Ignite Creation Date:
2024-05-05 @ 9:18 PM
Last Modification Date:
2024-10-26 @ 10:02 AM
Study NCT ID:
NCT00856076
Status:
UNKNOWN
Last Update Posted:
2011-10-18
First Post:
2009-03-04
Brief Title:
Venous Thromboembolism in Pregnancy Study
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Venous Thromboembolism and Intrauterine Fetal Death in Pregnancy - Epidemiology and Pathogenic Mechanisms
Status:
UNKNOWN
Status Verified Date:
2009-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIP
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 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 UllevålAker 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 DepartmentResearch Laboratory will handle this problem These patients will be offered additional information on thrombosis 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 UllevålAker 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 DepartmentResearch Laboratory will handle this problem These patients will be offered additional information on thrombosis in pregnancy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None