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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
Awards & highlights
Study 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.
Eligible Conditions
- Postpartum preeclampsia
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Flow-Mediated Dilation (FMD)
Secondary outcome measures
Change in Diastolic blood pressure
Body Weight Changes
Magnesium sulfate re-administration
+3 moreTrial 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
1,431 Previous Clinical Trials
2,460,733 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
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with severe preeclampsia before giving birth.You are at least 18 years old and a mother.You are either pregnant with one baby or multiple babies.You are at least 20 weeks pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: Healthy Controls Group
- Group 2: Low-Dose Aspirin (LDA) Intervention Group
- Group 3: Placebo Control Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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