Heparin for Pregnant Women With Thrombophilia

Medical University of Vienna

Status and phase

Unknown

Phase 3

Conditions

Pregnancy and Thrombophilia

Treatments

Drug: Nadroparin calcium

Study type

Interventional

Funder types

Other

Identifiers

NCT01019655

tempfer2.0

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 estimated patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No 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