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Prevention study for Hypertensive Disorders of Pregnancy
Official title Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL
ClinicalTrials.gov ID: NCT06468202
What this study is testing
What is Aspirin 81 mg?
Aspirin 81 mg is an investigational medicine, being studied as a potential treatment for hypertensive disorders of pregnancy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 35, women only
You may be able to join 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...
- 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...
- patient not currently on aspirin OR patient on aspirin for obstetrical indications (e.g., related to IVF, or HDP) and: i- assigned by chance before...
You likely can't join if
- known allergy or hypersensitivity to aspirin or any medical condition where aspirin is contraindicated (e.g., active peptic ulcer disease, nasal...
- 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...
See the full eligibility criteria
- 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...
- 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...
- patient not currently on aspirin OR patient on aspirin for obstetrical indications (e.g., related to IVF, or HDP) and: i- assigned by chance before 130/7 weeks gestation, or ii- assigned by chance on or after 13 0/7...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Chicago, Illinois, United States
- Jackson, Mississippi, United States
- Albuquerque, New Mexico, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Columbus, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Providence, Rhode Island, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- Falls Church, Virginia, United States
- Norfolk, Virginia, United States
- Milwaukee, Wisconsin, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 14 years to 35 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Los Angeles, California, United States; San Francisco, California, United States; Chicago, Illinois, United States; Jackson, Mississippi, United States; Albuquerque, New Mexico, United States and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.