A Phase 4 interventional study of Aspirin 81 mg and Aspirin 162 mg in Hypertensive Disorders of Pregnancy, Preeclampsia and Gestational Hypertension, sponsored by Ohio State University. Recruiting at 16 sites in United States. Open to female participants aged 14 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by Ohio State University · Phase 4, Interventional, and Prevention
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.
Hypertensive disorders of pregnancy (HDP), such as preeclampsia (PE) and gestational hypertension (gHTN), occur in \~15% of pregnant individuals, disproportionately affect self-identified non-Hispanic Black individuals (with the understanding that race is a socially defined construct and the inequity is related to social determinants of health), are increasing in frequency, and are associated with short- and long-term maternal and neonatal morbidities and mortality. There are currently no available therapeutics to treat individuals with HDP; thus, developing interventions for the prevention of HDP is of substantial public health significance. The U.S. Preventive Services Task Force (USPSTF) and other professional societies recommend or endorse the use of aspirin for prevention of HDP in individuals at high or moderate risk. However, there is great uncertainty regarding optimal dosing, whether there is heterogeneity of effectiveness of aspirin in reducing the risk of HDP among different populations, and what factors are associated with adherence.
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 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. The trial will achieve the following specific aims:
Specific Aim 1: To compare the frequency of HDP (primary outcome), as well as other important secondary outcomes (gHTN, PE, preterm PE, PE-related adverse outcomes, aspirin-related safety outcomes, and patient-reported outcomes related to maternal health, pregnancy, and childbirth experiences) between the two aspirin treatment arms.
Specific Aim 2: To compare the gestational age at birth and the frequency of adverse perinatal outcomes (preterm birth, perinatal death, small-for-gestational-age birth, neonatal intensive care unit admission, and complications of prematurity), as well as patient-reported outcomes related to maternal-infant bonding between the two aspirin treatment arms.
Specific Aim 3: To use quantitative and qualitative analyses to elucidate facilitators and barriers associated with adherence to aspirin therapy in at-risk individuals during pregnancy in order to facilitate future implementation.
882 studies on the registry are indexed under Pre-Eclampsia; 237 are open to participants now.
This study's planned enrollment of 10,742 is above the median of 110 across 468 interventional studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →Ohio State University is the lead sponsor of 640 studies on the registry; 144 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 45 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment A consisting of 81mg of aspirin (1 pill of 81mg \& 1 matching placebo) daily
Drug: Aspirin 81 mg
Treatment B consisting of 162mg of aspirin (2 pills, each of 81mg) daily
Drug: Aspirin 162 mg
Participants will be assigned to 81mg Aspirin
Participants will be assigned to 162mg Aspirin
Hypertensive Disorder of Pregnancy (HDP)
HDP defined as preeclampsia or antepartum gHTN based on ACOG criteria
Time frame: From >20 weeks gestation until hospital discharge following delivery, up to 22 weeks
Preeclampsia
preeclampsia based on ACOG criteria
Time frame: From >20 weeks gestation until hospital discharge following delivery, up to 22 weeks
Preterm preeclampsia
Preeclampsia per ACOG criteria with delivery \< 37 weeks'
Time frame: From >20 weeks and ≤ 36 weeks 6 days, up to 17 weeks
Postpartum preeclampsia
Postpartum preeclampsia per ACOG criteria
Time frame: From delivery weeks till 6 weeks postpartum; 6 weeks
Gestational hypertension
Gestational hypertension per ACOG criteria
Time frame: 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
Time frame: 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)
Time frame: From randomization up to 6 weeks postpartum, up to 48 weeks
Bleeding complications (maternal)
Antepartum bleeding and Placental abruption
Time frame: From randomization till delivery up to 36 weeks, up to 36 weeks
Bleeding complications (maternal)
Postpartum hemorrhage
Time frame: From delivery till hospital discharge, up to 1 week
Adherence to aspirin
pill count
Time frame: From randomization until last day of medication intake, up to 42 weeks
Preterm birth
Delivery \<37 weeks
Time frame: At time of delivery
Gestational age at birth
Gestational age in weeks at time of delivery
Time frame: At time of delivery
Core offspring/neonatal outcomes
Composite and individual neonatal outcomes (Stillbirth, SGA, Neonatal mortality, Neonatal seizures, Admission to NICU, Respiratory support)
Time frame: up to 6 weeks post-delivery
Rate of SGA
Rate of birthweight \<10th percentile
Time frame: At time of birth
Bleeding complications (neonatal)
Any neonatal intraventricular or intracranial hemorrhage
Time frame: 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
Time frame: Up to 6 weeks post-delivery
Plan to share: No
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