RECRUITING

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

Conditions

Hypertensive Disorders of Pregnancy Preeclampsia Gestational Hypertension Aspirin treatment Pregnancy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-10-18

Study Completion:2030-02-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06468202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years to 35 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
1. Live intrauterine gestation \<16 6/7 weeks gestational age based on best obstetric estimate by the American College of Obstetricians and Gynecologists (ACOG) criteria, 2. Age 14 years or older and able to provide informed consent, 3. At least one of the following high-risk criteria: 4. Or two or more moderate-risk criteria for HDP (per The U.S. Preventive Services Task Force (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 enrollment) iii) age ≥35 years (at time of expected estimated due date) iv) sociodemographic characteristics (Black race, government-assisted insurance) v) 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).	1. 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), 2. Planned aspirin use in pregnancy for non-obstetrical indication (e.g., prior stroke/prior myocardial infraction), 3. Current aspirin use for obstetrical indications (e.g., related to IVF, or HDP) with inability to enroll and randomize in this trial before 13 0/7 weeks gestation (e.g., aspirin use started at 3 weeks gestation with continued use and approached for participation in this trial at 15 weeks' gestation), or more than 2 weeks of using aspirin if it was started \>13 0/7 weeks (e.g., aspirin started for HDP prevention at 13 0/7 weeks but patient approached for participation at 15 2/7 weeks), 4. Age \< 14 years, 5. Involuntarily confined or detained, 6. Considered as having a diminished decision-making capacity, 7. Obstetrical ultrasound suspicious for major congenital abnormality, known or suspected fetal aneuploidy, fetal demise, or planned pregnancy termination, 8. Participation in another trial that affects the primary outcome, without prior approval of the PI, 9. Plan to delivery outside participating site with inability to obtain medical records, 10. Monoamniotic twin gestation because of the risk of fetal demise and preterm delivery, 11. Participation in this trial in prior pregnancy, 12. Triplet or higher order pregnancy.

Inclusion Criteria

Exclusion Criteria

1. Live intrauterine gestation \<16 6/7 weeks gestational age based on best obstetric estimate by the American College of Obstetricians and Gynecologists (ACOG) criteria,
2. Age 14 years or older and able to provide informed consent,
3. At least one of the following high-risk criteria:
4. Or two or more moderate-risk criteria for HDP (per The U.S. Preventive Services Task Force (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 enrollment) iii) age ≥35 years (at time of expected estimated due date) iv) sociodemographic characteristics (Black race, government-assisted insurance) v) 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).

1. 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),
2. Planned aspirin use in pregnancy for non-obstetrical indication (e.g., prior stroke/prior myocardial infraction),
3. Current aspirin use for obstetrical indications (e.g., related to IVF, or HDP) with inability to enroll and randomize in this trial before 13 0/7 weeks gestation (e.g., aspirin use started at 3 weeks gestation with continued use and approached for participation in this trial at 15 weeks' gestation), or more than 2 weeks of using aspirin if it was started \>13 0/7 weeks (e.g., aspirin started for HDP prevention at 13 0/7 weeks but patient approached for participation at 15 2/7 weeks),
4. Age \< 14 years,
5. Involuntarily confined or detained,
6. Considered as having a diminished decision-making capacity,
7. Obstetrical ultrasound suspicious for major congenital abnormality, known or suspected fetal aneuploidy, fetal demise, or planned pregnancy termination,
8. Participation in another trial that affects the primary outcome, without prior approval of the PI,
9. Plan to delivery outside participating site with inability to obtain medical records,
10. Monoamniotic twin gestation because of the risk of fetal demise and preterm delivery,
11. Participation in this trial in prior pregnancy,
12. Triplet or higher order pregnancy.

Contacts and Locations

Study Contact

Maged Costantine, MD, MBA

CONTACT

614-293-2222

Maged.Costantine@osumc.edu

Kara Rood, MD

CONTACT

614-293-8045

Kara.Rood@osumc.edu

Principal Investigator

Maged Costantine, MD, MBA

PRINCIPAL_INVESTIGATOR

Ohio State University

Denise Sholtens, PhD

PRINCIPAL_INVESTIGATOR

Northwestern University Data Analysis and Coordinating Center

Study Locations (Sites)

Cedars Sinai Medical Center

Los Angeles, California, 90048

United States

University of California, San Francisco

San Francisco, California, 94158

United States

Northwestern University

Chicago, Illinois, 60611

United States

University of Mississippi

Jackson, Mississippi, 39216

United States

University of New Mexico

Albuquerque, New Mexico, 27710

United States

Columbia University

New York, New York, 10032

United States

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27514

United States

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

Columbus, Ohio, 43210

United States

University of Pittsburg Magee

Pittsburg, Pennsylvania, 15213

United States

University of Texas, Houston

Houston, Texas, 77030

United States

Eastern Virginia Medical School

Norfolk, Virginia, 23501

United States

Collaborators and Investigators

Sponsor: Ohio State University

Maged Costantine, MD, MBA, PRINCIPAL_INVESTIGATOR, Ohio State University
Denise Sholtens, PhD, PRINCIPAL_INVESTIGATOR, Northwestern University Data Analysis and Coordinating Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-18

Study Completion Date2030-02-01

Study Record Updates

Study Start Date2024-10-18

Study Completion Date2030-02-01

Terms related to this study

Keywords Provided by Researchers

Hypertensive disorders of pregnancy
Aspirin treatment
Pregnancy
Preeclampsia

Additional Relevant MeSH Terms

Hypertensive Disorders of Pregnancy
Preeclampsia
Gestational Hypertension