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
  Purpose

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.


Condition Intervention Phase
Pregnancy and Thrombophilia
Drug: Nadroparin calcium
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Low Molecular Weight Heparin for Pregnant Women With Thrombophilia: a Prospective, Randomized, Open Trial

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • composite endpoint: pregnancy-associated thrombosis/thromboembolism, miscarriage, preeclampsia, intrauterine growth retardation [ Time Frame: 10.5 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: January 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nadroparin calcium
nadroparin calcium (fraxiparin®) 0.3 mL daily during pregnancy and six weeks post partum
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
No Intervention: Control
No intervention other than usual care at the study site

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01019655

Contacts
Contact: Clemens B Tempfer, MD +43 1 40400 ext 2915 clemens.tempfer@meduniwien.ac.at

Locations
Austria
Department of Obstetrics and Gynecology Not yet recruiting
Vienna, Austria, A-1090
Contact: Stephan Polterauer, MD    +43 1 40400 ext 2962    stephan.polterauer@meduniwien.ac.at   
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Clemens B Tempfer, MD University of Vienna
  More Information

No publications provided by Medical University of Vienna

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Clemens Tempfer, MD, University of Vienna
ClinicalTrials.gov Identifier: NCT01019655     History of Changes
Other Study ID Numbers: tempfer2.0
Study First Received: November 24, 2009
Last Updated: November 24, 2009
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
thrombophilia
pregnancy
heparin

Additional relevant MeSH terms:
Thrombophilia
Hematologic Diseases
Calcium, Dietary
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Nadroparin
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Therapeutic Uses
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 22, 2014