NCT06468202 Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL
| NCT ID | NCT06468202 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Ohio State University |
| Condition | Hypertensive Disorders of Pregnancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 10,742 participants |
| Start Date | 2024-10-18 |
| Primary Completion | 2029-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 10,742 participants in total. It began in 2024-10-18 with a primary completion date of 2029-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Maged Costantine, MD, MBA
PRINCIPAL INVESTIGATOR
Ohio State University
Frequently Asked Questions
Who can join the NCT06468202 clinical trial?
This trial is open to female participants only, aged 14 Years or older, up to 35 Years, studying Hypertensive Disorders of Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06468202 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06468202 currently recruiting?
Yes, NCT06468202 is actively recruiting participants. Contact the research team at Maged.Costantine@osumc.edu for enrollment information.
Where is the NCT06468202 trial being conducted?
This trial is being conducted at Birmingham, United States, Los Angeles, United States, San Francisco, United States, Chicago, United States and 11 additional locations.
Who is sponsoring the NCT06468202 clinical trial?
NCT06468202 is sponsored by Ohio State University. The principal investigator is Maged Costantine, MD, MBA at Ohio State University. The trial plans to enroll 10,742 participants.