AzTrials
AzTrials

Venous ThromboembolismEarly Phase 1PARTUMNCT04153760

Pilot PARTUM Trial: Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity

A Early Phase 1 study testing Aspirin 81 mg in people with Venous Thromboembolism and Postpartum Period, run by University of Calgary at 7 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Venous Thromboembolism, Postpartum Period, Aspirin
What is being tested?
Aspirin 81 mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
257 participants
Where
7 sitesin 4 countries
Study dates
7 Oct 2020to 5 Sep 2023
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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
Show all 19Show fewer
  • 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
  • Most recent known hemoglobin ≤70 g/L documented during the current pregnancy or postpartum
  • Known severe hypertension (SBP >200mm/hg and/or DBP >120mm/hg) during the current pregnancy or postpartum
  • <18 years of age
  • Unable or refused consent

Trial locations and contacts

7 sites in 4 countries.

7 sites in 4 countries

Canada4 sites

  • Foothills Medical Centre

    Calgary, Alberta, T2N 2T9

  • The Ottawa Hospital - General Campus

    Ottawa, Ontario, K1H 8L6

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1Z5

  • British Columbia Women's Hospital & Health Centre

    Vancouver, British Columbia, V6H 3N1

Other trials in Canada

France1 site

  • Centre Hospitalier Universitaire de Saint-Etienne

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

Other trials in France

Ireland1 site

  • Rotunda Hospital

    Dublin, D01 P5W9

Other trials in Ireland

Netherlands1 site

  • The Amsterdam Medical Centre

    Amsterdam, North Holland, 1105

Other trials in Netherlands

About this study

Official title: A Pilot Study Assessing the Feasibility of a Randomized Controlled Trial Evaluating Aspirin in Postpartum Women at Risk of Developing Venous Thromboembolism

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.

Read the 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.

Being tested
Aspirin 81 mg, Placebo
Keywords
deep vein thrombosis, pulmonary embolism, postpartum, pregnancy, thrombophilia, cesarean delivery, pre-eclampsia, postpartum hemorrhage
Medical subject headings
Venous Thromboembolism, Venous Thrombosis, Pulmonary Embolism, Thrombophilia, Pre-Eclampsia, Postpartum Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aspirin 81 mgDrug

    Also called acetylsalicylic acid, ASA

    Aspirin 81 mg p.o. daily

  • PlaceboDrug

    Placebo p.o. daily

Study groups in NCT04153760
Study groupRoleWhat they receive
AspirinActive comparatorAspirin 81 mg daily for six weeks post-randomization (postpartum)
Receives: Drug: Aspirin 81 mg
PlaceboPlacebo comparatorPlacebo daily for six weeks post-randomization (postpartum)
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment Rate

    Mean recruitment rate per center per month

    Measured: 6 months

Secondary outcomes (6)

  1. Consent Rate

    Proportion of eligible subjects who provide consent

    Measured: 6 months

  2. Withdrawals/Loss to Follow-up

    Proportion of withdrawals/loss to follow-up among participants

    Measured: 9 months

  3. Study Drug Compliance

    Level of compliance with study drug through participant recall and medication diary

    Measured: 6 months

  4. Time Required to Obtain Site Institutional Approvals

    Proportion of sites requiring >18 months to obtain all required approvals/contracts from time of delivery of all study documents.

    Measured: 24 months

  5. VTE Event Rate

    A more precise estimate of the VTE event rate

    Measured: 6 months

  6. Bleeding Event Rate

    A more precise estimate of the major and clinically relevant non-major bleeding event rate

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2019
  2. Study start7 Oct 2020
  3. Primary completion5 Sep 2023
  4. Study completion5 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
257 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04153760
Sponsor's protocol ID
REB19-1237
Acronym
PARTUM
Status last verified
Sep 2023
First submitted
4 Nov 2019
Last updated
13 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39827892

  • 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.

    PubMed 39238110

  • 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.

    PubMed 33779986

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Aspirin 81 mg in people with Venous Thromboembolism and Postpartum Period, run by University of Calgary at 7 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Canada, France, Ireland, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment Rate (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04153760, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in