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Heparin for Pregnant Women With Thrombophilia

NCT ID: NCT01019655

Last Updated: 2009-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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Pregnancy and Thrombophilia

Keywords

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thrombophilia pregnancy heparin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Nadroparin calcium

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

Group Type EXPERIMENTAL

Nadroparin calcium

Intervention Type DRUG

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

Control

No intervention other than usual care at the study site

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nadroparin calcium

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

Intervention Type DRUG

Other Intervention Names

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Fraxiparin; code number EU:1-21067

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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University of Vienna

Principal Investigators

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Clemens B Tempfer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Vienna

Locations

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Department of Obstetrics and Gynecology

Vienna, Vienna, Austria

Site Status

Countries

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Austria

Central Contacts

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Clemens B Tempfer, MD

Role: CONTACT

Phone: +43 1 40400

Email: [email protected]

Facility Contacts

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Stephan Polterauer, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 33779986 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22449204 (View on PubMed)

Other Identifiers

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tempfer2.0

Identifier Type: -

Identifier Source: org_study_id