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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 : Recruiting
First Posted : November 6, 2019
Last Update Posted : October 20, 2020
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

Tracking Information
First Submitted Date  ICMJE November 4, 2019
First Posted Date  ICMJE November 6, 2019
Last Update Posted Date October 20, 2020
Actual Study Start Date  ICMJE October 7, 2020
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2019)
Recruitment Rate [ Time Frame: 6 months ]
Mean recruitment rate per center per month
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2019)
  • Consent Rate [ Time Frame: 6 months ]
    Proportion of eligible subjects who provide consent
  • Withdrawals/Loss to Follow-up [ Time Frame: 9 months ]
    Proportion of withdrawals/loss to follow-up among participants
  • Study Drug Compliance [ Time Frame: 6 months ]
    Level of compliance with study drug through participant recall and medication diary
  • 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.
  • VTE Event Rate [ Time Frame: 6 months ]
    A more precise estimate of the VTE event rate
  • Bleeding Event Rate [ Time Frame: 6 months ]
    A more precise estimate of the major and clinically relevant non-major bleeding event rate
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot PARTUM Trial: Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity
Official Title  ICMJE A Pilot Study Assessing the Feasibility of a Randomized Controlled Trial Evaluating Aspirin in Postpartum Women at Risk of Developing Venous Thromboembolism
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Venous Thromboembolism
  • Postpartum Period
  • Aspirin
Intervention  ICMJE
  • Drug: Aspirin 81 mg
    Aspirin 81 mg p.o. daily
    Other Names:
    • acetylsalicylic acid
    • ASA
  • Drug: Placebo
    Placebo p.o. daily
Study Arms  ICMJE
  • Active Comparator: Aspirin
    Aspirin 81 mg daily for six weeks post-randomization (postpartum)
    Intervention: Drug: Aspirin 81 mg
  • Placebo Comparator: Placebo
    Placebo daily for six weeks post-randomization (postpartum)
    Intervention: Drug: Placebo
Publications * 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:CD001689. doi: 10.1002/14651858.CD001689.pub4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 4, 2019)
336
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Leslie Skeith, MD 403-944-5246 laskeith@ucalgary.ca
Contact: Alexandra Garven, BSc 403-220-7631 alexandra.garven@ucalgary.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04153760
Other Study ID Numbers  ICMJE REB19-1237
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Calgary
Study Sponsor  ICMJE University of Calgary
Collaborators  ICMJE
  • Canadian Institutes of Health Research (CIHR)
  • Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network
Investigators  ICMJE
Principal Investigator: Leslie Skeith, MD University of Calgary
Principal Investigator: Marc Rodger, MD Ottawa Hospital Research Institute
PRS Account University of Calgary
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP