RECRUITING

PRospective Evaluation of Peripartum Anticoagulation ManaGement for ThrOmboembolism

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Prospective Cohort Study Evaluating Peripartum Anticoagulation Management Among Pregnant Women with Venous Thromboembolism and Its Impact on Patient Outcomes

Quick Facts

Study Start:2023-04-04
Study Completion:2029-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05756244

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years of age or older
  2. * Requires anticoagulation during the antepartum period of pregnancy for a VTE indication, including at least one of:
  3. 1. Objectively confirmed VTE (DVT, superficial vein thrombosis \[SVT\], PE or unusual site thrombosis) diagnosed during the current pregnancy;
  4. 2. Objectively confirmed VTE diagnosed in a prior pregnancy;
  5. 3. Objectively confirmed VTE diagnosed when not pregnant;
  6. 4. Inherited or acquired thrombophilia requiring anticoagulation.
  7. * Receiving any dose or type of LMWH during the antepartum period
  1. * 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)
  2. * Unable to provide or declined consent.
  3. * Home or birthing centre planned delivery.

Contacts and Locations

Study Contact

Jill Baxter, BSc
CONTACT
403-220-7103
jbaxter@ucalgary.ca
Leslie Skeith, MD
CONTACT
403-944-5246
laskeith@ucalgary.ca

Principal Investigator

Leslie Skeith, MD
PRINCIPAL_INVESTIGATOR
University of Calgary
Isabelle Malhamé, MD
PRINCIPAL_INVESTIGATOR
McGill University
Kinga Malinowski, MD
PRINCIPAL_INVESTIGATOR
University of Toronto

Study Locations (Sites)

Duke University Hospital
Durham, North Carolina, 27710
United States

Collaborators and Investigators

Sponsor: University of Calgary

  • Leslie Skeith, MD, PRINCIPAL_INVESTIGATOR, University of Calgary
  • Isabelle Malhamé, MD, PRINCIPAL_INVESTIGATOR, McGill University
  • Kinga Malinowski, MD, PRINCIPAL_INVESTIGATOR, University of Toronto

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-04
Study Completion Date2029-12-31

Study Record Updates

Study Start Date2023-04-04
Study Completion Date2029-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Pregnancy Related
  • Venous Thromboembolism