NCT04936373

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 23, 2021

Completed
Last Updated

December 18, 2023

Status Verified

December 1, 2023

Enrollment Period

4 months

First QC Date

June 12, 2021

Last Update Submit

December 15, 2023

Conditions

Health, Subjective

Outcome Measures

Primary Outcomes (3)

  • leg pain

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

    6 months

  • Breathlessness

    daily activities at work, home or social activities

    6 months

  • 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

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients were identified by searching the hospital database. Those who meet the inclusion criteria

You may qualify if:

  • 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

You may not qualify if:

  • death
  • an objective diagnostic tool could not be found to confirm the diagnosis
  • their event was not related to pregnancy
  • refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Al-Husban University Naser

Amman, 11941, Jordan

Location

The University of Jordan

Amman, 11942, Jordan

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 12, 2021

First Posted

June 23, 2021

Study Start

October 1, 2020

Primary Completion

January 20, 2021

Study Completion

March 2, 2021

Last Updated

December 18, 2023

Record last verified: 2023-12

Locations

JO(2)