Venous Thromboembolism in Pregnancy Study (VIP)

October 17, 2011 updated by: Oslo University Hospital

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Norway
      • Oslo, Norway, N-0407
        • Recruiting
        • Oslo University Hospital Ullevaal (formerly Ullevaal University Hospital)
        • 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, Norway, N-0424
        • Active, not recruiting
        • Oslo University Hospital (formerly Ullevaal University Hospital)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Investigators

  • Study Director: Per Morten Sandset, MD, PhD, Oslo University Hospital Ullevål and University of Oslo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

December 1, 2010

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

March 4, 2009

First Submitted That Met QC Criteria

March 4, 2009

First Posted (Estimate)

March 5, 2009

Study Record Updates

Last Update Posted (Estimate)

October 18, 2011

Last Update Submitted That Met QC Criteria

October 17, 2011

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIP-study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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