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Heparin for Pregnant Women With Thrombophilia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Medical University of Vienna.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01019655
First received: November 24, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted

November 24, 2009
November 24, 2009
January 2010
January 2012   (final data collection date for primary outcome measure)
composite endpoint: pregnancy-associated thrombosis/thromboembolism, miscarriage, preeclampsia, intrauterine growth retardation [ Time Frame: 10.5 months ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Heparin for Pregnant Women With Thrombophilia
Low Molecular Weight Heparin for Pregnant Women With Thrombophilia: a Prospective, Randomized, Open Trial

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.

Women with thrombophilia, i.e. carriage of a factor V leiden mutation, a factor II prothrombin G20210A mutation or a reduced amount of antithrombin III, protein C or protein S, are at elevated risk for thrombosis and related sequelae. Specifically, pregnant women with thrombophilia are at risk for pregnancy-associated thrombosis, pregnancy-associated thromboembolism as well as early miscarriage (until 20 weeks gestation) late miscarriage (after 20 weeks gestation), preeclampsia, and intrauterine growth retardation <10th percentile. Uncontrolled retrospective and prospective studies indicate that a therapy with unfractionated heparin or low molecular weight heparin in pregnancy significantly reduces these pregnancy complications and improves maternal and fetal outcome. The use of low molecular weight heparin in pregnancy is safe with complication rates between 1% and 3%, mainly thrombocytopenia and bleeding complications. Randomized trials to adequately assess the safety and efficacy of heparin in pregnant women with thrombophilia are not available to date. Thus, we intend to randomize pregnant women with thrombophilia during weeks of gestation 11 to 14 into a therapy with nadroparin calcium (fraxiparin®) 0.3 mL daily during pregnancy and six weeks post partum and usual care. The primary end point of this study is a composite endpoint of pregnancy-associated thrombosis, pregnancy-associated thromboembolism, early miscarriage (until 20 weeks gestation) late miscarriage (after 20 weeks gestation), preeclampsia, and intrauterine growth retardation <10th percentile. We hypothesize that a prophylactic therapy with nadroparin calcium will significantly reduce pregnancy complications in pregnant women with thrombophilia.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Pregnancy and Thrombophilia
Drug: Nadroparin calcium
nadroparin calcium (fraxiparin®) 0.3 mL daily during pregnancy and six weeks post partum
Other Name: Fraxiparin; code number EU:1-21067
  • Experimental: Nadroparin calcium
    nadroparin calcium (fraxiparin®) 0.3 mL daily during pregnancy and six weeks post partum
    Intervention: Drug: Nadroparin calcium
  • No Intervention: Control
    No intervention other than usual care at the study site
Bennett 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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
300
December 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pregnant women with a singleton pregnancy
  • Age >18 years
  • Ability to understand informed consent form

Exclusion Criteria:

  • 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
Female
18 Years to 50 Years
No
Contact: Clemens B Tempfer, MD +43 1 40400 ext 2915 clemens.tempfer@meduniwien.ac.at
Austria
 
NCT01019655
tempfer2.0
No
Clemens Tempfer, MD, University of Vienna
Medical University of Vienna
Not Provided
Principal Investigator: Clemens B Tempfer, MD University of Vienna
Medical University of Vienna
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP