Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL
NCT Number: NCT06468202
Acronym: ASPIRIN
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Hypertensive Disorders of Pregnancy|Preeclampsia|Gestational Hypertension
Interventions: DRUG: Aspirin 81 mg|DRUG: Aspirin 162 mg
Sponsor: Ohio State University
Collaborators: Patient-Centered Outcomes Research Institute|Northwestern University|Preeclampsia Foundation
Sex: FEMALE
Age: CHILD, ADULT
Enrollment: 10742
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-12-01
Completion Date: 2030-02-01
Locations: Cedars Sinai Medical Center, Los Angeles, California, 90048, United States|University of California, San Francisco, San Francisco, California, 94158, United States|Northwestern University, Chicago, Illinois, 60611, United States|University of Mississippi, Jackson, Mississippi, 39216, United States|University of New Mexico, Albuquerque, New Mexico, 27710, United States|Columbia University, New York, New York, 10032, United States|University of North Carolina, Chapel Hill, Chapel Hill, North Carolina, 27514, United States|The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine, Columbus, Ohio, 43210, United States|University of Pittsburg Magee, Pittsburgh, Pennsylvania, 15213, United States|University of Texas, Houston, Houston, Texas, 77030, United States|Eastern Virginia Medical School, Norfolk, Virginia, 23501, United States

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.

Primary Outcome Measures: Hypertensive Disorder of Pregnancy (HDP), HDP defined as preeclampsia or antepartum gHTN based on ACOG criteria, From >20 weeks gestation until hospital discharge following delivery, up to 22 weeks
Secondary Outcome Measures: Preeclampsia, preeclampsia based on ACOG criteria, From >20 weeks gestation until hospital discharge following delivery, up to 22 weeks|Preterm preeclampsia, Preeclampsia per ACOG criteria with delivery \< 37 weeks', From >20 weeks and ≤ 36 weeks 6 days, up to 17 weeks|Postpartum preeclampsia, Postpartum preeclampsia per ACOG criteria, From delivery weeks till 6 weeks postpartum; 6 weeks|Gestational hypertension, Gestational hypertension per ACOG criteria, From >20 weeks until onset of labor, up to 22 weeks|Severe maternal morbidity, Need for intensive care, maternal admission to a hospital within the first 42 days postpartum for obstetric complications, or blood product transfusion, From randomization up to 6 weeks postpartum, up to 48 weeks|Core preeclampsia outcomes, Composite and individual maternal outcomes (Mortality, Eclampsia, Stroke, Cortical blindness, Retinal detachment, Pulmonary edema, Acute kidney injury, Liver capsule hematoma, Placental abruption, Postpartum hemorrhage, Elevated liver enzymes, Thrombocytopenia, ICU admission, Mechanical ventilation), From randomization up to 6 weeks postpartum, up to 48 weeks|Bleeding complications (maternal), Antepartum bleeding and Placental abruption, From randomization till delivery up to 36 weeks, up to 36 weeks|Bleeding complications (maternal), Postpartum hemorrhage, From delivery till hospital discharge, up to 1 week|Adherence to aspirin, pill count, From randomization until last day of medication intake, up to 42 weeks|Preterm birth, Delivery \<37 weeks, At time of delivery|Gestational age at birth, Gestational age in weeks at time of delivery, At time of delivery|Core offspring/neonatal outcomes, Composite and individual neonatal outcomes (Stillbirth, SGA, Neonatal mortality, Neonatal seizures, Admission to NICU, Respiratory support), up to 6 weeks post-delivery|Rate of SGA, Rate of birthweight \<10th percentile, At time of birth|Bleeding complications (neonatal), Any neonatal intraventricular or intracranial hemorrhage, Up to 6 weeks post-delivery|Complications of prematurity and neonatal safety outcomes, Composite of RDS, Grade III-IV IVH, PVL, Stage 2/3 NEC, BPD, Stage III or higher ROP, or early onset sepsis, Up to 6 weeks post-delivery