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

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ClinicalTrials.gov Identifier: NCT04153760
Recruitment Status : Not yet recruiting
First Posted : November 6, 2019
Last Update Posted : November 6, 2019
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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 336 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
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care
Drug Information available for: Aspirin

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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 ≤80 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

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: Erin Woods, BSc 403-944-5246 erin.woods1@ucalgary.ca

Locations
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Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
Contact: Leslie Skeith, MD    403-944-5246    laskeith@ucalgary.ca   
Contact: Erin Woods, BSc    403-944-5246    erin.woods1@ucalgary.ca   
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 Ottawa Hospital Research Institute

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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: November 6, 2019
Last Verified: November 2019
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