Venous Thromboembolism in Pregnancy Study (VIP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2009 by Oslo University Hospital
Sponsor:
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00856076
First received: March 4, 2009
Last updated: October 17, 2011
Last verified: March 2009
  Purpose

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
Venous Thromboembolism
Intrauterine Fetal Death

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Venous Thromboembolism and Intrauterine Fetal Death in Pregnancy - Epidemiology and Pathogenic Mechanisms

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Biospecimen Retention:   Samples With DNA

Serum, EDTA and citrated plasma, whole blood and processed DNA


Estimated Enrollment: 1200
Study Start Date: January 2005
Estimated Study Completion Date: December 2023
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00856076

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

Locations
Norway
Oslo University Hospital (formerly Ullevaal University Hospital) Active, not recruiting
Oslo, Norway, N-0424
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         
Sponsors and Collaborators
Oslo University Hospital
Investigators
Study Director: Per Morten Sandset, MD, PhD Oslo University Hospital Ullevål and University of Oslo
  More Information

Publications:
Additional 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
Study First Received: March 4, 2009
Last Updated: October 17, 2011
Health Authority: Norway: Data Protection Authority
Norway: Directorate of Health

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

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

ClinicalTrials.gov processed this record on October 20, 2014