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Pilot PARTUM Trial: Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity (PARTUM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04153760
Recruitment Status : Recruiting
First Posted : November 6, 2019
Last Update Posted : May 12, 2023
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network
Information provided by (Responsible Party):
University of Calgary

Study Description
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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.

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Postpartum Period Aspirin Drug: Aspirin 81 mg Drug: Placebo Early Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 384 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Pilot Study Assessing the Feasibility of a Randomized Controlled Trial Evaluating Aspirin in Postpartum Women at Risk of Developing Venous Thromboembolism
Actual Study Start Date : October 7, 2020
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Aspirin
Aspirin 81 mg daily for six weeks post-randomization (postpartum)
 Drug: Aspirin 81 mg
Aspirin 81 mg p.o. daily
Other Names:
  • acetylsalicylic acid
  • ASA
Placebo Comparator: Placebo
Placebo daily for six weeks post-randomization (postpartum)
 Drug: Placebo
Placebo p.o. daily


Outcome Measures
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Primary Outcome Measures :
  1. Recruitment Rate [ Time Frame: 6 months ]
    Mean recruitment rate per center per month


Secondary Outcome Measures :
  1. Consent Rate [ Time Frame: 6 months ]
    Proportion of eligible subjects who provide consent

  2. Withdrawals/Loss to Follow-up [ Time Frame: 9 months ]
    Proportion of withdrawals/loss to follow-up among participants

  3. Study Drug Compliance [ Time Frame: 6 months ]
    Level of compliance with study drug through participant recall and medication diary

  4. Time Required to Obtain Site Institutional Approvals [ Time Frame: 24 months ]
    Proportion of sites requiring >18 months to obtain all required approvals/contracts from time of delivery of all study documents.

  5. VTE Event Rate [ Time Frame: 6 months ]
    A more precise estimate of the VTE event rate

  6. Bleeding Event Rate [ Time Frame: 6 months ]
    A more precise estimate of the major and clinically relevant non-major bleeding event rate


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Study inclusion criteria includes one (or more) first order criterion or two (or more) second order criteria. A patient is still eligible if they have multiple criteria met, at the discretion of the local investigator.

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04153760


Contacts
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Contact: Leslie Skeith, MD 403-944-5246 laskeith@ucalgary.ca
Contact: Alexandra Garven, BSc 403-220-7631 alexandra.garven@ucalgary.ca

Locations
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Canada, Alberta
Foothills Medical Centre Completed
Calgary, Alberta, Canada, T2N 2T9
Canada, British Columbia
British Columbia Women's Hospital & Health Centre Active, not recruiting
Vancouver, British Columbia, Canada, V6H 3N1
Canada, Ontario
The Ottawa Hospital - General Campus Active, not recruiting
Ottawa, Ontario, Canada, K1H 8L6
Mount Sinai Hospital Active, not recruiting
Toronto, Ontario, Canada, M5G 1Z5
France
Centre Hospitalier Universitaire de Saint-Etienne Completed
Saint-Étienne, Loire, France, 42270
Ireland
Rotunda Hospital Completed
Dublin, Ireland, D01 P5W9
Netherlands
The Amsterdam Medical Centre Recruiting
Amsterdam, North Holland, Netherlands, 1105
Contact: Wessel Ganzevoort, MD       j.w.ganzevoort@amsterdamumc.nl   
Contact: Hanke Wiegers, MD       h.m.wiegers@amsterdamumc.nl   
Sponsors and Collaborators
University of Calgary
Canadian Institutes of Health Research (CIHR)
Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network
Investigators
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Principal Investigator: Leslie Skeith, MD University of Calgary
Principal Investigator: Marc Rodger, MD McGill University Health Centre/Research Institute of the McGill University Health Centre
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Calgary
ClinicalTrials.gov Identifier: NCT04153760    
Other Study ID Numbers: REB19-1237
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: May 12, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Calgary:
deep vein thrombosis
pulmonary embolism
postpartum
pregnancy
 thrombophilia
cesarean delivery
pre-eclampsia
postpartum hemorrhage
Additional relevant MeSH terms:
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Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics