NCT03748693

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2018

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

November 21, 2018

Status Verified

November 1, 2018

Enrollment Period

9 months

First QC Date

November 19, 2018

Last Update Submit

November 19, 2018

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (2)

  • Immune response in POP

    Tissue biopsy will analyzed for IMC and compared to control group

    Two weeks

  • Cytokine environment in POP

    Tissue biopsy will analyzed for cytokine environment and compared to control group

    Two weeks

Study Arms (2)

POP Group

Women with POP undergoing surgery in our OB/GYN department.

Procedure: Colporrhaphy

Non-POP Group

Women undergoing hysterectomy for other indications.

Procedure: Hysterectomy

Interventions

HysterectomyPROCEDURE

Surgery performed on women with a variety of gynecological indications

Non-POP Group
ColporrhaphyPROCEDURE

Surgery performed on women with POP

POP Group

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale(Gender-based eligibility)
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women attending our OB/GYN department because of POP and other gynecological disorders

You may qualify if:

  • Women with POP undergoing colporrhaphy
  • Women undergoing hysterectomy

You may not qualify if:

  • Autoimmune and connective tissue disorders
  • Cancer in genital tract

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

Hysterectomy

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Gynecologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Mariana Ordonez, MD

CONTACT

972-52-3243474malo_mariana@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2018

First Posted

November 21, 2018

Study Start

December 1, 2018

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

November 21, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share