Aspirin and Preeclampsia

NCT04479072 | Recruiting Phase 4 FDA Drug

• 1 other identifier: IRB18-1606
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  6 Months

• 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.

  6 months

Secondary Outcomes (5)

• Mean Arterial Pressure

  6 Months

• Ejection Fraction %

  6 Months

• Deceleration Time

  6 Months

• Mitral Annular Motion

  6 Months

• Left Atrial Volume Index

  6 Months

Study Arms (3)

Intervention Arm

ACTIVE COMPARATOR

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

Drug: Aspirin 81 mg

Placebo Arm

PLACEBO COMPARATOR

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

Drug: Placebo

Observational Arm

NO INTERVENTION

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 DRUG

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.

Also known as: acetylsalicylic acid 81 mg

Intervention Arm

Placebo DRUG

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.

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant women with preeclampsia
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Hospital

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia; Hypertension; Cardiovascular Diseases

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Sajid Shahul, MD, PhD

CONTACT

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

Colleen Duncan, RN

CONTACT

7738342892; cduncan@bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The study team and all randomized subjects will be blinded to which arm they were placed in during the main part of the study. Subjects in the observational group will not be randomized and not given an intervention. The sub-study portion has no blinding attached to it
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 21, 2020
• Study Start: February 15, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)