What is the Purpose of this Study?
The purpose of this study is to compare 2 commonly used doses of aspirin to prevent hypertensive (high blood pressure) disorders of pregnancy (HDP) in women who are pregnant and at risk of having HDP. HDP includes conditions such as preeclampsia and gestational hypertension and is often diagnosed when a pregnant mother develops high blood pressure during the second half of pregnancy. These conditions often lead to an early delivery, which can then lead to a possible increased risk for health problems for both the baby and mother. Participants will be randomly assigned to 1 of 2 doses of aspirin; both doses are commonly prescribed by obstetric providers. Specifically, the study will assess whether 81 mg per day (1 tablet) compared to 162 mg per day (2 tablets) prevents more HDP and improves the health of the mother and baby. Researchers also aim to evaluate the factors that make it easier for mothers to take their aspirin correctly from the beginning of the study until the end. Participants will complete questionnaires and researchers will collect medical information about the mother and newborn baby. While aspirin is approved by the U.S. Food and Drug Administration (FDA), its use in this study to prevent HDP is experimental.
Eligibility
- 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
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
ASPIRIN Trial: Comparative effectiveness of two aspirin doses for prevention of hypertensive disorders of pregnancy