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NCT05756244Recruiting

PRospective Evaluation of Peripartum Anticoagulation ManaGement for ThrOmboembolism

University of Calgary

Start Date

4/4/2023

Completion Date

12/31/2029

Summary

The PREP and GO study is an international multicentre prospective cohort evaluating anticoagulation management strategies around labor and delivery and the postpartum period.

Detailed Description

The goal of this study is to provide quality data using standardized outcome definitions on postpartum bleeding events, venous thromboembolism (VTE) risk, delivery experience outcomes and health care utilization for intrapartum and postpartum anticoagulation management among pregnant individuals on low-molecular-weight heparin (LMWH) for prevention of treatment of VTE.

Eligibility Criteria

Age Range: 18 years to 60 years

Inclusion Criteria: * 18 years of age or older * Requires anticoagulation during the antepartum period of pregnancy for a VTE indication, including at least one of: 1. Objectively confirmed VTE (DVT, superficial vein thrombosis \[SVT\], PE or unusual site thrombosis) diagnosed during the current pregnancy; 2. Objectively confirmed VTE diagnosed in a prior pregnancy; 3. Objectively confirmed VTE diagnosed when not pregnant; 4. Inherited or acquired thrombophilia requiring anticoagulation. * Receiving any dose or type of LMWH during the antepartum period Exclusion Criteria: * Anticoagulation for a non-VTE indication, including prosthetic heart valves, atrial fibrillation, prevention of placenta-mediated pregnancy complications, or prevention of recurrent pregnancy loss (participants can be included with a diagnosis of antiphospholipid syndrome (APS) with or without thrombotic events) * Unable to provide or declined consent. * Home or birthing centre planned delivery.

Interested in This Trial?

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Conditions

Pregnancy RelatedVenous Thromboembolism

Locations

Duke University Hospital

Durham, North Carolina 27710

United States

Foothills Medical Centre

Calgary, Alberta T2N 2T9

Canada

Royal Alexandra Hospital

Edmonton, Alberta T5H 3V9

Canada

BC Women's Hospital and Health Centre

Vancouver, British Columbia V6H 3N1

Canada

St. Boniface Hospital

Winnipeg, Manitoba R2H 2A6

Canada

McMaster University Medical Centre

Hamilton, Ontario L8N 3Z5

Canada

The Ottawa Hospital - General Campus

Ottawa, Ontario K1H 8L6

Canada

Montfort Hospital

Ottawa, Ontario K1K 0T2

Canada

Mount Sinai Hospital

Toronto, Ontario M5G 1X5

Canada

CHU Sainte-Justine

Montreal, Quebec H3T 1C5

Canada

The Sir Mortimer B. Davis Jewish General Hospital

Montreal, Quebec H3T 1E2

Canada

Aarhus University Hospital

Aarhus, 8200

Denmark

Le Centre Hospitalier Universitaire of Saint-Etienne

Saint-Etienne,

France

Hopitaux universitaires de Geneve

Geneva, 1205

Switzerland