Acetylsalicylic Acid 162 mg for Pre-Eclampsia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Pre-Eclampsia+1 More
Acetylsalicylic Acid 162 mg - Drug
Eligibility
18 - 65
Female
What conditions do you have?
Select

Study Summary

This trial will help determine if Aspirin has a dose-dependent response in reducing adverse outcomes related to preeclampsia.

Eligible Conditions
  • Pre-Eclampsia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Three times between 11 and 32 weeks of gestation

Day 28
Composite Neonatal outcomes including frequency of Intraventricular hemorrhage (IVH), Bronchopulmonary dysplasia (BPD), Respiratory distress syndrome (RDS), Necrotising enterocolitis(NEC)
Week 32
Change in CRP levels over time
Change in IL-6 over time
Change in PIGF levels over time
Change in TNF over time
Change in s-ICAM levels over time
Week 32
Change in Pulsatility Index (PI)
Week 6
Severity of Pre-eclampsia
Week 6
Onset of Pre-eclampsia

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

3 Treatment Groups

Control Group
1 of 3
Acetylsalicylic Acid 162mg
1 of 3
Acetylsalicylic Acid 81mg
1 of 3
Active Control
Experimental Treatment

250 Total Participants · 3 Treatment Groups

Primary Treatment: Acetylsalicylic Acid 162 mg · No Placebo Group · Phase 2

Acetylsalicylic Acid 162mg
Drug
Experimental Group · 1 Intervention: Acetylsalicylic Acid 162 mg · Intervention Types: Drug
Acetylsalicylic Acid 81mg
Drug
Experimental Group · 1 Intervention: Acetylsalicylic Acid 81 mg · Intervention Types: Drug
Control Group
Other
ActiveComparator Group · 1 Intervention: Control · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: three times between 11 and 32 weeks of gestation

Who is running the clinical trial?

John O'Brien, MDLead Sponsor
Katherine Vignes, MDStudy ChairUniversity of Kentucky
John M O'Brien, MDPrincipal InvestigatorUniversity of Kentucky

Eligibility Criteria

Age 18 - 65 · Female Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a history of preterm preeclampsia.
You have chronic hypertension.
You have Type 1 or Type 2 diabetes.\n
You have an autoimmune disease.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 2nd, 2021

Last Reviewed: October 17th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.