Health TrialsbyHealthPanel

Aspirin and Preeclampsia

ConditionPreeclampsia Postpartum
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorUniversity of Chicago

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pregnant Adults between 18 and 45 years of age

Diagnosed with preeclampsia

Presenting for delivery with a singleton gestation.

Disqualifiers

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.

Trial design

Design model

Factorial

Treatments tested in this trial

  • 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.

Treatment groups

180 Participants
are divided into 3 treatment groups
Group A: Intervention ArmActive comparator 1 intervention
Group B: Placebo ArmPlacebo comparator 1 intervention
Group C: Observational ArmNo intervention 0 interventions

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
6 months

Secondary outcomes

1

Mean Arterial Pressure

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

Time frame
6 Months
2

Ejection Fraction %

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

Time frame
6 Months
3

Deceleration Time

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

Time frame
6 Months
4

Mitral Annular Motion

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

Time frame
6 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Chicago

Lead sponsor

Source ClinicalTrials.gov
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