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

Completed · Phase 4

Conditions studied: Deep Venous Thrombosis, Pulmonary Embolism

In brief

This is a randomized-controlled open-label trial comparing two different doses of low-molecular-weight heparin (LMWH) in pregnant patients with a history of previous venous thromboembolism (VTE). Both doses are recommended doses in the 2012 guidelines of the American College of Chest Physicians (ACCP), but it is not known which dose is more efficacious in preventing recurrent venous thromboembolism in pregnancy. Patients enter the study and will be randomized as soon as a home test confirms pregnancy. LMWH will be administered until 6 weeks postpartum. Follow-up will continue until 3 months postpartum. Patients will be recruited by their treating physician, either an obstetrician or internist.

Key facts

Study ID

NCT01828697

Run by

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

People needed

1110

Starts

2013-04-24

Expected to finish

2021-10-31

Last updated by the study team

2022-05-26

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Age: 18 years or older, and;
• Pregnancy confirmed by urinary pregnancy test, and;
• Gestational age < 14 weeks, and;
• Previous objectively confirmed VTE, either unprovoked, in the presence of use of oral contraceptives or estrogen/progestagen use, or related to pregnancy or the postpartum period, or minor risk factors (e.g. long distance travel, minor trauma).

You may not qualify if…

• Previous VTE related to a major provoking risk factor (e.g. surgery, major trauma or plaster cast immobilisation in the 3 months prior to VTE) as the sole risk factor, or;
• Indication for treatment with therapeutic dose anticoagulant therapy (e.g. treatment of acute VTE; permanent use of therapeutic anticoagulants outside of pregnancy), or;
• Inability to provide informed consent, or;
• Any contraindication listed in the local labelling of LMWH.

Where it is running

• KU Leuven — Leuven, Belgium
• The Ottawa Hospital — Ottawa, Canada
• Aalborg University Hospital — Aalborg, Denmark
• Aarhus University Hospital — Aarhus, Denmark
• CHU de Besancon — Besançon, France
• CHU de Bordeaux — Bordeaux, France
• CHU de Brest — Brest, France
• CHU de Caen — Caen, France
• CHU de Clermont - Ferrand — Clermont-Ferrand, France
• APHP Louis Mourier — Colombes, France
• CHU de Grenoble — Grenoble, France
• CHU de Limoges — Limoges, France
• Hopiteaux de Marseille — Marseille, France
• Marseille St Joseph — Marseille, France
• CHU de Nancy — Nancy, France
• CHU de Nice — Nice, France
• CHU de Nîmes — Nîmes, France
• APHP Antoine Béclère — Paris, France
• APHP Port Royal — Paris, France
• CHU de Poitiers — Paris, France
• Centra Hospitalier de Roanne — Roanne, France
• La Réunion - Saint-Denis — Saint-Denis, France
• Hopital Nord, CHU de Saint Etienne — Saint-Etienne, France
• La Réunion deSt Pierre — Saint-Pierre, France
• Weill Cornell Medicine | NewYork-Presbyterian — New York, New York, United States

Full record on ClinicalTrials.gov

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