Pilot PARTUM Trial: Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity

NCT04153760 | Completed Early Phase 1 DMC

• 1 other identifier: REB19-1237
• Study Type: interventional
• Target: 257
• Locations: 4 countries
• Sites: 7

Brief Summary

The pilot PARTUM trial is a randomized, multicenter, placebo-controlled trial. Women who are at modest risk of VTE (as defined by the inclusion criteria) will be identified during pregnancy, labor and delivery and up to 48 hours postpartum. Eligible and consenting participants will be randomly assigned to one of two study arms: aspirin 81 mg daily or placebo daily for 6 weeks.

Conditions

Venous Thromboembolism; Postpartum Period; Aspirin

Keywords

deep vein thrombosis; pulmonary embolism; postpartum; pregnancy; thrombophilia; cesarean delivery; pre-eclampsia; postpartum hemorrhage

Outcome Measures

Primary Outcomes (1)

• Recruitment Rate

  Mean recruitment rate per center per month

  6 months

Secondary Outcomes (6)

• Consent Rate

  6 months

• Withdrawals/Loss to Follow-up

  9 months

• Study Drug Compliance

  6 months

• Time Required to Obtain Site Institutional Approvals

  24 months

• VTE Event Rate

  6 months

Study Arms (2)

Aspirin

ACTIVE COMPARATOR

Aspirin 81 mg daily for six weeks post-randomization (postpartum)

Drug: Aspirin 81 mg

Placebo

PLACEBO COMPARATOR

Placebo daily for six weeks post-randomization (postpartum)

Drug: Placebo

Interventions

Aspirin 81 mg DRUG

Aspirin 81 mg p.o. daily

Also known as: acetylsalicylic acid, ASA

Aspirin

Placebo DRUG

Placebo p.o. daily

Placebo

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 Criteria:
• Known inherited thrombophilia diagnosed prior to enrolment:
• i) Heterozygous factor V Leiden, OR ii) Heterozygous prothrombin gene variant, OR iii) Protein C deficiency, OR iv) Protein S deficiency
• Immobilization (90% of waking hours spent in bed) for ≥7 days anytime during the antepartum period
• TWO (or more) Second Order Criteria:
• Postpartum infection
• Postpartum hemorrhage (\>1000 mL of blood loss, regardless of delivery mode)
• Pre-pregnancy BMI ≥30 kg/m2
• Emergency or unplanned cesarean delivery
• Smoking ≥5 cigarettes/day before pregnancy
• Pre-eclampsia
• Current pregnancy ending in stillbirth (pregnancy loss \>20 weeks gestation)
• Small-for-gestational-age infant (\<3rd percentile adjusted for gestational age and sex).
• Previous history of superficial vein thrombosis

You may not qualify if:

• More than 48 hours since delivery
• Received more than 2 doses of low-molecular-weight heparin (LMWH) since delivery
• Need for postpartum LMWH prophylaxis or systemic anticoagulation as judged by the local investigator. May include but is not limited to:
• Documented history of provoked or unprovoked VTE
• Mechanical heart valve(s)
• Known antiphospholipid syndrome
• Known high-risk inherited thrombophilia i) Antithrombin deficiency; ii) Homozygous factor V Leiden; iii) Homozygous prothrombin gene mutation; iv) Compound heterozygosity factor V Leiden and prothrombin gene mutation; v) More than one inherited thrombophilia
• Need for postpartum aspirin as judged by the local investigator. May include but is not limited to:
• Documented history of myocardial infarction
• Documented history of ischemic stroke or transient ischemic attack (TIA)
• Contraindication to aspirin including:
• History of known aspirin allergy
• Documented history of a gastrointestinal ulcer
• Known platelet count \<50 x 109/L at any time during the current pregnancy or postpartum
• Active bleeding at any site, excluding normal vaginal bleeding, at the time of randomization

Sponsors & Collaborators

• University of Calgary: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network: collaborator

Study Sites (7)

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

British Columbia Women's Hospital & Health Centre

Vancouver, British Columbia, V6H 3N1, Canada

Location

The Ottawa Hospital - General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1Z5, Canada

Location

Centre Hospitalier Universitaire de Saint-Etienne

Saint-Étienne-de-Montluc, Pays de la Loire Region, 42270, France

Location

Rotunda Hospital

Dublin, D01 P5W9, Ireland

Location

The Amsterdam Medical Centre

Amsterdam, North Holland, 1105, Netherlands

Location

Related Publications (3)

• Skeith L, Malinowski AK, El-Chaar D, Chan WS, Donnelly J, Chauleur C, Ganzevoort W, Wood S, Dubois S, McCarthy C, Buchmuller A, Wiegers H, Gibson PS, Ni Ainle F, Middeldorp S, Duffett L, Bates SM, Garven A, Baxter J, Lethebe BC, Rodger MA; Pilot PARTUM Group. Low-dose aspirin versus placebo in postpartum venous thromboembolism: a multi-national, pilot, randomised, placebo-controlled trial. Lancet Haematol. 2025 Feb;12(2):e109-e119. doi: 10.1016/S2352-3026(24)00338-7. Epub 2025 Jan 16.

  PMID: 39827892 DERIVED

• Blondon M, Claver M, Celetta E, Righini M, de Tejada BM. Preventing Postpartum Venous Thromboembolism With Low-Molecular-Weight Heparin: The PP-HEP Pilot Randomised Controlled Trial. BJOG. 2025 Jan;132(1):35-43. doi: 10.1111/1471-0528.17943. Epub 2024 Sep 5.

  PMID: 39238110 DERIVED

• Middleton P, Shepherd E, Gomersall JC. Venous thromboembolism prophylaxis for women at risk during pregnancy and the early postnatal period. Cochrane Database Syst Rev. 2021 Mar 29;3(3):CD001689. doi: 10.1002/14651858.CD001689.pub4.

  PMID: 33779986 DERIVED

MeSH Terms

Conditions

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

Interventions

Aspirin

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

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 6, 2019
• Study Start: October 7, 2020
• Primary Completion: September 5, 2023
• Study Completion: September 5, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); CA (4); NL (1); IE (1)