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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04936373
Other study ID # Deanship Academic Research-T
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date March 2, 2021

Study information

Verified date December 2023
Source University of Jordan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date March 2, 2021
Est. primary completion date January 20, 2021
Accepts healthy volunteers
Gender Female
Age group 18 Years to 49 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Jordan Al-Husban University Naser Amman
Jordan The University of Jordan Amman

Sponsors (1)

Lead Sponsor Collaborator
University of Jordan

Country where clinical trial is conducted

Jordan, 

Outcome

Type Measure Description Time frame Safety issue
Primary leg pain limited mobility (difficulty walking, climbing stairs, bending, kneeling, squatting) 6 months
Primary Breathlessness daily activities at work, home or social activities 6 months
Primary difficulties completing duties at work Cut down the amount of time you spent on work or other activities , Accomplished less than you would like 6 months
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