Venous Thromboembolism (VTE) Clinical Trials

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The PARTUM (Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity) Trial

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The goal of the PARTUM trial is to determine if taking low-dose aspirin daily for 6 weeks after delivery is similar (non-inferior) to usual care low-molecular-weight heparin injections to prevent venous thromboembolism (VTE: blood clots in the legs or lungs) for postpartum individuals with VTE risk factors.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• ONE (or more) First Order Criterion:

∙ Known inherited thrombophilia diagnosed prior to enrolment, regardless of family history of VTE:

∙ i. Heterozygous factor V Leiden, or ii. Heterozygous prothrombin gene variant, or iii. Protein C deficiency, or iv. Protein S deficiency, and/or

‣ Antepartum immobilization for ≥7 days. Immobilization is defined as bed rest with 90% of waking hours spent in bed at any time during the antepartum period AND/OR

• TWO (or more) Second Order Criteria:

⁃ Pre-pregnancy BMI ≥30 kg/m²

⁃ Smoking in the current pregnancy or within 3 months prior to pregnancy

⁃ Previous clinical history of superficial vein thrombosis

⁃ Preeclampsia

⁃ Current pregnancy ending in stillbirth (pregnancy loss \>20 weeks gestation)

⁃ Unplanned cesarean delivery (unplanned = not a scheduled cesarean delivery)

⁃ Small-for-gestational-age infant at time of delivery (\<3rd percentile adjusted for gestational age and sex)

⁃ Peripartum or postpartum infection (symptoms/signs of infection and documented fever and laboratory evidence of infection with positive blood cultures or an elevated white blood cell count based on local laboratory cutoffs)

⁃ Postpartum hemorrhage (≥1000 mL of blood loss, regardless of delivery mode)

Locations
Other Locations
Belgium
Association Hospitalière De Bruxelles Et De Schaerbeek - Centre Hospitalier Universitaire Brugmann
NOT_YET_RECRUITING
Brussels
Canada
Foothills Medical Centre
RECRUITING
Calgary
The Ottawa Hospital - General Campus
NOT_YET_RECRUITING
Ottawa
Denmark
Hvidovre Hospital
NOT_YET_RECRUITING
Hvidovre
France
CHU de Nancy
NOT_YET_RECRUITING
Nancy
APHP - Hôpital Port Royal
NOT_YET_RECRUITING
Paris
CHU de Saint-Etienne
NOT_YET_RECRUITING
Saint-etienne
CHU de Toulouse
NOT_YET_RECRUITING
Toulouse
Ireland
Rotunda Hospital, RCSI Department of Obstetrics and Gynaecology
NOT_YET_RECRUITING
Dublin
UCD Centre for Human Reproduction, The Coombe Hospital
NOT_YET_RECRUITING
Dublin
Netherlands
Amsterdam UMC
NOT_YET_RECRUITING
Amsterdam
Poland
Medical University of Warsaw
NOT_YET_RECRUITING
Warsaw
Contact Information
Primary
Leslie Skeith, MD
laskeith@ucalgary.ca
403-944-5246
Backup
Jill Baxter, BSc
jbaxter@ucalgary.ca
403-220-7103
Time Frame
Start Date: 2026-06-04
Estimated Completion Date: 2030-12
Participants
Target number of participants: 8805
Treatments
Experimental: Aspirin
Low-dose aspirin (75-100 mg) once daily for 6 weeks.
Active_comparator: Low-molecular-weight heparin
Site-specific low-molecular-weight heparin regimen as prescribed by the treating physician.
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR), European Clinical Research Infrastructure Network
Leads: University of Calgary

This content was sourced from clinicaltrials.gov

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