Comparative Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The overall goal of this large, pragmatic, comparative effectiveness trial is to test the hypothesis that among at-risk individuals, 162 mg/day aspirin is superior to 81 mg/day in preventing Hypertensive disorders of pregnancy (HDP), and that there are multiple factors associated with adherence with aspirin therapy that will be important to identify to enable optimal implementation of study findings and population-level benefits.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 14
Maximum Age: 35
Healthy Volunteers: f
View:

• live intrauterine gestation ≤16 6/7 weeks gestational age based on best clinical obstetric estimate,

• age 14 years or older and able to provide informed consent,

• at least one of the following high-risk criteria: i) any prior pregnancy complicated by preeclampsia ii) current pregnancy complicated by chronic hypertension diagnosed before randomization (ACOG) iii) pre-gestational diabetes (on medication for diabetes prior to pregnancy, or diabetes is diagnosed prior to randomization with hemoglobin A1C of 6.5% or greater or abnormal 3-hour glucose tolerance test) iv) twin gestation (including higher order pregnancy reduced to twins prior to 14 weeks) v) chronic kidney disease vi) autoimmune disease (e.g., antiphospholipid syndrome, systemic lupus erythematous)

• or two or more moderate-risk criteria for HDP (per USPSTF), i) nulliparity (no prior delivery at or after 20 weeks 0 days of gestation) ii) obesity (body mass index ≥30 kg/m2 at time of randomization) iii) age ≥35 years (at time of expected estimated due date) iv) Black race v) low income vi) personal risk factors (previous pregnancy with low birth weight or SGA infant, previous adverse pregnancy outcome \[unexplained stillbirth\], placental abruption, interval \>10 years between pregnancies) vii) Family history of preeclampsia (i.e., mother or sister) viii) In vitro fertilization

• patient not currently on aspirin OR patient on aspirin for obstetrical indications (e.g., related to IVF, or HDP) and: i- randomized before 130/7 weeks gestation, or ii- randomized on or after 13 0/7 weeks gestation and started aspirin within 2 weeks prior to randomization (e.g., aspirin started for HDP prevention at 12 0/7 weeks and patient randomized at 13 2/7 weeks).

Locations
United States
California
Cedars Sinai Medical Center
RECRUITING
Los Angeles
University of California, San Francisco
RECRUITING
San Francisco
Illinois
Northwestern University
RECRUITING
Chicago
Mississippi
University of Mississippi
RECRUITING
Jackson
North Carolina
University of North Carolina, Chapel Hill
RECRUITING
Chapel Hill
New Mexico
University of New Mexico
RECRUITING
Albuquerque
New York
Columbia University
RECRUITING
New York
Ohio
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
RECRUITING
Columbus
Pennsylvania
University of Pittsburg Magee
RECRUITING
Pittsburgh
Rhode Island
Brown University
RECRUITING
Providence
Texas
University of Texas, Houston
RECRUITING
Houston
Virginia
Eastern Virginia Medical School - Old Dominion University
RECRUITING
Norfolk
Contact Information
Primary
Maged Costantine, MD, MBA
Maged.Costantine@osumc.edu
614-293-2222
Backup
Kara Rood, MD
Kara.Rood@osumc.edu
614-293-8045
Time Frame
Start Date: 2024-10-18
Estimated Completion Date: 2030-02-01
Participants
Target number of participants: 10742
Treatments
Experimental: 81 mg Aspirin
Treatment A consisting of 81mg of aspirin (1 pill of 81mg \& 1 matching placebo) daily
Experimental: 162 mg Aspirin
Treatment B consisting of 162mg of aspirin (2 pills, each of 81mg) daily
Related Therapeutic Areas
Sponsors
Collaborators: Northwestern University, Preeclampsia Foundation, Patient-Centered Outcomes Research Institute
Leads: Ohio State University

This content was sourced from clinicaltrials.gov

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