Heparin for Pregnant Women With Thrombophilia

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

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

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Short-term Low-dose Low-molecular-weight Heparin to Prevent Postpartum Thrombosis

NCT07140211

Venous Thromboembolism (VTE) Postpartum

NOT_YET_RECRUITING PHASE3

Comparison of Low and Intermediate Dose Low-molecular-weight Heparin to Prevent Recurrent Venous Thromboembolism in Pregnancy

NCT01828697

Deep Venous Thrombosis Pulmonary Embolism

COMPLETED PHASE4

Dose Adjusting Enoxaparin Thromboprophylaxis Dosage According to Anti-factor Xa Plasma Levels Improve Pregnancy Outcome

NCT01068795

Fetal Demise Fetal Growth Restriction Preeclampsia +2 more

COMPLETED NA

Study on Antithrombotic Prevention in Thrombophilia and Pregnancy Loss

NCT02385461

Pregnancy Complications

UNKNOWN

Need for Antepartum Thromboprophylaxis in Pregnant Women With One Prior Episode of Venous Thromboembolism (VTE)

NCT01357941

Venous Thromboembolism Deep Vein Thrombosis Pulmonary Embolism

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnancy and Thrombophilia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nadroparin calcium

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Fraxiparin; code number EU:1-21067

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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