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The Role of Novel Organisms in Acute Endometritis

This study has been completed.
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Sharon Hillier, University of Pittsburgh Identifier:
First received: November 4, 2010
Last updated: August 15, 2016
Last verified: August 2016
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 Sharon Hillier, University of Pittsburgh:

Primary Outcome Measures:
  • Identification of Novel Organsims from PRO10010159 [ Time Frame: 12 months after participant enrollment in PRO10010159 ]
    This study will use optimized culture methods which can support the growth of fastidious organisms to describe the microorganisms in endometrial tissue samples obtained from the 200 women enrolled in the cervicitis cohort (PRO10010159, T Cell Response).

  • Identification of Novel Organisms from PRO10010112 [ Time Frame: 30 days after participant enrollment in PRO10010112 ]
    This study will use optimized culture methods which can support the growth of fastidious organisms to describe the microorganisms in endometrial tissue samples obtained from 250 women enrolled in the acute PID study before and after treatment (PRO10010112, Acute PID treatment).

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 ( and will utilize MindTouch's Amazon Machine Image of their Wiki platform for rapid deployment

Enrollment: 480
Study Start Date: November 2010
Study Completion Date: August 2015
Primary Completion Date: August 2015 (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


Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes 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

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.
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Please refer to this study by its identifier: NCT01236131

United States, Pennsylvania
Magee-Womens Research Institute
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Sharon Hillier
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Sharon L Hillier, PhD University of Pittsburgh
  More Information

Responsible Party: Sharon Hillier, Professor, University of Pittsburgh Identifier: NCT01236131     History of Changes
Other Study ID Numbers: PRO10080491
1U19AI084024-01 ( US NIH Grant/Contract Award Number )
Study First Received: November 4, 2010
Last Updated: August 15, 2016

Additional relevant MeSH terms:
Pelvic Inflammatory Disease
Pelvic Infection
Adnexal Diseases
Genital Diseases, Female
Uterine Diseases
Infection processed this record on May 25, 2017