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Nonsteroidal Anti-inflammatory Drug
Aspirin for Pre-eclampsia (ASPERIN Trial)
Phase 2
Waitlist Available
Led By John M O'Brien, MD
Research Sponsored by John O'Brien, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three times between 11 and 32 weeks of gestation
Awards & highlights
Approved for 10 Other Conditions
No Placebo-Only Group
All Individual Drugs Already Approved
Summary
This trial will help determine if Aspirin has a dose-dependent response in reducing adverse outcomes related to preeclampsia.
Eligible Conditions
- Pre-eclampsia
- Severe Preeclampsia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ three times between 11 and 32 weeks of gestation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~three times between 11 and 32 weeks of gestation
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Pulsatility Index (PI)
Secondary study objectives
Change in CRP levels over time
Change in IL-6 over time
Change in PIGF levels over time
+5 moreAwards & Highlights
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Acetylsalicylic Acid 81mgExperimental Treatment1 Intervention
Patients will receive low dose (81mg) acetylsalicylic acid (Aspirin).
Group II: Acetylsalicylic Acid 162mgExperimental Treatment1 Intervention
Patients will receive low dose (162mg) acetylsalicylic acid (Aspirin).
Group III: Control GroupActive Control1 Intervention
Patients will receive standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetylsalicylic acid
FDA approved
Acetylsalicylic acid
FDA approved
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Who is running the clinical trial?
John O'Brien, MDLead Sponsor
1 Previous Clinical Trials
240 Total Patients Enrolled
John M O'Brien, MDPrincipal InvestigatorUniversity of Kentucky
Katherine Vignes, MDStudy ChairUniversity of Kentucky
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Requirements for being included in the control group of the study.You have an autoimmune disease.You have had a type of high blood pressure called "preterm preeclampsia" during a previous pregnancy.You have long-term high blood pressure.You have kidney problems.You do not have any conditions that increase your risk of developing preeclampsia.You have pre-eclampsia and meet the requirements to be part of the study.You have either Type 1 or Type 2 diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Acetylsalicylic Acid 81mg
- Group 2: Acetylsalicylic Acid 162mg
- Group 3: Control Group
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
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