RecruitingPhase 4

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
14 Years to 35 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two daily doses of aspirin, 162 mg and 81 mg, to see which works better to prevent high blood pressure problems during pregnancy. It is for pregnant people at higher risk of these problems. The study also looks at what helps people take aspirin as directed.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a living pregnancy inside the womb, at 16 weeks and 6 days or earlier.
  • Be at least 14 years old and able to agree to join the study.
  • Have at least 1 high-risk factor OR at least 2 moderate-risk factors listed below.
  • High-risk factors include past preeclampsia (a serious pregnancy-related blood pressure problem), ongoing high blood pressure, diabetes from before pregnancy or found by qualifying tests before joining, twins, long-term kidney disease, or an illness where the immune system attacks the body, such as lupus.
  • Moderate-risk factors include no past birth at 20 weeks or later, obesity (body mass index of 30 or higher), age 35 or older at the due date, Black race, or low income.
  • Other moderate-risk factors include a past small or low-birth-weight baby, unexplained stillbirth, a placenta that separated too early, more than 10 years between pregnancies, a mother or sister with preeclampsia, or pregnancy through IVF (fertilization in a lab).
  • Not be taking aspirin now, OR be taking it for a pregnancy-related reason and meet the timing rules below.
  • If already taking aspirin for pregnancy, enter the assigned study group before 13 weeks, or enter at 13 weeks or later after starting aspirin within the past 2 weeks.

Who can't join

  • Be allergic to aspirin or have a condition that makes it unsafe, such as an active stomach ulcer, nasal growths called polyps, asthma caused by certain pain medicines, active stomach or bowel bleeding, G6PD enzyme deficiency, severe liver problems, a bleeding disorder, or past weight-loss surgery.
  • Use or plan to use aspirin during pregnancy for a reason not related to pregnancy, such as a past stroke or heart attack.
  • Be younger than 14, be held or detained against your will, or have a reduced ability to make decisions.
  • Have a scan suggesting a major birth defect, known or suspected extra or missing chromosomes in the baby, a baby that has died in the womb, or plans to end the pregnancy.
  • Be in another study that could affect this study's main result without approval from the lead researcher.
  • Plan to give birth outside a participating site where the study team cannot get your medical records.
  • Have twins sharing one fluid-filled sac, or be pregnant with 3 or more babies.
  • Have joined this study during an earlier pregnancy.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. live intrauterine gestation ≤16 6/7 weeks gestational age based on best clinical obstetric estimate, 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 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) 4. 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 5. 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). Exclusion Criteria: 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, history of bariatric surgery), 2. current or planned aspirin use in pregnancy for non-obstetrical indication (e.g., prior stroke/prior myocardial infraction), 3. age \< 14 years, 4. involuntarily confined or detained, 5. considered as having a diminished decision-making capacity, 6. obstetrical ultrasound suspicious for major congenital abnormality, known or suspected fetal aneuploidy, fetal demise, or planned pregnancy termination, 7. participation in another trial that affects the primary outcome, without prior approval of the PI, 8. plan to deliver at an outside participating site with inability to obtain medical records, 9. monoamniotic twin gestation because of the risk of fetal demise and preterm delivery, 10. participation in this trial in prior pregnancy, 11. triplet or higher order pregnancy.

Study sites (20)

AL

CA

IL

LA

MS

NC

NM

NY

OH

PA

RI

SC

TX

UT

VA

WI