Heparin for Pregnant Women With Thrombophilia
Low Molecular Weight Heparin for Pregnant Women With Thrombophilia: a Prospective, Randomized, Open Trial
1 other identifier
interventional
300
1 country
1
Brief Summary
The purpose of this study is to investigate whether heparin is an effective treatment in pregnant women at risk for thrombosis and other pregnancy-associated complications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2010
Typical duration for phase_3
1 active site
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
First Submitted
Initial submission to the registry
November 24, 2009
CompletedFirst Posted
Study publicly available on registry
November 25, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedNovember 25, 2009
November 1, 2009
2 years
November 24, 2009
November 24, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
composite endpoint: pregnancy-associated thrombosis/thromboembolism, miscarriage, preeclampsia, intrauterine growth retardation
10.5 months
Study Arms (2)
Nadroparin calcium
EXPERIMENTALnadroparin calcium (fraxiparin®) 0.3 mL daily during pregnancy and six weeks post partum
Control
NO INTERVENTIONNo intervention other than usual care at the study site
Interventions
nadroparin calcium (fraxiparin®) 0.3 mL daily during pregnancy and six weeks post partum
Eligibility Criteria
You may qualify if:
- Pregnant women with a singleton pregnancy
- Age \>18 years
- Ability to understand informed consent form
You may not qualify if:
- Allergy/hypersensitivity for nadroparin calcium
- Heparin-associated thrombocytopenia
- Organ lesions at risk for bleeding such as acute stomach/bowel ulcers, cerebral hemorrhage, cerebral aneurysm
- uncontrolled hypertension
- Liver and/or renal dysfunction
- Known hematologic disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Obstetrics and Gynecology
Vienna, Vienna, A-1090, Austria
Related Publications (2)
Middleton P, Shepherd E, Gomersall JC. Venous thromboembolism prophylaxis for women at risk during pregnancy and the early postnatal period. Cochrane Database Syst Rev. 2021 Mar 29;3(3):CD001689. doi: 10.1002/14651858.CD001689.pub4.
PMID: 33779986DERIVEDBennett SA, Bagot CN, Arya R. Pregnancy loss and thrombophilia: the elusive link. Br J Haematol. 2012 Jun;157(5):529-42. doi: 10.1111/j.1365-2141.2012.09112.x. Epub 2012 Mar 26.
PMID: 22449204DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Clemens B Tempfer, MD
University of Vienna
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 24, 2009
First Posted
November 25, 2009
Study Start
January 1, 2010
Primary Completion
January 1, 2012
Study Completion
December 1, 2012
Last Updated
November 25, 2009
Record last verified: 2009-11