Aspirin and Preeclampsia

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT04479072
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Preeclampsia Postpartum

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Feb 15, 2021
Status verified
Apr 2026
Primary completion
Dec 1, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

Difference in Activin A levels [ Time Frame: 6 Months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Chicago HospitalChicagoIllinois60637
Sajid Shahul, MD, PhD
[email protected]
773-398-2956
John Dreixler, PhD
[email protected]
773-702-6700
Sarosh Rana, MD (SUB_INVESTIGATOR)

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By research site
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