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Completed

NCT Number: NCT01236131

The Role of Novel Organisms in Acute Endometritis

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.

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Key information

Conditions

Pelvic Inflammatory Disease Adnexal Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Pelvic Infection Urogenital Diseases

Age range

15 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Magee-Womens Research Institute

Pittsburgh, Pennsylvania, 15213, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

Not Applicable- no intervention

Primary outcomes

  1. 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).

  2. 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).

Sponsors and collaborators

Lead sponsor

Sharon Hillier

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

Characterization of Novel Organisms in the Genital Tract of Women With PID and Determination of Their Association With Endometritis.

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Nov 8, 2010
Registry last updated
Aug 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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