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Nonsteroidal Anti-inflammatory Drug

Aspirin 81mg for Pre-eclampsia

Phase 4
Waitlist Available
Led By Tetsuya Kawakita, MD
Research Sponsored by Eastern Virginia Medical School
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 after 20 weeks gestation
Awards & highlights
Pivotal Trial
Approved for 10 Other Conditions
All Individual Drugs Already Approved
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial is testing whether low-dose aspirin can help prevent preeclampsia in women with stage 1 hypertension.

Eligible Conditions
  • Pre-eclampsia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~prior to 37 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to 37 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Preterm Preeclampsia
Secondary study objectives
Eclampsia
Gestational Hypertension
HELLP Syndrome
+1 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: AspirinExperimental Treatment1 Intervention
Participants in this arm will be instructed to take 1 81mg aspirin daily beginning between weeks 12 and 16 of pregnancy and continuing until delivery.
Group II: No AspirinActive Control1 Intervention
Participants in this arm will receive no aspirin.

Find a Location

Who is running the clinical trial?

AMAG Pharmaceuticals, Inc.Industry Sponsor
43 Previous Clinical Trials
11,254 Total Patients Enrolled
Eastern Virginia Medical SchoolLead Sponsor
73 Previous Clinical Trials
15,645 Total Patients Enrolled
Tetsuya Kawakita, MDPrincipal InvestigatorEastern Virginia Medical School
2 Previous Clinical Trials
250 Total Patients Enrolled
~14 spots leftby Nov 2025
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