last Updated: | February 29, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Endometritis Pelvic Inflammatory Disease Pelvic Infection Adnexal Diseases |
Genital Diseases, Female Uterine Diseases Infection |
ClinicalTrials.gov processed this record on May 22, 2013