The Role of Novel Organisms in Acute Endometritis

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01236131

Enrollment

480

Registered

2010-11-08

Start date

2010-11-30

Completion date

2015-08-31

Last updated

2016-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Inflammatory Disease

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.

Interventions

OTHERno intervention

Not Applicable- no intervention

Study design

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

15 Years to 40 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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).
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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026