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Inflammation and Cellular Immunity in Vaginal Tissue in Patients With Pelvic Organ Prolapse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03748693
Recruitment Status : Not yet recruiting
First Posted : November 21, 2018
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

Brief Summary:

The aim of this study is to investigate the inflammatory and maturation processes of immature myeloid cells (IMC) in the vaginal tissue in women with advanced pelvic organ prolapse (POP) (stage III-IV) and in normal non-POP controls.

We hypothesize that the processes contributing to POP may be related to immune response and changes in myeloid cell populations and the cytokine environment.


Condition or disease Intervention/treatment
Pelvic Organ Prolapse Procedure: Hysterectomy Procedure: Colporrhaphy

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Inflammation and Cellular Immunity in Vaginal Tissue in Patients With Pelvic Organ Prolapse
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
POP Group
Women with POP undergoing surgery in our OB/GYN department.
Procedure: Colporrhaphy
Surgery performed on women with POP

Non-POP Group
Women undergoing hysterectomy for other indications.
Procedure: Hysterectomy
Surgery performed on women with a variety of gynecological indications




Primary Outcome Measures :
  1. Immune response in POP [ Time Frame: Two weeks ]
    Tissue biopsy will analyzed for IMC and compared to control group

  2. Cytokine environment in POP [ Time Frame: Two weeks ]
    Tissue biopsy will analyzed for cytokine environment and compared to control group



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Sampling Method:   Probability Sample
Study Population
Women attending our OB/GYN department because of POP and other gynecological disorders
Criteria

Inclusion Criteria:

  • Women with POP undergoing colporrhaphy
  • Women undergoing hysterectomy

Exclusion Criteria:

  • Autoimmune and connective tissue disorders
  • Cancer in genital tract

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03748693


Contacts
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Contact: Mariana Ordonez, MD 972-52-3243474 malo_mariana@hotmail.com

Sponsors and Collaborators
Hillel Yaffe Medical Center
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Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT03748693    
Other Study ID Numbers: HYMC-0073-18
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Inflammation
Prolapse
Pelvic Organ Prolapse
Pathologic Processes
Pathological Conditions, Anatomical