Summary

Eligibility
for females ages 14-35 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Mary Norton, MD
Headshot of Mary Norton
Mary Norton

Description

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.

Official Title

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

Details

Hypertensive disorders of pregnancy (HDP), such as preeclampsia (PE) and gestational hypertension (gHTN), occur in ~15% of pregnant individuals, disproportionately affect self-identified non-Hispanic Black individuals (with the understanding that race is a socially defined construct and the inequity is related to social determinants of health), are increasing in frequency, and are associated with short- and long-term maternal and neonatal morbidities and mortality. There are currently no available therapeutics to treat individuals with HDP; thus, developing interventions for the prevention of HDP is of substantial public health significance. The U.S. Preventive Services Task Force (USPSTF) and other professional societies recommend or endorse the use of aspirin for prevention of HDP in individuals at high or moderate risk. However, there is great uncertainty regarding optimal dosing, whether there is heterogeneity of effectiveness of aspirin in reducing the risk of HDP among different populations, and what factors are associated with adherence.

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 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. The trial will achieve the following specific aims:

Specific Aim 1: To compare the frequency of HDP (primary outcome), as well as other important secondary outcomes (gHTN, PE, preterm PE, PE-related adverse outcomes, aspirin-related safety outcomes, and patient-reported outcomes related to maternal health, pregnancy, and childbirth experiences) between the two aspirin treatment arms.

Specific Aim 2: To compare the gestational age at birth and the frequency of adverse perinatal outcomes (preterm birth, perinatal death, small-for-gestational-age birth, neonatal intensive care unit admission, and complications of prematurity), as well as patient-reported outcomes related to maternal-infant bonding between the two aspirin treatment arms.

Specific Aim 3: To use quantitative and qualitative analyses to elucidate facilitators and barriers associated with adherence to aspirin therapy in at-risk individuals during pregnancy in order to facilitate future implementation.

Keywords

Hypertensive Disorders of Pregnancy, Preeclampsia, Gestational Hypertension, Aspirin treatment, Pregnancy, Toxemia, Pre-Eclampsia, Pregnancy-Induced Hypertension, Pregnancy Complications, Hypertension, Aspirin, Aspirin 81 mg, Aspirin 162 mg

Eligibility

You can join if…

Open to females ages 14-35

  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:

    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 elevated 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, lupus)

  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).

You CAN'T join if...

  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.

Locations

  • UCSF not yet accepting patients
    San Francisco California 94158 United States
  • Cedars Sinai Medical Center not yet accepting patients
    Los Angeles California 90048 United States
  • The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine accepting new patients
    Columbus Ohio 43210 United States

Lead Scientist at UCSF

  • Mary Norton, MD
    Mary E. Norton is a perinatologist and clinical geneticist at UCSF Medical Center's Prenatal Diagnostic Center. She primarily cares for pregnant women who have a fetus with a birth defect or genetic disorder or are at risk for such a condition.

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Ohio State University
ID
NCT06468202
Phase
Phase 4 research study
Study Type
Interventional
Participants
Expecting 10742 study participants
Last Updated