The PARTUM Trial: Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity

NCT06494878 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: REB24-0317
• Study Type: interventional
• Target: 8,805
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Venous Thromboembolism; Postpartum Period; Aspirin; Low Molecular Weight Heparin

Keywords

deep vein thrombosis; pulmonary embolism; postpartum; pregnancy; thrombophilia; cesarean delivery; preeclampsia; small-for-gestational age infant; postpartum hemorrhage; postpartum infection

Outcome Measures

Primary Outcomes (1)

• Symptomatic VTE

  Proximal lower or upper extremity DVT, PE involving segmental or higher arteries or multiple subsegmental arteries, and unusual site \[non-limb\] venous thromboembolism

  6 weeks

Secondary Outcomes (11)

• Late symptomatic VTE

  90 days

• Superficial vein thrombosis

  At 6 weeks and at 90 days

• Distal deep vein thrombosis

  At 6 weeks and at 90 days

• Single subsegmental pulmonary embolism (SSPE)

  At 6 weeks and at 90 days

• Major bleeding

  At 6 weeks and at 90 days

Study Arms (2)

Aspirin

EXPERIMENTAL

Low-dose aspirin (75-100 mg) once daily for 6 weeks.

Drug: Aspirin

Low-molecular-weight heparin

ACTIVE COMPARATOR

Site-specific low-molecular-weight heparin regimen as prescribed by the treating physician.

Drug: Low-molecular-weight heparin

Interventions

Aspirin DRUG

75-100 mg taken once daily by mouth.

Aspirin

Low-molecular-weight heparin DRUG

Low-molecular-weight heparin injections daily as prescribed by the treating physician.

Also known as: Dalteparin, Enoxaparin, Nadroparin, Tinzaparin

Low-molecular-weight heparin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• More than 48 hours since delivery at the time of randomization
• Received more than 1 dose of LMWH since delivery
• Need for postpartum LMWH prophylaxis or systemic anticoagulation as judged by their physician and/or local investigator. May include but is not limited to:
• Documented history of provoked or unprovoked VTE
• Mechanical heart valve(s)
• Known antiphospholipid syndrome (APS)
• Known high-risk inherited thrombophilia i) Antithrombin deficiency, or ii) Homozygous factor V Leiden, or iii) Homozygous prothrombin gene mutation, or iv) More than 1 thrombophilia: any combination of 2 or more: factor V Leiden, prothrombin gene mutation, protein C deficiency, protein S deficiency
• Need for postpartum ASA as judged by their physician and/or local investigator. May include but is not limited to:
• Documented history of myocardial infarction
• Documented history of ischemic stroke or transient ischemic attack (TIA)
• Active bleeding, excluding normal vaginal bleeding, at the time of randomization
• Known medical condition as judged by their physician and/or local investigator to be a contraindication to ASA or LMWH including known ASA or LMWH allergy
• \<18 years of age
• Unable or declined consent

Sponsors & Collaborators

• University of Calgary: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (3)

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

The Ottawa Hospital - General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1Z5, Canada

Location

MeSH Terms

Conditions

Venous Thromboembolism; Venous Thrombosis; Pulmonary Embolism; Thrombophilia; Pre-Eclampsia; Postpartum Hemorrhage

Interventions

Aspirin; Heparin, Low-Molecular-Weight; Dalteparin; Enoxaparin; Nadroparin; Tinzaparin

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis; Lung Diseases; Respiratory Tract Diseases; Embolism; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Leslie Skeith, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

• Marc Rodger, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leslie Skeith, MD

CONTACT

403-944-5246; laskeith@ucalgary.ca

Jill Baxter, BSc

CONTACT

403-220-7103; jbaxter@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: July 10, 2024
• Study Start: April 1, 2025
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

CA (3)