Health, SubjectiveNCT04936373
Quality of Life of Patients With Pregnancy Related VTE
An observational study of Health, Subjective, run by University of Jordan at 2 sites in Jordan.
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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Health, Subjective
- How many people
- 112 participants
- Where
- 2 sitesJordan
- Study dates
- 1 Oct 2020to 2 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Adult
Study population: Patients were identified by searching the hospital database. Those who meet the inclusion criteria
Who may be able to join
- 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
Who cannot join
- death
- an objective diagnostic tool could not be found to confirm the diagnosis
- their event was not related to pregnancy
- refusal to participate
Trial locations and contacts
2 sites in 1 country.
Jordan2 sites
Al-Husban University Naser
Amman, 11941
The University of Jordan
Amman, 11942
About this study
Official title: Pregnancy-related VTE; Quality of Patients' Lives
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.
Read the 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
- Conditions
- Health, Subjective
What is being measured
The primary outcome is the main question the study is designed to answer.
leg pain
limited mobility (difficulty walking, climbing stairs, bending, kneeling, squatting)
Measured: 6 months
Breathlessness
daily activities at work, home or social activities
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start1 Oct 2020
- Primary completion20 Jan 2021
- Study completion2 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health, SubjectiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naser Al-Husban, Jordan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936373
- Sponsor's protocol ID
- Deanship Academic Research-T
- Status last verified
- Dec 2023
- First submitted
- 12 Jun 2021
- Last updated
- 18 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy-related VTE; Quality of Patients' Lives
- ClinicalTrials.gov ID
- NCT04936373
- Acronym / sponsor ID
- Deanship Academic Research-T
- Conditions
- Health, Subjective
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 20 Jan 2021 (actual)
- Study completion
- 2 Mar 2021 (actual)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Patients were identified by searching the hospital database. Those who meet the inclusion criteria
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- death
- an objective diagnostic tool could not be found to confirm the diagnosis
- their event was not related to pregnancy
- refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
leg pain
Time frame: 6 months
limited mobility (difficulty walking, climbing stairs, bending, kneeling, squatting)
Breathlessness
Time frame: 6 months
daily activities at work, home or social activities
difficulties completing duties at work
Time frame: 6 months
Cut down the amount of time you spent on work or other activities , Accomplished less than you would like
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health, Subjective, run by University of Jordan at 2 sites in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
leg pain (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.