NCT05756244

Brief Summary

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

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
825

participants targeted

Target at P75+ for all trials

Timeline
44mo left

Started Apr 2023

Longer than P75 for all trials

Geographic Reach
5 countries

14 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Apr 2023Dec 2029

First Submitted

Initial submission to the registry

February 21, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 6, 2023

Completed
29 days until next milestone

Study Start

First participant enrolled

April 4, 2023

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2029

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

November 28, 2025

Status Verified

February 1, 2025

Enrollment Period

6.2 years

First QC Date

February 21, 2023

Last Update Submit

November 21, 2025

Conditions

Pregnancy RelatedVenous Thromboembolism

Outcome Measures

Primary Outcomes (1)

  • 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.

    Delivery up to 6 weeks postpartum

Secondary Outcomes (9)

  • Practice Patterns

    Prior to delivery and following delivery

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

    Within 24 hours of delivery and up to 6 weeks postpartum

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

    6 weeks postpartum

  • Incidence of VTE

    Delivery to 6 weeks postpartum

  • Wound Hematoma

    Delivery to 6 weeks postpartum

  • +4 more secondary outcomes

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant individuals on anticoagulation for VTE-related indications

You may qualify if:

  • years of age or older
  • Requires anticoagulation during the antepartum period of pregnancy for a VTE indication, including at least one of:
  • Objectively confirmed VTE (DVT, superficial vein thrombosis \[SVT\], PE or unusual site thrombosis) diagnosed during the current pregnancy;
  • Objectively confirmed VTE diagnosed in a prior pregnancy;
  • Objectively confirmed VTE diagnosed when not pregnant;
  • Inherited or acquired thrombophilia requiring anticoagulation.
  • Receiving any dose or type of LMWH during the antepartum period

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Duke University Hospital

Durham, North Carolina, 27710, United States

RECRUITING

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

RECRUITING

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

RECRUITING

BC Women's Hospital and Health Centre

Vancouver, British Columbia, V6H 3N1, Canada

RECRUITING

St. Boniface Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

RECRUITING

McMaster University Medical Centre

Hamilton, Ontario, L8N 3Z5, Canada

RECRUITING

The Ottawa Hospital - General Campus

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Montfort Hospital

Ottawa, Ontario, K1K 0T2, Canada

RECRUITING

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

RECRUITING

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

RECRUITING

The Sir Mortimer B. Davis Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

Le Centre Hospitalier Universitaire of Saint-Etienne

Saint-Etienne, France

RECRUITING

Hopitaux universitaires de Geneve

Geneva, 1205, Switzerland

RECRUITING

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Leslie Skeith, MD

    University of Calgary

    PRINCIPAL INVESTIGATOR

  • Isabelle Malhamé, MD

    McGill University

    PRINCIPAL INVESTIGATOR

  • Kinga Malinowski, MD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jill Baxter, BSc

CONTACT

403-220-7103jbaxter@ucalgary.ca

Leslie Skeith, MD

CONTACT

403-944-5246laskeith@ucalgary.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2023

First Posted

March 6, 2023

Study Start

April 4, 2023

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

November 28, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

Please contact study PI for requests.

Locations

CH(1)DK(1)CA(10)US(1)FR(1)