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Nonsteroidal Anti-inflammatory Drug

Aspirin for Preeclampsia

Phase 4

Recruiting

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pregnant Adults between 18 and 45 years of age

Be between 18 and 65 years old

Must not have

Patients with preexisting cardiomyopathy, chronic hypertension, ischemic or valvular heart disease, pulmonary disease, diabetes mellitus, chronic kidney disease, multiple gestation

Those who cannot provide consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial is testing if aspirin can lower postpartum Activin A levels in women with preeclampsia, with the hypothesis that this could improve outcomes.

Who is the study for?

This trial is for pregnant adults aged 18-45 diagnosed with preeclampsia and expecting one baby. It's not for those planning to deliver outside the study site, involved in other trials, or with conditions like ulcers, bleeding disorders, heart disease, diabetes, kidney issues or multiple pregnancies. Also excluded are those allergic to aspirin or needing NSAIDs.

What is being tested?

The trial tests if low-dose aspirin (81 mg) can lower Activin A levels postpartum and improve heart function in women with preeclampsia compared to a placebo. Participants will be randomly assigned to either the aspirin group or placebo group without knowing which they're receiving.

What are the potential side effects?

Aspirin may cause side effects such as gastrointestinal issues like stomach pain and bleeding risks. Although it's a low dose being tested, participants should still be aware of potential reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am pregnant and between 18 and 45 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of heart, lung, kidney disease, diabetes, or was pregnant with multiples.

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I am unable to give consent by myself.

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I am taking or plan to take NSAIDs during the study.

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I am either required to take aspirin or cannot take it due to health reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Difference in Activin A levels

GLS percentages

Secondary study objectives

Deceleration Time

Ejection Fraction %

Left Atrial Volume Index

+2 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Intervention ArmActive Control1 Intervention

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

Group II: Observational ArmActive Control1 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.

Group III: Placebo ArmPlacebo Group1 Intervention

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

0 / 5Eligibility criteria met