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Could a simple aspirin pill replace daily shots to prevent postpartum blood clots?

NCT ID NCT06494878

Prevention Sponsor: University of Calgary Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time

Summary

This trial tests whether taking a low-dose aspirin pill every day for six weeks after delivery can prevent dangerous blood clots in the legs or lungs as effectively as the standard daily heparin injections. The study enrolls people who have given birth and have one or more risk factors for blood clots. If aspirin proves non-inferior, it could offer a more convenient and less invasive prevention option.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
low-dose aspirin (75-100 mg daily by mouth) compared to low-molecular-weight heparin injections
What this could lead to
If aspirin works as well as heparin, it could offer a simpler, pill-based way to prevent postpartum blood clots, reducing the need for daily injections.
What could go wrong
This is a large trial, but aspirin may prove less effective than heparin for some high-risk individuals. Bleeding risks with aspirin also need careful monitoring.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 8,805 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * ONE (or more) First Order Criterion: 1. Known inherited thrombophilia diagnosed prior to enrolment, regardless of family history of VTE: i. Heterozygous factor V Leiden, or ii. Heterozygous prothrombin gene variant, or iii. Protein C deficiency, or iv. Protein S deficiency, and/or 2. Antepartum immobilization for ≥7 days. Immobilization is defined as bed rest with 90% of waking hours spent in bed at any time during the antepartum period AND/OR TWO (or more) Second Order Criteria: 1. Pre-pregnancy BMI ≥30 kg/m² 2. Smoking in the current pregnancy or within 3 months prior to pregnancy 3. Previous clinical history of superficial vein thrombosis 4. Preeclampsia 5. Current pregnancy ending in stillbirth (pregnancy loss \>20 weeks gestation) 6. Unplanned cesarean delivery (unplanned = not a scheduled cesarean delivery) 7. Small-for-gestational-age infant at time of delivery (\<3rd percentile adjusted for gestational age and sex) 8. Peripartum or postpartum infection (symptoms/signs of infection and documented fever and laboratory evidence of infection with positive blood cultures or an elevated white blood cell count based on local laboratory cutoffs) 9. Postpartum hemorrhage (≥1000 mL of blood loss, regardless of delivery mode) Exclusion Criteria: 1. More than 48 hours since delivery at the time of randomization 2. Received more than 1 dose of LMWH since delivery 3. Need for postpartum LMWH prophylaxis or systemic anticoagulation as judged by their physician and/or 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 (APS) 4. Known high-risk inherited thrombophilia i) Antithrombin deficiency, or ii) Homozygous factor V Leiden, or iii) Homozygous prothrombin gene mutation, or iv) More than 1 thrombophilia: any combination of 2 or more: factor V Leiden, prothrombin gene mutation, protein C deficiency, protein S deficiency 4. Need for postpartum ASA as judged by their physician and/or 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. Active bleeding, excluding normal vaginal bleeding, at the time of randomization 6. Known medical condition as judged by their physician and/or local investigator to be a contraindication to ASA or LMWH including known ASA or LMWH allergy 7. \<18 years of age 8. Unable or declined consent

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Conditions

The condition(s) this trial relates to.

Postpartum Hemorrhage preeclampsia pulmonary embolism thrombophilia Venous Thrombosis venous thromboembolism prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aspirin Low molecular weight heparin Postpartum period Venous thromboembolism

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites in 7 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • APHP - Hôpital Port Royal

    NOT_YET_RECRUITING

    Paris, 75014, France

  • Amsterdam UMC

    NOT_YET_RECRUITING

    Amsterdam, 1105AZ, Netherlands

  • Association Hospitalière De Bruxelles Et De Schaerbeek - Centre Hospitalier Universitaire Brugmann

    NOT_YET_RECRUITING

    Brussels, 1020, Belgium

  • CHU de Nancy

    NOT_YET_RECRUITING

    Nancy, 54000, France

  • CHU de Saint-Etienne

    NOT_YET_RECRUITING

    Saint-Etienne, 42055, France

  • CHU de Toulouse

    NOT_YET_RECRUITING

    Toulouse, 31059, France

  • Foothills Medical Centre

    RECRUITING

    Calgary, Alberta, T2N 2T9, Canada

  • Hvidovre Hospital

    NOT_YET_RECRUITING

    Hvidovre, Capital Region, 2650, Denmark

  • Medical University of Warsaw

    NOT_YET_RECRUITING

    Warsaw, 02-091, Poland

  • Rotunda Hospital, RCSI Department of Obstetrics and Gynaecology

    NOT_YET_RECRUITING

    Dublin, D01 P5W9, Ireland

  • The Ottawa Hospital - General Campus

    NOT_YET_RECRUITING

    Ottawa, Ontario, K1H 8L6, Canada

  • UCD Centre for Human Reproduction, The Coombe Hospital

    NOT_YET_RECRUITING

    Dublin, D08XW7X, Ireland

More trials for these conditions

Other studies related to the condition(s) this trial covers.