The Role of Novel Organisms in Acute Endometritis

Completed

• Conditions: Pelvic Inflammatory Disease
• Interventions: Other: no intervention

• Registration Number: NCT01236131
• Lead Sponsor: Sharon Hillier

Brief Summary

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

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-04
• Study First Submitted QC: 2010-11-05
• Study First Posted: 2010-11-07
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-15
• Last Update Posted: 2016-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 480

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endometrial biospy samples	no intervention	The Endometrial Biopsy samples will be provided by women enrolled in the University of Pittsburgh IRB PRO10010112 and PRO10010159

Primary Outcome Measures

Name	Time	Method
Identification of Novel Organsims from PRO10010159	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	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).

Trial Locations

Locations (1)

Magee-Womens Research Institute; 🇺🇸 Pittsburgh, Pennsylvania, United States