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Heparin for Pregnant Women With Thrombophilia

Primary Purpose

Pregnancy and Thrombophilia

Status
Unknown status
Phase
Phase 3
Locations
Austria
Study Type
Interventional
Intervention
Nadroparin calcium
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy and Thrombophilia focused on measuring thrombophilia, pregnancy, heparin

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Obstetrics and Gynecology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Nadroparin calcium

Control

Arm Description

nadroparin calcium (fraxiparin®) 0.3 mL daily during pregnancy and six weeks post partum

No intervention other than usual care at the study site

Outcomes

Primary Outcome Measures

composite endpoint: pregnancy-associated thrombosis/thromboembolism, miscarriage, preeclampsia, intrauterine growth retardation

Secondary Outcome Measures

Full Information

First Posted
November 24, 2009
Last Updated
November 24, 2009
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT01019655
Brief Title
Heparin for Pregnant Women With Thrombophilia
Official Title
Low Molecular Weight Heparin for Pregnant Women With Thrombophilia: a Prospective, Randomized, Open Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy and Thrombophilia
Keywords
thrombophilia, pregnancy, heparin

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nadroparin calcium
Arm Type
Experimental
Arm Description
nadroparin calcium (fraxiparin®) 0.3 mL daily during pregnancy and six weeks post partum
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention other than usual care at the study site
Intervention Type
Drug
Intervention Name(s)
Nadroparin calcium
Other Intervention Name(s)
Fraxiparin; code number EU:1-21067
Intervention Description
nadroparin calcium (fraxiparin®) 0.3 mL daily during pregnancy and six weeks post partum
Primary Outcome Measure Information:
Title
composite endpoint: pregnancy-associated thrombosis/thromboembolism, miscarriage, preeclampsia, intrauterine growth retardation
Time Frame
10.5 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clemens B Tempfer, MD
Phone
+43 1 40400
Ext
2915
Email
clemens.tempfer@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clemens B Tempfer, MD
Organizational Affiliation
University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Obstetrics and Gynecology
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephan Polterauer, MD
Phone
+43 1 40400
Ext
2962
Email
stephan.polterauer@meduniwien.ac.at

12. IPD Sharing Statement

Citations:
PubMed Identifier
33779986
Citation
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.
Results Reference
derived
PubMed Identifier
22449204
Citation
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.
Results Reference
derived

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Heparin for Pregnant Women With Thrombophilia

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