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Nonsteroidal Anti-inflammatory Drug

Aspirin for Pre-eclampsia

Phase 2

Recruiting

Led By Aleha Aziz, MD, MPH

Research Sponsored by Columbia University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 weeks postpartum

Summary

This trialwill study the effects of low-dose aspirin on women with severe preeclampsia post-delivery, to see if it helps improve their condition.

Who is the study for?

This trial is for women over the age of 18 who were diagnosed with severe preeclampsia before giving birth, regardless of whether they had a single or multiple pregnancy and were at least 20 weeks into their pregnancy. It's not open to those who don't meet these criteria.

What is being tested?

The study is testing if taking low-dose aspirin (81mg) daily for three weeks after delivery helps improve blood vessel function and reduces disease severity in women with severe preeclampsia, compared to a placebo.

What are the potential side effects?

Low-dose aspirin may cause minor side effects such as stomach pain, heartburn, or nausea. More serious risks include bleeding complications, although these are less common.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 weeks postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 weeks postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 weeks postpartum for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Flow-Mediated Dilation (FMD)

Secondary study objectives

Change in Diastolic blood pressure

Body Weight Changes

Magnesium sulfate re-administration

+3 more

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Healthy Controls GroupActive Control1 Intervention

Subjects who are healthy volunteers (n = 10) without severe preeclampsia prior to delivery.

Group II: Low-Dose Aspirin (LDA) Intervention GroupActive Control1 Intervention

Subjects diagnosed with severe preeclampsia prior to delivery (antepartum or intrapartum) will take 81mg of aspirin daily for up to 3 weeks postpartum, starting within 4 days after delivery.

Group III: Placebo Control GroupPlacebo Group1 Intervention

Subjects diagnosed with severe preeclampsia prior to delivery (antepartum or intrapartum) will take placebo oral capsule daily for up to 3 weeks postpartum, starting within 4 days after delivery.

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Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,486 Previous Clinical Trials

2,655,152 Total Patients Enrolled

Aleha Aziz, MD, MPH5.05 ReviewsPrincipal Investigator - Columbia University

Columbia University

5Patient Review

Doctor Aziz is one of the best doctors I have ever had. Not only she is very knowledgeble and professional, she is also very caring and loving person. My husband and I were referred to Columbia Presbyterian Hospital due to complex pregnancy with my twin girls. Doctor Aziz made sure we feel comfortable and was very detailed oriented when explaining anything related to my health. She spoke in a way that was easy to understand. She also delivered by twin girls and we are forever thankful for that! I highly recommend her to anyone who need the best possible care from one of the most caring doctors!

Natalie Bello, MD, MPHPrincipal InvestigatorAssistant Professor of Medicine