PRospective Evaluation of Peripartum Anticoagulation ManaGement for ThrOmboembolism

Last updated: February 26, 2025
Sponsor: University of Calgary
Overall Status: Active - Recruiting

Phase

N/A

Condition

Thromboembolism

Venous Thromboembolism

Blood Clots

Treatment

N/A

Clinical Study ID

NCT05756244
REB21-0795
  • Ages 18-60
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years of age or older

  • Requires anticoagulation during the antepartum period of pregnancy for a VTEindication, including at least one of:

  1. Objectively confirmed VTE (DVT, superficial vein thrombosis [SVT], PE orunusual 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

Exclusion Criteria:

  • Anticoagulation for a non-VTE indication, including prosthetic heart valves, atrialfibrillation, prevention of placenta-mediated pregnancy complications, or preventionof recurrent pregnancy loss (participants can be included with a diagnosis ofantiphospholipid syndrome (APS) with or without thrombotic events)

  • Unable to provide or declined consent.

  • Home or birthing centre planned delivery.

Study Design

Total Participants: 825
Study Start date:
April 04, 2023
Estimated Completion Date:
December 31, 2029

Study 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.

Connect with a study center

  • Foothills Medical Centre

    Calgary, Alberta T2N 2T9
    Canada

    Active - Recruiting

  • BC Women's Hospital and Health Centre

    Vancouver, British Columbia V6H 3N1
    Canada

    Active - Recruiting

  • St. Boniface Hospital

    Winnipeg, Manitoba R2H 2A6
    Canada

    Active - Recruiting

  • Mount Sinai Hospital

    Toronto, Ontario M5G 1X5
    Canada

    Active - Recruiting

  • Aarhus University Hospital

    Aarhus, 8200
    Denmark

    Active - Recruiting

  • Le Centre Hospitalier Universitaire of Saint-Etienne

    Saint-Etienne,
    France

    Active - Recruiting

  • Duke University Hospital

    Durham, North Carolina 27710
    United States

    Active - Recruiting

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