Recruiting

Anticoagulation Management

Sponsor:

University of Calgary

Code:

NCT05756244

Conditions

Pregnancy Related

Venous Thromboembolism

Eligibility Criteria

Sex: Female

Age: 18 - 60

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Pregnancy Related

Venous Thromboembolism

Study ID

NCT05756244

Start date

Apr 4, 2023

Status verified date

Feb, 2025

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Jun 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 60

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

825 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Incidence of MB and CRNMB [ Time Frame: Delivery up to 6 weeks postpartum ]

Central Contacts and Locations

Central contacts

Jill Baxter, BSc

403-220-7103jbaxter@ucalgary.ca

Leslie Skeith, MD

403-944-5246laskeith@ucalgary.ca

Locations

Duke University Hospital

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Danielle Lanpher

danielle.lanpher@duke.edu

Principal Investigator:

Jerome J Federspiel, MD

Foothills Medical Centre

Recruiting

Calgary, Alberta, Canada, T2N 2T9

Contacts

Emily McKibbon

403-220-7631emilyjoan.mckibbon@ucalgary.ca

Leslie Skeith, MD

403-944-5246laskeith@ucalgary.ca

Royal Alexandra Hospital

Recruiting

Edmonton, Alberta, Canada, T5H 3V9

Contacts

Shauna Littlefair-Beamish, BScN

780-735-5420shauna.littlefair@ahs.ca

Principal Investigator:

Jordan Marit, MD

BC Women's Hospital and Health Centre

Recruiting

Vancouver, British Columbia, Canada, V6H 3N1

Contacts

Simran Singh

simran.singh1@cw.bc.ca

Principal Investigator:

Wee Shian Chan, MD

St. Boniface Hospital

Recruiting

Winnipeg, Manitoba, Canada, R2H 2A6

Contacts

David Kent

204-237-2985dkent@sbgh.mb.ca

Principal Investigator:

Laura Chisick, MD

McMaster University Medical Centre

Recruiting

Hamilton, Ontario, Canada, L8N 3Z5

Contacts

Jessica Murphy

905-525-9140murphj11@mcmaster.ca

Principal Investigator:

Ann Kinga Malinowski, MD

The Ottawa Hospital - General Campus

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Cecilia Germano

cegermano@ohri.ca

Principal Investigator:

Lisa Duffett, MD

Montfort Hospital

Recruiting

Ottawa, Ontario, Canada, K1K 0T2

Contacts

Christine-Nadia Compas

613-746-4621christinencompas@montfort.on.ca

Principal Investigator:

Miriam Kimpton, MD

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G 1X5

Contacts

Natasha Milligan

Natasha.Milligan@sinaihealth.ca

Principal Investigator:

A. Kinga Malinowski, MD

CHU Sainte-Justine

Recruiting

Montreal, Quebec, Canada, H3T 1C5

Contacts

Hasna Meddour

hasna.meddour.hsj@ssss.gouv.qc.ca

Principal Investigator:

Evelyne Rey, MD

The Sir Mortimer B. Davis Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Contacts

Stephanie Scala

514-340-8222stephanie.scala@ladydavis.ca

Principal Investigator:

Camille Simard, MD

More Information

Sponsor

University of Calgary

Last update posted

Nov 28, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Calgary on 2025-11-28.