Clinical Trial: Venous Thromboembolism in Pregnancy Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Venous Thromboembolism and Intrauterine Fetal Death in Pregnancy - Epidemiology and Pathogenic Mechanisms

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.

Detailed Summary:

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
  Sponsor: Oslo University Hospital
  

  Current Primary Outcome:
  
  

  Original Primary Outcome:
  
  

  Current Secondary Outcome:
  
  

  Original Secondary Outcome:
  
  Information By: Oslo University Hospital
  

  Dates:
  Date Received: March 4, 2009
  Date Started: January 2005
  Date Completion: December 2023
  Last Updated: October 17, 2011
  Last Verified: March 2009