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Venous Thromboembolism in Pregnancy Study (VIP)

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ClinicalTrials.gov Identifier: NCT00856076
Recruitment Status : Recruiting
First Posted : March 5, 2009
Last Update Posted : October 18, 2011
Sponsor:
Information provided by (Responsible Party):
Oslo University Hospital

Brief 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.

Condition or disease
Venous Thromboembolism Intrauterine Fetal Death

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Venous Thromboembolism and Intrauterine Fetal Death in Pregnancy - Epidemiology and Pathogenic Mechanisms
Study Start Date : January 2005
Primary Completion Date : December 2010
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stillbirth
U.S. FDA Resources

Group/Cohort
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.



Biospecimen Retention:   Samples With DNA
Serum, EDTA and citrated plasma, whole blood and processed DNA


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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

Criteria

Inclusion Criteria:

  • women with first-time objectively verified venous thromboembolism in pregnancy.
  • women with history of intrauterine fetal death.

Exclusion Criteria:

  • recurrent venous thromboembolism in pregnancy.
  • non-validated venous thromboembolism in pregnancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00856076


Contacts
Contact: Per-Morten Sandset, MD; PhD +4722119247 p.m.sandset@medisin.uio.no

Locations
Norway
Oslo University Hospital Ullevaal (formerly Ullevaal University Hospital) Recruiting
Oslo, Norway, N-0407
Sub-Investigator: Anne F Jacobsen, MD, PhD         
Sub-Investigator: Linda B Helgadottir, MD         
Sub-Investigator: Astrid Bergrem, MD         
Sub-Investigator: Finn Egil Skjeldestad, MD, PhD         
Sub-Investigator: Eva-Marie Jacobsen, MD, PhD         
Sub-Investigator: Hilde S Wik, MD         
Sub-Investigator: Leiv Sandvik, PhD         
Sub-Investigator: Ida Kathrine Gravensten, Med Student         
Sub-Investigator: Anders Dahm, MD, PhD         
Oslo University Hospital (formerly Ullevaal University Hospital) Active, not recruiting
Oslo, Norway, N-0424
Sponsors and Collaborators
Oslo University Hospital
Investigators
Study Director: Per Morten Sandset, MD, PhD Oslo University Hospital Ullevål and University of Oslo

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT00856076     History of Changes
Other Study ID Numbers: VIP-study
First Posted: March 5, 2009    Key Record Dates
Last Update Posted: October 18, 2011
Last Verified: March 2009

Keywords provided by Oslo University Hospital:
Venous thromboembolism
Intrauterine fetal death
Risk factor
Thrombophilia
Venous thromboembolism (in pregnancy)

Additional relevant MeSH terms:
Thromboembolism
Death
Venous Thromboembolism
Fetal Death
Stillbirth
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Pregnancy Complications