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Preeclampsia PostpartumPhase 4NCT04479072

Aspirin and Preeclampsia

A Phase 4 study testing Aspirin 81 mg in people with Preeclampsia Postpartum, run by University of Chicago at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a single-center, double-blind, randomized, placebo-controlled clinical trial. Peripartum and postpartum Activin A are significantly elevated in women with preeclampsia. Our hypothesis is that elevated Activin A levels reflect a remediable signal and that reducing postpartum Activin A levels with aspirin… Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Preeclampsia Postpartum
What is being tested?
Aspirin 81 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
1 siteUnited States
Study dates
15 Feb 2021to 31 Dec 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

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 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Pregnant Adults between 18 and 45 years of age
  • Diagnosed with preeclampsia
  • Presenting for delivery with a singleton gestation.

Who cannot join

  • We will exclude patients in labor
  • Patients with preexisting cardiomyopathy, chronic hypertension, ischemic or valvular heart disease, pulmonary disease, diabetes mellitus, chronic kidney disease, multiple gestation
  • Plan to deliver outside of the participating site
  • Co-enrolled in other trials that might affect the patients taking the study medication, as determined by the PI.
  • Aspirin allergy
  • Clear indication for aspirin therapy or contraindication to aspirin therapy
Show all 9Show fewer
  • Clinically significant conditions that might limit adherence to trial regimen (e.g., peptic ulcer disease, history of gastrointestinal bleeds, bleeding disorders)
  • Currently or planning on taking any nonsteroidal anti-inflammatory drugs while they are participating in this study.
  • Those who cannot provide consent

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sajid Shahul, MD, PhD contact

773-398-2956

sshahul1@dacc.uchicago.edu

Colleen Duncan, RN contact

7738342892

cduncan@bsd.uchicago.edu

United States1 site, 1 recruiting
  • University of Chicago Hospital

    Chicago, Illinois, 60637

    Sajid Shahul, MD, PhD, 773-398-2956, sshahul1@dacc.uchicago.edu

    John Dreixler, PhD, 773-702-6700, JDreixle@dacc.uchicago.edu

    Recruiting

Other trials in United States

About this study

Official title: Aspirin to Prevent Cardiac Dysfunction in Preeclampsia

This is a single-center, double-blind, randomized, placebo-controlled clinical trial. Peripartum and postpartum Activin A are significantly elevated in women with preeclampsia. Our hypothesis is that elevated Activin A levels reflect a remediable signal and that reducing postpartum Activin A levels with aspirin therapy will improve (GLS) in preeclamptic patients.

Read the detailed description

The primary objective of the main part of this trial is to mechanistically compare the effect of postpartum aspirin therapy versus placebo in preeclamptic patients identified as high risk for postpartum cardiac dysfunction using Activin A. The intent is to evaluate the effect of selective treatment based on Activin A status rather than treatment for all postpartum preeclamptic women.

After informed consent, 5cc of blood will be collected from the median cubital vein on antepartum admission to labor and delivery for Activin A screening. The patient will be subjected to a total of 2 such blood draws- a single draw at screening, one at their 6 month postpartum visit. The member of the study team carrying out the blood draw will immediately label the specimen in the presence of the subject, after the collection and before leaving the patient's bedside, room, cubicle or surgical suite. The guidelines from, "The University of Chicago Medicine Policy and Procedure Manual - Phlebotomy Service Infection Control 04-26" will be followed for specimen collection and transport. Activin A levels based on our previous data will be classified as elevated if greater than 23.74 ng/ml in the last trimester of pregnancy (4). This threshold was selected on the basis of our prior data suggesting an inflection point in the rate of abnormal GLS postpartum at this concentration. Patients with elevated Activin A levels will be randomized to a placebo group receiving routine postpartum cardiovascular standard of care or to an intervention arm with 81 mg daily aspirin therapy added to care at their postpartum delivery stay. The rationale for only randomizing women with elevated Activin A levels is that among women with an elevated Activin A antepartum, 85% developed abnormalities in GLS at one year postpartum versus 25% in women with non-elevated Activin A levels. Women whose Activin A levels are not elevated will receive the same care as that provided to the placebo group and will also be followed for one year (n=60). All other subjects who meet the criterial of elevated Activin A levels, will either be randomized to the aspirin therapy group (N = 60) or a placebo group (N = 60). The investigators choose postpartum Aspirin therapy post-delivery to avoid any immediate delivery or C-section associated bleeding complications and to coincide with their postpartum well-baby visit.

The investigator will determine the blood Activin A levels at 6 months after delivery, measured using ELISA. The samples will be assayed for Activin A level using commercially available ELISA kits (Ansh Labs; Webster, TX) following the manufacturer's recommendations. Each sample will be run in triplicate and the values averaged. GLS at 6 months after delivery will be measured using fully automated vendor-independent software that uses a computer learning algorithm to facilitate endocardial border detection.

Mean arterial pressure, and other indices of systolic and diastolic function (ejection fraction (EF), early filling/atrial contraction (E/A), deceleration time (DT), mitral annular motion (E'), and left atrial volume index) measured at the baseline and 6 months postpartum. Transthoracic echocardiograms will be performed and reported according to American Society of Echocardiography guidelines. Ejection fraction and left atrial volume will be calculated using the Simpson's biplane disc method. Left ventricular mass index (LVMI) will be calculated using the area length method.

Being tested
Aspirin 81 mg, Placebo
Keywords
Preeclampsia, Postpartum GLS Levels, Postpartum Activin A Levels, Aspirin, Cardiac Postpartum Therapy, Hypertension, Cardiovascular disease
Medical subject headings
Pre-Eclampsia, Hypertension, Cardiovascular Diseases

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 81 mg

    Subjects in the interventional arm will receive a daily dose of aspirin 81 mg, starting at their baseline visit and to be taken up to their 6-month follow-up visit.

  • PlaceboDrug

    Subjects in this group will receive a daily dose of a placebo pill, starting at their baseline visit and to be taken up to their 6-month follow-up visit.

Study groups in NCT04479072
Study groupRoleWhat they receive
Intervention ArmActive comparator60 subjects will be randomly assigned to this arm. The subjects in this arm will receive a daily dose of aspirin 81 mg.
Receives: Drug: Aspirin 81 mg
Placebo ArmPlacebo comparator60 subjects will be randomly assigned to this arm. The subjects in this arm will receive a daily dose of a placebo pill
Receives: Drug: Placebo
Observational ArmNo intervention60 subjects will be placed in the observational arm. These subjects will not receive any intervention but will be followed and asked to return at the same time interval as the other 2 groups.

What is being measured

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

  1. Difference in Activin A levels

    The primary outcome will compare Activin A levels at 6 months between patients randomized to aspirin therapy versus placebo and the observational group.

    Measured: 6 Months

  2. GLS percentages

    The primary outcome will compare GLS levels as a percentage (%) at 6 months between patients randomized to aspirin therapy versus placebo and the observational group.

    Measured: 6 months

Secondary outcomes (5)
  1. Mean Arterial Pressure

    Difference in mean arterial pressure in subjects, from their baseline to 6 month TTE

    Measured: 6 Months

  2. Ejection Fraction %

    Comparing the difference in the ejection fraction percentages, from the subjects baseline to 6 month TEE.

    Measured: 6 Months

  3. Deceleration Time

    Comparing the difference between deceleration time from subjects from their baseline to 6 month TTE.

    Measured: 6 Months

  4. Mitral Annular Motion

    Comparing the difference between mitral annular motion, in millimeters (mm), from subjects baseline to 6 month TTE.

    Measured: 6 Months

  5. Left Atrial Volume Index

    Comparing the difference between left atrial volume index, from the subjects baseline to 6 month TTE.

    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 posted21 Jul 2020
  2. Study start15 Feb 2021
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

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
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Model description
Main Study: Subjects will be randomized to two arms. One arm will receive a daily dose of aspirin 81 mg, starting at their baseline visit. The other arm will receive daily dose of placebo pill at their baseline visit. There will be a third arm, where subjects will not receive any study drug and will be considered the observational arm. Sub-Study: Subjects who completed the main part of the study and choose to participate will be randomized once more into one of two arms for the purposes of the sub-study. One arm will receive the GDMP, which includes the RPM program. The other arm will not receive the GDMP and will continue thier usual standard of care course per thier treating physician.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04479072
Sponsor's protocol ID
IRB18-1606
Status last verified
Apr 2026
First submitted
13 Jul 2020
Last updated
4 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aspirin 81 mg in people with Preeclampsia Postpartum, run by University of Chicago at 1 site in United States.

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 3 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Sajid Shahul, MD, PhD (773-398-2956, sshahul1@dacc.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in Activin A levels (time frame: 6 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 4 May 2026.

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