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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am pregnant and between 18 and 45 years old.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Difference in Activin A levels

GLS percentages

Secondary outcome measures

Deceleration Time

Ejection Fraction %

Left Atrial Volume Index

+2 more

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor

1,003 Previous Clinical Trials

819,569 Total Patients Enrolled

Media Library

Aspirin (Nonsteroidal Anti-inflammatory Drug) Clinical Trial Eligibility Overview. Trial Name: NCT04479072 — Phase 4

Pre-eclampsia Research Study Groups: Intervention Arm, Placebo Arm, Observational Arm

Pre-eclampsia Clinical Trial 2023: Aspirin Highlights & Side Effects. Trial Name: NCT04479072 — Phase 4

Aspirin (Nonsteroidal Anti-inflammatory Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04479072 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Intervention Arm been validated by the FDA?

"Due to the Phase 4 designation, Intervention Arm has been assessed as a 3 in terms of safety. This indicates that this particular treatment has already received approval from the relevant regulatory bodies."

Answered by AI

Are there any available opportunities for participation in this research project?

"According to the information pulled from clinicaltrials.gov, this medical study is currently in a recruitment phase; it was initially posted on February 15th 2021 and most recently updated November 23rd 2022."

Answered by AI

Does this medical experiment have an age requirement of over 20 years old?

"This research trial is seeking patients aged 18-45 years old."

Answered by AI

How many participants are taking part in this clinical research endeavor?

"Affirmative. Per records on clinicaltrials.gov, this research project began enrolling participants since February 15th 2021 and was last updated in November 23rd 2022. 180 patients are needed for the trial to be conducted at a single medical site."

Answered by AI

What maladies has Intervention Arm been most successfully deployed to alleviate?

"Percutaneous coronary intervention (PCI) is typically treated with Intervention Arm, though it has also seen success in treating dental procedures, inflammation and neck pain."

Answered by AI

What are the main aims of this research project?

"This clinical trial will measure the primary outcome, Activin A levels, over approximately 6 months. Secondary outcomes include Mitral Annular Motion (mm), Mean Arterial Pressure and Left Atrial Volume Index compared to baseline values at the end of this period."

Answered by AI

Can you provide any insight into the groundbreaking nature of this clinical trial?

"As of now, 167 trials are in progress for Intervention Arm in 1398 cities and 57 nations. This journey began back in 2005 when Abbott sponsored a trial involving 15480 participants that was ultimately approved during Phase 4. Subsequently, 18770 studies have been conducted regarding this intervention."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Aspirin and Preeclampsia

2021. "Aspirin and Preeclampsia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04479072.

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