Venous ThromboembolismNCT01176305
Venous Thromboembolism in Pregnant and Puerperal Women in Denmark 1995-2005
An observational study of Venous Thromboembolism, run by Hillerod Hospital, Denmark.
Trial summary
The purpose of this study is to describe the incidence of thromboembolic events in relation to pregnancy and when in pregnancy and the puerperal period. Read more about this study
- Who is it for?
- Ages 15 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Venous Thromboembolism
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 15 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Danish Women 15 to 49 years old in the period January 1995 through December 2005, free of previous VTE and current use of oral contraceptives.
Who may be able to join
- Danish woman at 15 to 49 years old in the period January 1995 through December 2005.
- Free of previous VTE and current use of oral contraceptives.
Who cannot join
- Previous VTE or current use of oral contraceptives.
About this study
The purpose of this study is to describe the incidence of thromboembolic events in relation to pregnancy and when in pregnancy and the puerperal period.
Read the detailed description
Venous thromboembolism (VTE) still causes maternal death in the western world. The purpose of this study is to estimate the relative and absolute risk of VTE at different gestational ages in pregnant women compared to non-pregnant women.
All Danish Women 15 to 49 years old in the period January 1995 through December 2005, free of previous VTE and current use of oral contraceptives are included.Non-pregnant women are controls.
- Conditions
- Venous Thromboembolism
- Keywords
- Thromboembolic event
- Medical subject headings
- Venous Thromboembolism, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Danish Women 15 to 49 years old. | Free of previous VTE and current use of oral contraceptives. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute incidence of thromboembolic event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies 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
- Retrospective
Sponsor and investigators
- Lead sponsor
- Hillerod Hospital, Denmark
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176305
- Sponsor's protocol ID
- RAV1
- Status last verified
- Oct 2009
- First submitted
- 5 Aug 2010
- Last updated
- 6 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venous Thromboembolism in Pregnant and Puerperal Women in Denmark 1995-2005
- ClinicalTrials.gov ID
- NCT01176305
- Acronym / sponsor ID
- RAV1
- Conditions
- Venous Thromboembolism
- Keywords
- Thromboembolic event
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Hillerod Hospital, DenmarkUniversity, hospital or other
- First posted
- 6 Aug 2010 (estimated)
- 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.
The purpose of this study is to describe the incidence of thromboembolic events in relation to pregnancy and when in pregnancy and the puerperal period.
Detailed description
Venous thromboembolism (VTE) still causes maternal death in the western world. The purpose of this study is to estimate the relative and absolute risk of VTE at different gestational ages in pregnant women compared to non-pregnant women.
All Danish Women 15 to 49 years old in the period January 1995 through December 2005, free of previous VTE and current use of oral contraceptives are included.Non-pregnant women are controls.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Danish Women 15 to 49 years old. | – | –Free of previous VTE and current use of oral contraceptives. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Danish Women 15 to 49 years old in the period January 1995 through December 2005, free of previous VTE and current use of oral contraceptives.
Key inclusion criteria (2 listed)
- Danish woman at 15 to 49 years old in the period January 1995 through December 2005.
- Free of previous VTE and current use of oral contraceptives.
Key exclusion criteria (1 listed)
- Previous VTE or current use of oral contraceptives.
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
Absolute incidence of thromboembolic event
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 6 Aug 2010.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism, run by Hillerod Hospital, Denmark.
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 2 inclusion and 1 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 6 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
Absolute incidence of thromboembolic event. 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 6 Aug 2010.