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Quality of Life of Patients With Pregnancy Related VTE

Sponsor
University of Jordan (Other)
Overall Status
Completed
CT.gov ID
NCT04936373
Collaborator
(none)
112
Enrollment
2
Locations
5
Actual Duration (Months)
56
Patients Per Site
11.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A retrospective study of the quality of life and problems experienced by patients who developed pregnancy related VTE. It involves patients seen at JUH in 2012-2020. A questionnaire will be filled by those patients and any other patients in Jordan. It was translated to an Arabic form from EQ-5D, VEINES-QOL/SYM questionnaire and PEmb-QoL. The quality of their lives will be assessed and the problems encountered are going to be analyzed to try to find some solutions. This project is going to be a national research project with the efforts to try to find common platforms for those patients and nidus to establish a national support group.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Retrospective study and analysis using a questionnaire which will be distributed to patients. The patients' data and contact details (phone numbers, whatsApp, email address…) will be collected from their clinical records at the JUH hospital. The period 2012-2020 will be covered. The questionnaire link is; file:///C:/Users/user/Downloads/QoL-post-VTE-during-pregnancy-5.pdf and file:///C:/Users/user/Downloads/arabic%20questionnaire%20last%201.pdf

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    112 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Pregnancy-related VTE; Quality of Patients' Lives
    Actual Study Start Date :
    Oct 1, 2020
    Actual Primary Completion Date :
    Jan 20, 2021
    Actual Study Completion Date :
    Mar 2, 2021

    Outcome Measures

    Primary Outcome Measures

    1. leg pain [6 months]

      limited mobility (difficulty walking, climbing stairs, bending, kneeling, squatting)

    2. Breathlessness [6 months]

      daily activities at work, home or social activities

    3. difficulties completing duties at work [6 months]

      Cut down the amount of time you spent on work or other activities , Accomplished less than you would like

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • pregnancy related event

    • confirmed diagnosis by an objective diagnostic tool (Duplex ultrasonography, CT pulmonary angiography, spiral CT scan or ventilation perfusion scan)

    • consent (acceptance) to participate was obtained

    • alive patients

    Exclusion Criteria:

    • death

    • an objective diagnostic tool could not be found to confirm the diagnosis

    • their event was not related to pregnancy

    • refusal to participate

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Al-Husban University Naser Amman Jordan 11941
    2 The University of Jordan Amman Jordan 11942

    Sponsors and Collaborators

    • University of Jordan

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Naser Al-Husban, Assistant Professor, Jordan University Hospital
    ClinicalTrials.gov Identifier:
    NCT04936373
    Other Study ID Numbers:
    • Deanship Academic Research-T
    First Posted:
    Jun 23, 2021
    Last Update Posted:
    Jun 23, 2021
    Last Verified:
    Jan 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jun 23, 2021