The Role of Novel Organisms in Acute Endometritis

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sharon Hillier, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01236131
First received: November 4, 2010
Last updated: March 12, 2014
Last verified: March 2014
  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.

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Biospecimen Retention:   Samples With DNA

Endometrial biopsy specimens and isolates may be retained and stored in various registries such as:

  1. Human Microbiome Project
  2. J Craig Venture Institute
  3. PathoGene
  4. American Type Culture Collection
  5. 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
Study Population

Endometrial biopsy samples from women participating in University of Pittsburgh IRB PRO10010112 and PRO10010159

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01236131

Locations
United States, Pennsylvania
Magee-Womens Research Institute
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Sharon Hillier
Investigators
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: March 12, 2014
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 April 17, 2014