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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Ohio State University
Study ID
NCT06468202
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Gestational Hypertension
  • Hypertensive Disorders of Pregnancy
  • Preeclampsia

Eligibility Criteria

Sex
FEMALE
Age
14 Years - 35 Years
Healthy Volunteers
Not accepted

Interventions

  • Aspirin 81 mg — DRUG
    Participants will be assigned to 81mg Aspirin
  • Aspirin 162 mg — DRUG
    Participants will be assigned to 162mg Aspirin

Study Details

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.

Key Dates

Start date
Oct 18, 2024
Status verified
Apr 2026
Primary completion
Jan 1, 2029
Completion
Feb 1, 2030

Study Design

Enrollment
10,742 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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

Primary Outcome Measure

Hypertensive Disorder of Pregnancy (HDP) [ Time Frame: From >20 weeks gestation until hospital discharge following delivery, up to 22 weeks ]

Central Contacts

Locations (16)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233
Akila Subramaniam, MD, MPH
[email protected]
Donna Campbell, PhD
[email protected]
205-996-6268
Cedars Sinai Medical CenterLos AngelesCalifornia90048
Kimberly Gregory, MD, MPH
Samia Saeb
[email protected]
Kimberly Gregory, MD, MPH (PRINCIPAL_INVESTIGATOR)
University of California, San FranciscoSan FranciscoCalifornia94158
Mary Norton, MD
[email protected]
(415) 476-4080
Nuriye Sahin-Hodoglugil, DrPH
[email protected]
Mary Norton, MD (PRINCIPAL_INVESTIGATOR)
Northwestern UniversityChicagoIllinois60611
Michelle Kominiarek, MD
[email protected]
Catherine Arguelles
[email protected]
Michelle Kominiarek, MD (PRINCIPAL_INVESTIGATOR)
Kiarri Kershaw, PhD, MPH (SUB_INVESTIGATOR)
University of MississippiJacksonMississippi39216
Rachel Morris, MD
[email protected]
Laura Coats
[email protected]
Rachel Morris, MD (PRINCIPAL_INVESTIGATOR)
University of New MexicoAlbuquerqueNew Mexico27710
Christina Yarrington, MD
[email protected]
Karen S Taylor
[email protected]
Christina Yarrington, MD (PRINCIPAL_INVESTIGATOR)
Columbia UniversityNew YorkNew York10032
Matthew Hoffman, MD
[email protected]
(646) 284-5360
Cassandra Almonte
[email protected]
Matthew Hoffman, MD (PRINCIPAL_INVESTIGATOR)
University of North Carolina, Chapel HillChapel HillNorth Carolina27514
Kim Boggess, MD
[email protected]
Kelly Clark
[email protected]
Kim Boggess, MD (PRINCIPAL_INVESTIGATOR)
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal MedicineColumbusOhio43210
Maged Costantine, MD, MBA
[email protected]
614-293-2222
Kara Rood, MD
[email protected]
614-293-8045
Kara Rood, MD (SUB_INVESTIGATOR)
Ann McAlearney, ScD, MS (SUB_INVESTIGATOR)
Anne Trinh, MPH (SUB_INVESTIGATOR)
University of Pittsburg MageePittsburghPennsylvania15213
Hyagriv Simhan, MD
[email protected]
Jeanette Boyce
[email protected]
Hyagriv Simhan, MD (PRINCIPAL_INVESTIGATOR)
Brown UniversityProvidenceRhode Island02905
William Grobman, MD, MBA
[email protected]
Angelica Demartino
[email protected]
(401) 274-1122
University of Texas, HoustonHoustonTexas77030
Baha Sibai, MD
[email protected]
Sunbola Ashimi, PhD
[email protected]
Baha Sibai, MD (PRINCIPAL_INVESTIGATOR)
University of UtahSalt Lake CityUtah84132
Torri Metz, MD
[email protected]
Amber Sowles, BSN, RN
[email protected]
801-585-5499
Inova HealthSystemFalls ChurchVirginia22042
Antonio Saad, MD
[email protected]
Michelle Cassidy, PhD, RN
[email protected]
703-776-4600
Eastern Virginia Medical School - Old Dominion UniversityNorfolkVirginia23501
George Saade, MD
[email protected]
Kristin Ayers
[email protected]
George Saade, MD (PRINCIPAL_INVESTIGATOR)
Medical College of WisconsinMilwaukeeWisconsin53226
Anna Palatnik, MD
[email protected]
Alyssa Hernandez, DO
[email protected]
414-955-2781

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