PRospective Evaluation of Peripartum Anticoagulation ManaGement for ThrOmboembolism

University of Calgary825 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

825

Conditions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (14)

Duke University Hospital

Durham, North Carolina, United States

RECRUITING

Foothills Medical Centre

Calgary, Alberta, Canada

Outcomes

Primary Outcomes

Incidence of MB and CRNMB

To estimate the combined incidence of major bleeding (MB) and clinically relevant non-major bleeding (CRNMB) for the six most common antepartum strategies.

Time frame: Delivery up to 6 weeks postpartum

Secondary Outcomes

Practice Patterns

To determine the practice patterns of intrapartum and postpartum anticoagulant management for pregnant individuals on LMWH for VTE indications across participating centres.

Time frame: Prior to delivery and following delivery

MB and CRNMB incidence in the immediate and 6 W postpartum period

To estimate the incidence of MB and CRNMB in the immediate postpartum period (within 24 hours) and up to 6 weeks postpartum for each antepartum strategy.

Time frame: Within 24 hours of delivery and up to 6 weeks postpartum

MB and CRNMB incidence up to 6 W postpartum related to anticoagulation resumption

To estimate the incidence of MB and CRNMB up to 6 weeks postpartum, based on the time and dose of postpartum anticoagulation resumption.

Time frame: 6 weeks postpartum

Incidence of VTE

To estimate the incidence of symptomatic objectively confirmed VTE up to 6 weeks postpartum for each antepartum strategy.

Time frame: Delivery to 6 weeks postpartum

Wound Hematoma

To estimate the incidence of wound hematoma complications up to 6 weeks postpartum for each antepartum strategy.

Time frame: Delivery to 6 weeks postpartum

Anti-Xa levels

Central Contacts

Jill Baxter, BSc

CONTACT

403-220-7103 jbaxter@ucalgary.ca

Leslie Skeith, MD

CONTACT

403-944-5246 laskeith@ucalgary.ca

Data from ClinicalTrials.gov

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