Venous ThromboembolismVIPNCT00856076
Venous Thromboembolism in Pregnancy Study
An observational study of Venous Thromboembolism and Intrauterine Fetal Death, run by Oslo University Hospital at 2 sites in Norway.
Trial summary
The purpose of this study is to investigate clinical, biochemical and genetic risk factors for venous thromboembolism in pregnancy and pregnancy related vascular complications, and the long-term outcome of such complications including implications for quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Venous Thromboembolism, Intrauterine Fetal Death
- How many people
- 1,200 participants
- Where
- 2 sitesNorway
- Study dates
- Jan 2005to Dec 2023
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cases: women with first-time validated venous thromboembolism in pregnancy or women who had experienced intrauterine fetal death, either all cases with validated data from medical records or cases meeting for blood sampling. Controls: women from the source population; either population based with data from the Norwegian Patient Registry or Norwegian Birth Registry, or hospital-based and randomly drawn from the source population and with validated data, or subset of the latter group meeting for blood sampling
Who may be able to join
- women with first-time objectively verified venous thromboembolism in pregnancy.
- women with history of intrauterine fetal death.
Who cannot join
- recurrent venous thromboembolism in pregnancy.
- non-validated venous thromboembolism in pregnancy.
Trial locations and contacts
2 sites in 1 country.
Norway2 sites, 1 recruiting
- Recruiting
Oslo University Hospital Ullevaal (formerly Ullevaal University Hospital)
Oslo, N-0407
Anne F Jacobsen, MD, PhD
Linda B Helgadottir, MD
- Active, not recruiting
Oslo University Hospital (formerly Ullevaal University Hospital)
Oslo, N-0424
About this study
Official title: Venous Thromboembolism and Intrauterine Fetal Death in Pregnancy - Epidemiology and Pathogenic Mechanisms
The purpose of this study is to investigate clinical, biochemical and genetic risk factors for venous thromboembolism in pregnancy and pregnancy related vascular complications, and the long-term outcome of such complications including implications for quality of life.
Read the detailed description
Background: Venous thromboembolism (VTE) in pregnancy is a serious, but rare condition. There is no epidemiological data on this patient group from Norway, and there is generally little literature on the immediate and long-term outcome after such pregnancies. Approximately 50% of the women with VTE in pregnancy have known thrombophilia. These women also carry a considerably increased risk for intrauterine fetal death (IUFD). In this project we want to identify new thrombophilias as risk factors for VTE and IUFD in pregnancy.
Aims:
Using a case-control design we will investigate the following issues:
- Risk factors for VTE in pregnancy and IUFD
- Association between thrombophilia, VTE, and other vascular pregnancy complications including IUFD
- Association between thrombophilia and IUFD
- Long term effects of VTE in pregnancy and IUFD on future health including quality of life
- Association between "single nucleotide polymorphisms" (SNP) in genes coding for specific coagulation-, fibrinolysis-, inflammatory, and other relevant proteins and their phenotypic expression
- Association between relevant phenotypes of coagulation, fibrinolysis, inflammation, and other relevant pathways and their risk of disease
- Association between the frequency of specific SNPs that codes for coagulation-, fibrinolysis-, inflammatory, and other relevant proteins and risk for VTE
Materials and Methods:
- 300 women with a history of VTE in their pregnancy and 150 women with IUFD will be identified by the Norwegian patient registry (NPR) and the Medical Birth Registry (MFR). The medical records of these patients will be checked. The epidemiological data will be collected with the help of questionnaires that the patients will fill out and blood samples will be collected. Blood samples will be analyzed with the aim to check for known coagulation factors and thrombophilias as well as new gene polymorphisms.
- 600 control women, from the maternity wards at Ullevål/Aker University Hospitals in the same time period, matched for age and ethnicity, will also answer questionnaires and donate blood samples. The medical records for these women will be checked.
Ethical problems: This study raises no new ethical problems. The study is based on voluntary participation from the invited and informed consent for all analyzes of biological test material. The study design, data procedures and storing of biological material, will use methods that assure the patients privacy at all levels.
The participants are invited to fill out a questionnaire concerning information of thrombosis in pregnancy and take one simple blood test. Women with symptoms of post thrombotic syndrome (PTS) will be offered a clinical examination of their lower extremities to verify the condition. The data will be de-identified and the individuals will not be able to be identify by other than those that have concession to the patient register established for this study.
Blood tests will be stored in a biobank at Ullevål University Hospital (UUS) established for this study, and will only be used for research related problems that have to do with this study.
Some patients could have a psychological reaction of the illness they experienced many years ago. The project leader or co-workers from the Hematology Department/Research Laboratory will handle this problem. These patients will be offered additional information on thrombosis in pregnancy.
- Conditions
- Venous Thromboembolism, Intrauterine Fetal Death
- Keywords
- Venous thromboembolism, Intrauterine fetal death, Risk factor, Thrombophilia, Venous thromboembolism (in pregnancy)
- Medical subject headings
- Venous Thromboembolism, Stillbirth, Thrombophilia
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 |
|---|---|---|
| VTE case group 1/2 | Women with first time venous thromboembolism in pregnancy. VTE data validated from medical records. | |
| VTE control group 1 | All pregnancies of source population - clinical data from the Norwegian Birth Registry and the Norwegian Patient Registry. | |
| VTE control group 2 | Randomly drawn from group 1 (using the Norwegian Birth Registry), but matched for time of delivery. Without history of venous thromboembolism, and with validated data from medical records. | |
| VTE case group 3 | Subjects from VTE case group 1/2 invited to meet for investigation, donation of biological material and to answer a questionnaire. | |
| VTE control group 3 | Subjects from VTE control group 2 invited to meet for investigation, donation of biological material and to answer a questionnaire. | |
| IUFD group 1 | Women who have experienced IUFD - data verified from medical records. | |
| IUFD group 2 | Subjects from IUFD group 2 invited to meet for investigation, donation of biological material and to answer a questionnaire. | |
| IUFD control group 1 | All pregnancies of source population - clinical data from the Norwegian Birth Registry and the Norwegian Patient Registry. | |
| IUFD control group 2 | Subjects from VTE control group 1/2 with validated data from medical records. | |
| IUFD control group 3 | Subjects from VTE control group 3 invited to answer a disease specific questionnaire for IUFD. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2009 (estimated)
- Study startJan 2005
- Primary completionDec 2010
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Per Morten Sandset, MD, PhD, Study director, Oslo University Hospital Ullevål and University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00856076
- Sponsor's protocol ID
- VIP-study
- Acronym
- VIP
- Status last verified
- Mar 2009
- First submitted
- 4 Mar 2009
- Last updated
- 18 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Bergrem A, Jacobsen EM, Skjeldestad FE, Jacobsen AF, Skogstad M, Sandset PM. The association of antiphospholipid antibodies with pregnancy-related first time venous thrombosis--a population-based case-control study. Thromb Res. 2010 May;125(5):e222-7. doi: 10.1016/j.thromres.2009.12.006. Epub 2010 Jan 6.
PubMed 20051285Jacobsen AF, Skjeldestad FE, Sandset PM. Incidence and risk patterns of venous thromboembolism in pregnancy and puerperium--a register-based case-control study. Am J Obstet Gynecol. 2008 Feb;198(2):233.e1-7. doi: 10.1016/j.ajog.2007.08.041. Epub 2007 Nov 12.
PubMed 17997389Jacobsen AF, Skjeldestad FE, Sandset PM. Ante- and postnatal risk factors of venous thrombosis: a hospital-based case-control study. J Thromb Haemost. 2008 Jun;6(6):905-12. doi: 10.1111/j.1538-7836.2008.02961.x. Epub 2008 Mar 21.
PubMed 18363820Gravensteen IK, Helgadottir LB, Jacobsen EM, Radestad I, Sandset PM, Ekeberg O. Women's experiences in relation to stillbirth and risk factors for long-term post-traumatic stress symptoms: a retrospective study. BMJ Open. 2013 Oct 22;3(10):e003323. doi: 10.1136/bmjopen-2013-003323.
PubMed 24154514Gravensteen IK, Helgadottir LB, Jacobsen EM, Sandset PM, Ekeberg O. Long-term impact of intrauterine fetal death on quality of life and depression: a case-control study. BMC Pregnancy Childbirth. 2012 Jun 7;12:43. doi: 10.1186/1471-2393-12-43.
PubMed 22676992Jacobsen AF, Dahm A, Bergrem A, Jacobsen EM, Sandset PM. Risk of venous thrombosis in pregnancy among carriers of the factor V Leiden and the prothrombin gene G20210A polymorphisms. J Thromb Haemost. 2010 Nov;8(11):2443-9. doi: 10.1111/j.1538-7836.2010.04038.x.
PubMed 20735725
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venous Thromboembolism and Intrauterine Fetal Death in Pregnancy - Epidemiology and Pathogenic Mechanisms
- ClinicalTrials.gov ID
- NCT00856076
- Acronym / sponsor ID
- VIP / VIP-study
- Conditions
- Venous Thromboembolism, Intrauterine Fetal Death
- Keywords
- Venous thromboembolism, Intrauterine fetal death, Risk factor, Thrombophilia, Venous thromboembolism (in pregnancy)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 5 Mar 2009 (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 investigate clinical, biochemical and genetic risk factors for venous thromboembolism in pregnancy and pregnancy related vascular complications, and the long-term outcome of such complications including implications for quality of life.
Detailed description
Background: Venous thromboembolism (VTE) in pregnancy is a serious, but rare condition. There is no epidemiological data on this patient group from Norway, and there is generally little literature on the immediate and long-term outcome after such pregnancies. Approximately 50% of the women with VTE in pregnancy have known thrombophilia. These women also carry a considerably increased risk for intrauterine fetal death (IUFD). In this project we want to identify new thrombophilias as risk factors for VTE and IUFD in pregnancy.
Aims:
Using a case-control design we will investigate the following issues:
- Risk factors for VTE in pregnancy and IUFD
- Association between thrombophilia, VTE, and other vascular pregnancy complications including IUFD
- Association between thrombophilia and IUFD
- Long term effects of VTE in pregnancy and IUFD on future health including quality of life
- Association between "single nucleotide polymorphisms" (SNP) in genes coding for specific coagulation-, fibrinolysis-, inflammatory, and other relevant proteins and their phenotypic expression
- Association between relevant phenotypes of coagulation, fibrinolysis, inflammation, and other relevant pathways and their risk of disease
- Association between the frequency of specific SNPs that codes for coagulation-, fibrinolysis-, inflammatory, and other relevant proteins and risk for VTE
Materials and Methods:
- 300 women with a history of VTE in their pregnancy and 150 women with IUFD will be identified by the Norwegian patient registry (NPR) and the Medical Birth Registry (MFR). The medical records of these patients will be checked. The epidemiological data will be collected with the help of questionnaires that the patients will fill out and blood samples will be collected. Blood samples will be analyzed with the aim to check for known coagulation factors and thrombophilias as well as new gene polymorphisms.
- 600 control women, from the maternity wards at Ullevål/Aker University Hospitals in the same time period, matched for age and ethnicity, will also answer questionnaires and donate blood samples. The medical records for these women will be checked.
Ethical problems: This study raises no new ethical problems. The study is based on voluntary participation from the invited and informed consent for all analyzes of biological test material. The study design, data procedures and storing of biological material, will use methods that assure the patients privacy at all levels.
The participants are invited to fill out a questionnaire concerning information of thrombosis in pregnancy and take one simple blood test. Women with symptoms of post thrombotic syndrome (PTS) will be offered a clinical examination of their lower extremities to verify the condition. The data will be de-identified and the individuals will not be able to be identify by other than those that have concession to the patient register established for this study.
Blood tests will be stored in a biobank at Ullevål University Hospital (UUS) established for this study, and will only be used for research related problems that have to do with this study.
Some patients could have a psychological reaction of the illness they experienced many years ago. The project leader or co-workers from the Hematology Department/Research Laboratory will handle this problem. These patients will be offered additional information on thrombosis in pregnancy.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| VTE case group 1/2 | – | –Women with first time venous thromboembolism in pregnancy. VTE data validated from medical records. |
| VTE control group 1 | – | –All pregnancies of source population - clinical data from the Norwegian Birth Registry and the Norwegian Patient Registry. |
| VTE control group 2 | – | –Randomly drawn from group 1 (using the Norwegian Birth Registry), but matched for time of delivery. Without history of venous thromboembolism, and with validated data from medical records. |
| VTE case group 3 | – | –Subjects from VTE case group 1/2 invited to meet for investigation, donation of biological material and to answer a questionnaire. |
| VTE control group 3 | – | –Subjects from VTE control group 2 invited to meet for investigation, donation of biological material and to answer a questionnaire. |
| IUFD group 1 | – | –Women who have experienced IUFD - data verified from medical records. |
| IUFD group 2 | – | –Subjects from IUFD group 2 invited to meet for investigation, donation of biological material and to answer a questionnaire. |
| IUFD control group 1 | – | –All pregnancies of source population - clinical data from the Norwegian Birth Registry and the Norwegian Patient Registry. |
| IUFD control group 2 | – | –Subjects from VTE control group 1/2 with validated data from medical records. |
| IUFD control group 3 | – | –Subjects from VTE control group 3 invited to answer a disease specific questionnaire for IUFD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cases: women with first-time validated venous thromboembolism in pregnancy or women who had experienced intrauterine fetal death, either all cases with validated data from medical records or cases meeting for blood sampling. Controls: women from the source population; either population based with data from the Norwegian Patient Registry or Norwegian Birth Registry, or hospital-based and randomly drawn from the source population and with validated data, or subset of the latter group meeting for blood sampling
Key inclusion criteria (2 listed)
- women with first-time objectively verified venous thromboembolism in pregnancy.
- women with history of intrauterine fetal death.
Key exclusion criteria (2 listed)
- recurrent venous thromboembolism in pregnancy.
- non-validated venous thromboembolism in pregnancy.
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2011.
- Background: PubMed 20051285Bergrem A, Jacobsen EM, Skjeldestad FE, Jacobsen AF, Skogstad M, Sandset PM. The association of antiphospholipid antibodies with pregnancy-related first time venous thrombosis--a population-based case-control study. Thromb Res. 2010 May;125(5):e222-7. doi: 10.1016/j.thromres.2009.12.006. Epub 2010 Jan 6.
- Results publication: PubMed 17997389Jacobsen AF, Skjeldestad FE, Sandset PM. Incidence and risk patterns of venous thromboembolism in pregnancy and puerperium--a register-based case-control study. Am J Obstet Gynecol. 2008 Feb;198(2):233.e1-7. doi: 10.1016/j.ajog.2007.08.041. Epub 2007 Nov 12.
- Results publication: PubMed 18363820Jacobsen AF, Skjeldestad FE, Sandset PM. Ante- and postnatal risk factors of venous thrombosis: a hospital-based case-control study. J Thromb Haemost. 2008 Jun;6(6):905-12. doi: 10.1111/j.1538-7836.2008.02961.x. Epub 2008 Mar 21.
- Derived from this study: PubMed 24154514Gravensteen IK, Helgadottir LB, Jacobsen EM, Radestad I, Sandset PM, Ekeberg O. Women's experiences in relation to stillbirth and risk factors for long-term post-traumatic stress symptoms: a retrospective study. BMJ Open. 2013 Oct 22;3(10):e003323. doi: 10.1136/bmjopen-2013-003323.
- Derived from this study: PubMed 22676992Gravensteen IK, Helgadottir LB, Jacobsen EM, Sandset PM, Ekeberg O. Long-term impact of intrauterine fetal death on quality of life and depression: a case-control study. BMC Pregnancy Childbirth. 2012 Jun 7;12:43. doi: 10.1186/1471-2393-12-43.
- Derived from this study: PubMed 20735725Jacobsen AF, Dahm A, Bergrem A, Jacobsen EM, Sandset PM. Risk of venous thrombosis in pregnancy among carriers of the factor V Leiden and the prothrombin gene G20210A polymorphisms. J Thromb Haemost. 2010 Nov;8(11):2443-9. doi: 10.1111/j.1538-7836.2010.04038.x.
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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.
Per Morten Sandset, MD, PhD study director
Oslo University Hospital Ullevål and University of Oslo
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 Venous Thromboembolism and Intrauterine Fetal Death, run by Oslo University Hospital at 2 sites in Norway.
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 2 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: status not confirmed, as of the sponsor's last update on 18 Oct 2011. 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 Norway. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Per-Morten Sandset, MD; PhD (+4722119247, p.m.sandset@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00856076, which also lists 6 linked publications.
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 Oct 2011.