Evaluating anticoagulation management during pregnancy and postpartum

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

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
• Enrollment: 825 (estimated)
• Ages: 18 Years to 60 Years
• Sex: Female
• Sponsor: University of Calgary (Academic / other)
• Locations: 14 sites (Durham, North Carolina and 13 other locations)
• Trial ID: NCT05756244 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include pregnant individuals aged 18 or older who require anticoagulation for a VTE indication during pregnancy.

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.

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 performed: Other studies have explored anticoagulation management in pregnancy, but this specific approach is novel in its comprehensive evaluation of postpartum outcomes.

Eligibility 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 this trial is running

Durham, North Carolina and 13 other locations

• 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)
• 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

Conditions Pregnancy Related; Venous Thromboembolism