Evaluating anticoagulation management during pregnancy and postpartum
Official title: A Prospective Cohort Study Evaluating Peripartum Anticoagulation Management Among Pregnant Women With Venous Thromboembolism and Its Impact on Patient Outcomes
Run by University of Calgary · NCT05756244 · Data updated 2026-11-12
This study is trying to see how well anticoagulation management works for pregnant people using a specific medication to help prevent blood clots during and after pregnancy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | Women only |
| Enrollment | 825 (estimated) |
| Sponsor | University of Calgary Academic / other |
| Locations | 14 sites (Durham, North Carolina and 13 other locations) |
| Status | Recruiting |
| Started | April 4, 2023 |
| Main results expected | June 30, 2029 |
| Study ends | December 31, 2029 |
| Registry record updated | November 28, 2025 |
| Trial ID | NCT05756244 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include pregnant individuals aged 18 or older who require anticoagulation for a VTE indication during pregnancy.
✕Probably not a fit
Patients who are receiving anticoagulation for non-VTE indications or those planning home or birthing center deliveries may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study is an international multicenter prospective cohort that assesses anticoagulation management strategies around labor, delivery, and the postpartum period. It aims to collect quality data on postpartum bleeding events, venous thromboembolism (VTE) risk, delivery experiences, and healthcare utilization for individuals on low-molecular-weight heparin (LMWH) during pregnancy. By standardizing outcome definitions, the study seeks to improve understanding of the implications of anticoagulation management in pregnant individuals.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of anticoagulation management for pregnant individuals at risk of VTE.
How similar studies have gone: Other studies have explored anticoagulation management in pregnancy, but this specific approach is novel in its comprehensive evaluation of postpartum outcomes.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Duke University Hospital
Durham, North Carolina, United States Recruiting -
Foothills Medical Centre
Calgary, Alberta, Canada Recruiting -
Royal Alexandra Hospital
Edmonton, Alberta, Canada Recruiting -
BC Women's Hospital and Health Centre
Vancouver, British Columbia, Canada Recruiting -
St. Boniface Hospital
Winnipeg, Manitoba, Canada Recruiting -
McMaster University Medical Centre
Hamilton, Ontario, Canada Recruiting
Show 8 more locations
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The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada Recruiting -
Montfort Hospital
Ottawa, Ontario, Canada Recruiting -
Mount Sinai Hospital
Toronto, Ontario, Canada Recruiting -
CHU Sainte-Justine
Montreal, Quebec, Canada Recruiting -
The Sir Mortimer B. Davis Jewish General Hospital
Montreal, Quebec, Canada Recruiting -
Aarhus University Hospital
Aarhus, Denmark Recruiting -
Le Centre Hospitalier Universitaire of Saint-Etienne
Saint-Etienne, France Recruiting -
Hopitaux universitaires de Geneve
Geneva, Switzerland Recruiting
Study contacts
- Principal investigator: Leslie Skeith, MD — University of Calgary
- Study coordinator: Jill Baxter, BSc
- Email: jbaxter@ucalgary.ca
- Phone: 403-220-7103
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.