NCT06468202

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,742

participants targeted

Target at P75+ for phase_4

Timeline
45mo left

Started Oct 2024

Longer than P75 for phase_4

Geographic Reach
1 country

16 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
Oct 2024Feb 2030

First Submitted

Initial submission to the registry

June 12, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 21, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

October 18, 2024

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2030

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

4.2 years

First QC Date

June 12, 2024

Last Update Submit

April 28, 2026

Conditions

Hypertensive Disorders of PregnancyGestational HypertensionPreeclampsia

Keywords

Hypertensive disorders of pregnancyAspirin treatmentPregnancyPreeclampsia

Outcome Measures

Primary Outcomes (1)

  • Hypertensive Disorder of Pregnancy (HDP)

    HDP defined as preeclampsia or antepartum gHTN based on ACOG criteria

    From >20 weeks gestation until hospital discharge following delivery, up to 22 weeks

Secondary Outcomes (15)

  • Preeclampsia

    From >20 weeks gestation until hospital discharge following delivery, up to 22 weeks

  • Preterm preeclampsia

    From >20 weeks and ≤ 36 weeks 6 days, up to 17 weeks

  • Postpartum preeclampsia

    From delivery weeks till 6 weeks postpartum; 6 weeks

  • Gestational hypertension

    From >20 weeks until onset of labor, up to 22 weeks

  • Severe maternal morbidity

    From randomization up to 6 weeks postpartum, up to 48 weeks

  • +10 more secondary outcomes

Study Arms (2)

81 mg Aspirin

EXPERIMENTAL

Treatment A consisting of 81mg of aspirin (1 pill of 81mg \& 1 matching placebo) daily

Drug: Aspirin 81 mg

162 mg Aspirin

EXPERIMENTAL

Treatment B consisting of 162mg of aspirin (2 pills, each of 81mg) daily

Drug: Aspirin 162 mg

Interventions

Aspirin 81 mgDRUG

Participants will be assigned to 81mg Aspirin

81 mg Aspirin
Aspirin 162 mgDRUG

Participants will be assigned to 162mg Aspirin

162 mg Aspirin

Eligibility Criteria

Age14 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • known allergy or hypersensitivity to aspirin or any medical condition where aspirin is contraindicated (e.g., active peptic ulcer disease, nasal polyps, NSAID-induced asthma, active gastrointestinal bleeding, known G6PD deficiency, severe hepatic dysfunction, bleeding disorders, history of bariatric surgery),
  • current or planned aspirin use in pregnancy for non-obstetrical indication (e.g., prior stroke/prior myocardial infraction),
  • age \< 14 years,
  • involuntarily confined or detained,
  • considered as having a diminished decision-making capacity,
  • obstetrical ultrasound suspicious for major congenital abnormality, known or suspected fetal aneuploidy, fetal demise, or planned pregnancy termination,
  • participation in another trial that affects the primary outcome, without prior approval of the PI,
  • plan to deliver at an outside participating site with inability to obtain medical records,
  • monoamniotic twin gestation because of the risk of fetal demise and preterm delivery,
  • participation in this trial in prior pregnancy,
  • triplet or higher order pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

University of California, San Francisco

San Francisco, California, 94158, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

University of Mississippi

Jackson, Mississippi, 39216, United States

RECRUITING

University of New Mexico

Albuquerque, New Mexico, 27710, United States

RECRUITING

Columbia University

New York, New York, 10032, United States

RECRUITING

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27514, United States

RECRUITING

The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

Columbus, Ohio, 43210, United States

RECRUITING

University of Pittsburg Magee

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Brown University

Providence, Rhode Island, 02905, United States

RECRUITING

University of Texas, Houston

Houston, Texas, 77030, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84132, United States

RECRUITING

Inova HealthSystem

Falls Church, Virginia, 22042, United States

RECRUITING

Eastern Virginia Medical School - Old Dominion University

Norfolk, Virginia, 23501, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Pre-EclampsiaHypertension, Pregnancy-Induced

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Maged Costantine, MD, MBA

    Ohio State University

    PRINCIPAL INVESTIGATOR

  • Denise Sholtens, PhD

    Northwestern University Data Analysis and Coordinating Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maged Costantine, MD, MBA

CONTACT

614-293-2222Maged.Costantine@osumc.edu

Kara Rood, MD

CONTACT

614-293-8045Kara.Rood@osumc.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Neither participants, providers, investigators or outcome assessors will know to which of these groups participants are assigned. In case of an emergency, however, the study doctor can get this information.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A randomized double-blind, multicenter, comparative effectiveness trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MBA, Professor

Study Record Dates

First Submitted

June 12, 2024

First Posted

June 21, 2024

Study Start

October 18, 2024

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

February 1, 2030

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(16)