PRospective Evaluation of Peripartum Anticoagulation ManaGement for ThrOmboembolism

NCT ID: NCT05756244

Last Updated: 2025-11-28

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

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Recruitment Status

RECRUITING

Total Enrollment

825 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-04

Study Completion Date

2029-12-31

Brief Summary

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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

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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.

Conditions

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Pregnancy Related Venous Thromboembolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leslie Skeith, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Isabelle Malhamé, MD

Role: PRINCIPAL_INVESTIGATOR

McGill University

Kinga Malinowski, MD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

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Duke University Hospital

Durham, North Carolina, United States

Site Status RECRUITING

Foothills Medical Centre

Calgary, Alberta, Canada

Site Status RECRUITING

Royal Alexandra Hospital

Edmonton, Alberta, Canada

Site Status RECRUITING

BC Women's Hospital and Health Centre

Vancouver, British Columbia, Canada

Site Status RECRUITING

St. Boniface Hospital

Winnipeg, Manitoba, Canada

Site Status RECRUITING

McMaster University Medical Centre

Hamilton, Ontario, Canada

Site Status RECRUITING

The Ottawa Hospital - General Campus

Ottawa, Ontario, Canada

Site Status RECRUITING

Montfort Hospital

Ottawa, Ontario, Canada

Site Status RECRUITING

Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

CHU Sainte-Justine

Montreal, Quebec, Canada

Site Status RECRUITING

The Sir Mortimer B. Davis Jewish General Hospital

Montreal, Quebec, Canada

Site Status RECRUITING

Aarhus University Hospital

Aarhus, , Denmark

Site Status RECRUITING

Le Centre Hospitalier Universitaire of Saint-Etienne

Saint-Etienne, , France

Site Status RECRUITING

Hopitaux universitaires de Geneve

Geneva, , Switzerland

Site Status RECRUITING

Countries

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United States Canada Denmark France Switzerland

Central Contacts

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Jill Baxter, BSc

Role: CONTACT

403-220-7103

Leslie Skeith, MD

Role: CONTACT

403-944-5246

Facility Contacts

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Danielle Lanpher

Role: primary

Emily McKibbon

Role: primary

403-220-7631

Leslie Skeith, MD

Role: backup

403-944-5246

Shauna Littlefair-Beamish, BScN

Role: primary

780-735-5420

Simran Singh

Role: primary

David Kent

Role: primary

204-237-2985

Jessica Murphy

Role: primary

905-525-9140 ext. 21334

Cecilia Germano

Role: primary

Christine-Nadia Compas

Role: primary

613-746-4621 ext. 6051

Natasha Milligan

Role: primary

Hasna Meddour

Role: primary

Stephanie Scala

Role: primary

514-340-8222 ext. 27015

Jens Fuglsang, MD

Role: primary

Gwendoline Dorel

Role: primary

Juanita Techer

Role: backup

Pauline Gosselin

Role: primary

Other Identifiers

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REB21-0795

Identifier Type: -

Identifier Source: org_study_id

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