The Role of Novel Organisms in Acute Endometritis

NCT ID: NCT01236131

Last Updated: 2016-08-17

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

480 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pelvic Inflammatory Disease

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Endometrial biospy samples

The Endometrial Biopsy samples will be provided by women enrolled in the University of Pittsburgh IRB PRO10010112 and PRO10010159

no intervention

Intervention Type OTHER

Not Applicable- no intervention

Interventions

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no intervention

Not Applicable- no intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* This is a laboratory research study involving the use of biologic specimens only.

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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

Sharon Hillier

OTHER

Sponsor Role lead

Responsible Party

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Sharon Hillier

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sharon L Hillier, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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Magee-Womens Research Institute

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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1U19AI084024-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PRO10080491

Identifier Type: -

Identifier Source: org_study_id

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