Recruiting

Aspirin & Preeclampsia

Sponsor:

University of Chicago

Code:

NCT04479072

Conditions

Preeclampsia Postpartum

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Aspirin 81 mg

Placebo

Study Details

Brief 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 therapy will improve (GLS) in preeclamptic patients.

Conditions

Preeclampsia Postpartum

Study ID

NCT04479072

Start date

Feb 15, 2021

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Intervention Arm

60 subjects will be randomly assigned to this arm. The subjects in this arm will receive a daily dose of aspirin 81 mg.

placebo comparator: Placebo Arm

60 subjects will be randomly assigned to this arm. The subjects in this arm will receive a daily dose of a placebo pill

no intervention: Observational Arm

60 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.

Interventions

Aspirin 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.

Placebo

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.

Primary outcome measure

  • Difference in Activin A levels [ Time Frame: 6 Months ]
  • GLS percentages [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Sajid Shahul, MD, PhD

773-398-2956sshahul1@dacc.uchicago.edu

Colleen Duncan, RN

7738342892cduncan@bsd.uchicago.edu

Locations

University of Chicago Hospital

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Sajid Shahul, MD, PhD

773-398-2956sshahul1@dacc.uchicago.edu

John Dreixler, PhD

773-702-6700JDreixle@dacc.uchicago.edu

More Information

Sponsor

University of Chicago

Last update posted

May 4, 2026

Last verified

Apr, 2026

Keywords

  • Preeclampsia
  • Postpartum GLS Levels
  • Postpartum Activin A Levels
  • Aspirin
  • Cardiac Postpartum Therapy
  • Hypertension
  • Cardiovascular disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-05-04.