NCT00856076

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 5, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
13 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

October 18, 2011

Status Verified

March 1, 2009

Enrollment Period

5.9 years

First QC Date

March 4, 2009

Last Update Submit

October 17, 2011

Conditions

Venous ThromboembolismIntrauterine Fetal Death

Keywords

Venous thromboembolismIntrauterine fetal deathRisk factorThrombophiliaVenous thromboembolism (in pregnancy)

Study Arms (10)

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.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Oslo University Hospital Ullevaal (formerly Ullevaal University Hospital)

Oslo, N-0407, Norway

RECRUITING

Oslo University Hospital (formerly Ullevaal University Hospital)

Oslo, N-0424, Norway

ACTIVE NOT RECRUITING

Related Publications (6)

  • Bergrem A, Jacobsen EM, Skjeldestad FE, Jacobsen AF, Skogstad M, Sandset PM. The association of antiphospholipid antibodies with pregnancy-related first time venous thrombosis--a population-based case-control study. Thromb Res. 2010 May;125(5):e222-7. doi: 10.1016/j.thromres.2009.12.006. Epub 2010 Jan 6.

    PMID: 20051285BACKGROUND

  • Jacobsen AF, Skjeldestad FE, Sandset PM. Incidence and risk patterns of venous thromboembolism in pregnancy and puerperium--a register-based case-control study. Am J Obstet Gynecol. 2008 Feb;198(2):233.e1-7. doi: 10.1016/j.ajog.2007.08.041. Epub 2007 Nov 12.

    PMID: 17997389RESULT

  • Jacobsen AF, Skjeldestad FE, Sandset PM. Ante- and postnatal risk factors of venous thrombosis: a hospital-based case-control study. J Thromb Haemost. 2008 Jun;6(6):905-12. doi: 10.1111/j.1538-7836.2008.02961.x. Epub 2008 Mar 21.

    PMID: 18363820RESULT

  • Gravensteen IK, Helgadottir LB, Jacobsen EM, Radestad I, Sandset PM, Ekeberg O. Women's experiences in relation to stillbirth and risk factors for long-term post-traumatic stress symptoms: a retrospective study. BMJ Open. 2013 Oct 22;3(10):e003323. doi: 10.1136/bmjopen-2013-003323.

    PMID: 24154514DERIVED

  • Gravensteen IK, Helgadottir LB, Jacobsen EM, Sandset PM, Ekeberg O. Long-term impact of intrauterine fetal death on quality of life and depression: a case-control study. BMC Pregnancy Childbirth. 2012 Jun 7;12:43. doi: 10.1186/1471-2393-12-43.

    PMID: 22676992DERIVED

  • Jacobsen AF, Dahm A, Bergrem A, Jacobsen EM, Sandset PM. Risk of venous thrombosis in pregnancy among carriers of the factor V Leiden and the prothrombin gene G20210A polymorphisms. J Thromb Haemost. 2010 Nov;8(11):2443-9. doi: 10.1111/j.1538-7836.2010.04038.x.

    PMID: 20735725DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Venous ThromboembolismStillbirthThrombophilia

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesFetal DeathPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDeathPathologic ProcessesPathological Conditions, Signs and SymptomsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Per Morten Sandset, MD, PhD

    Oslo University Hospital Ullevål and University of Oslo

    STUDY DIRECTOR

Central Study Contacts

Per-Morten Sandset, MD; PhD

CONTACT

+4722119247p.m.sandset@medisin.uio.no

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2009

First Posted

March 5, 2009

Study Start

January 1, 2005

Primary Completion

December 1, 2010

Study Completion

December 1, 2023

Last Updated

October 18, 2011

Record last verified: 2009-03

Locations

NO(2)