Pilot PARTUM Trial: Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity

NCT ID: NCT04153760

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 257 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-07
• Study Completion Date: 2023-09-05

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.

Detailed Description

The purpose of the pilot PARTUM trial is to determine whether it is feasible to conduct a larger randomized controlled trial to determine whether low-dose aspirin is efficacious and safe at preventing postpartum venous thromboembolism (VTE) in women at increased risk of VTE, compared to placebo.

Given the large sample size needed to adequately power a large multicenter trial that assesses the efficacy of aspirin 81 mg versus placebo, the investigators first need to determine if it is possible to recruit enough women. If the pilot trial is successful and there are no major changes to the study design, then the secondary clinical outcomes collected in the pilot trial will be used in the analysis of the full multicenter trial.

Conditions

Venous Thromboembolism; Postpartum Period; Aspirin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Aspirin

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

Group Type: ACTIVE_COMPARATOR

Aspirin 81 mg

Intervention Type: DRUG

Aspirin 81 mg p.o. daily

Placebo

Placebo daily for six weeks post-randomization (postpartum)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo p.o. daily

Interventions

Aspirin 81 mg

Aspirin 81 mg p.o. daily

Intervention Type: DRUG

Placebo

Placebo p.o. daily

Intervention Type: DRUG

Other Intervention Names

acetylsalicylic acid; ASA

Eligibility Criteria

Inclusion Criteria

ONE (or more) First Order Criteria:

1. 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

2. Immobilization (90% of waking hours spent in bed) for ≥7 days anytime during the antepartum period

TWO (or more) Second Order Criteria:

1. Postpartum infection

2. Postpartum hemorrhage (>1000 mL of blood loss, regardless of delivery mode)

3. Pre-pregnancy BMI ≥30 kg/m2

4. Emergency or unplanned cesarean delivery

5. Smoking ≥5 cigarettes/day before pregnancy

6. Pre-eclampsia

7. Current pregnancy ending in stillbirth (pregnancy loss >20 weeks gestation)

8. Small-for-gestational-age infant (<3rd percentile adjusted for gestational age and sex).

9. Previous history of superficial vein thrombosis

Exclusion Criteria

1. More than 48 hours since delivery

2. Received more than 2 doses of low-molecular-weight heparin (LMWH) since delivery

3. Need for postpartum LMWH prophylaxis or systemic anticoagulation as judged by the local investigator. May include but is not limited to:

1. Documented history of provoked or unprovoked VTE

2. Mechanical heart valve(s)

3. Known antiphospholipid syndrome

4. 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

4. Need for postpartum aspirin as judged by the local investigator. May include but is not limited to:

1. Documented history of myocardial infarction

2. Documented history of ischemic stroke or transient ischemic attack (TIA)

5. Contraindication to aspirin including:

1. History of known aspirin allergy

2. Documented history of a gastrointestinal ulcer

3. Known platelet count <50 x 109/L at any time during the current pregnancy or postpartum

4. Active bleeding at any site, excluding normal vaginal bleeding, at the time of randomization

5. Most recent known hemoglobin ≤70 g/L documented during the current pregnancy or postpartum

6. Known severe hypertension (SBP >200mm/hg and/or DBP >120mm/hg) during the current pregnancy or postpartum

6. <18 years of age

7. Unable or refused consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network

NETWORK

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leslie Skeith, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Marc Rodger, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Foothills Medical Centre

Calgary, Alberta, Canada

British Columbia Women's Hospital & Health Centre

Vancouver, British Columbia, Canada

The Ottawa Hospital - General Campus

Ottawa, Ontario, Canada

Mount Sinai Hospital

Toronto, Ontario, Canada

Centre Hospitalier Universitaire de Saint-Etienne

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

Rotunda Hospital

Dublin, , Ireland

The Amsterdam Medical Centre

Amsterdam, North Holland, Netherlands

Countries

Canada; France; Ireland; Netherlands

References

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.

Reference Type: DERIVED

PMID: 39827892 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39238110 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33779986 (View on PubMed)

Other Identifiers

REB19-1237

Identifier Type: -

Identifier Source: org_study_id