[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06468202":3,"trial-entities:NCT06468202":394,"trial-summary:NCT06468202":394},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":45,"secondary_outcomes":50,"sex":105,"minimum_age":106,"maximum_age":107,"healthy_volunteers":108,"eligibility_criteria":109,"std_ages":113,"locations":116,"central_contacts":384,"overall_officials":387,"references":392,"see_also_links":393},"NCT06468202","Pro00079100","Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL","Comparative Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL","RECRUITING","2030-02-01","2026-04","2026-05-04","2024-10-18","Ohio State University","OTHER",true,"The overall goal of this large, pragmatic, comparative effectiveness trial is to test the hypothesis that among at-risk individuals, 162 mg\u002Fday aspirin is superior to 81 mg\u002Fday 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.\n\nThe overall goal of this large, pragmatic, comparative effectiveness trial is to test the hypothesis that among at-risk individuals, 162 mg\u002Fday aspirin is superior to 81 mg\u002Fday 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:\n\nSpecific 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.\n\nSpecific 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.\n\nSpecific 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.",[19,20,21],"Hypertensive Disorders of Pregnancy","Preeclampsia","Gestational Hypertension",[23,24,25,20],"Hypertensive disorders of pregnancy","Aspirin treatment","Pregnancy","INTERVENTIONAL","PREVENTION",[29],"PHASE4",{"count":31,"type":32},10742,"ESTIMATED",[34,40],{"type":35,"name":36,"description":37,"armGroupLabels":38},"DRUG","Aspirin 81 mg","Participants will be assigned to 81mg Aspirin",[39],"81 mg Aspirin",{"type":35,"name":41,"description":42,"armGroupLabels":43},"Aspirin 162 mg","Participants will be assigned to 162mg Aspirin",[44],"162 mg Aspirin",[46],{"measure":47,"description":48,"timeFrame":49},"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",[51,53,57,61,65,69,72,76,79,83,87,90,94,98,102],{"measure":20,"description":52,"timeFrame":49},"preeclampsia based on ACOG criteria",{"measure":54,"description":55,"timeFrame":56},"Preterm preeclampsia","Preeclampsia per ACOG criteria with delivery \\\u003C 37 weeks'","From >20 weeks and ≤ 36 weeks 6 days, up to 17 weeks",{"measure":58,"description":59,"timeFrame":60},"Postpartum preeclampsia","Postpartum preeclampsia per ACOG criteria","From delivery weeks till 6 weeks postpartum; 6 weeks",{"measure":62,"description":63,"timeFrame":64},"Gestational hypertension","Gestational hypertension per ACOG criteria","From >20 weeks until onset of labor, up to 22 weeks",{"measure":66,"description":67,"timeFrame":68},"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",{"measure":70,"description":71,"timeFrame":68},"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)",{"measure":73,"description":74,"timeFrame":75},"Bleeding complications (maternal)","Antepartum bleeding and Placental abruption","From randomization till delivery up to 36 weeks, up to 36 weeks",{"measure":73,"description":77,"timeFrame":78},"Postpartum hemorrhage","From delivery till hospital discharge, up to 1 week",{"measure":80,"description":81,"timeFrame":82},"Adherence to aspirin","pill count","From randomization until last day of medication intake, up to 42 weeks",{"measure":84,"description":85,"timeFrame":86},"Preterm birth","Delivery \\\u003C37 weeks","At time of delivery",{"measure":88,"description":89,"timeFrame":86},"Gestational age at birth","Gestational age in weeks at time of delivery",{"measure":91,"description":92,"timeFrame":93},"Core offspring\u002Fneonatal outcomes","Composite and individual neonatal outcomes (Stillbirth, SGA, Neonatal mortality, Neonatal seizures, Admission to NICU, Respiratory support)","up to 6 weeks post-delivery",{"measure":95,"description":96,"timeFrame":97},"Rate of SGA","Rate of birthweight \\\u003C10th percentile","At time of birth",{"measure":99,"description":100,"timeFrame":101},"Bleeding complications (neonatal)","Any neonatal intraventricular or intracranial hemorrhage","Up to 6 weeks post-delivery",{"measure":103,"description":104,"timeFrame":101},"Complications of prematurity and neonatal safety outcomes","Composite of RDS, Grade III-IV IVH, PVL, Stage 2\u002F3 NEC, BPD, Stage III or higher ROP, or early onset sepsis","FEMALE","14 Years","35 Years",false,{"inclusion":110,"exclusion":111,"raw_text":112},[],[],"Inclusion Criteria:\n\n1. live intrauterine gestation ≤16 6\u002F7 weeks gestational age based on best clinical obstetric estimate,\n2. age 14 years or older and able to provide informed consent,\n3. 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)\n4. 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\u002Fm2 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\n5. patient not currently on aspirin OR patient on aspirin for obstetrical indications (e.g., related to IVF, or HDP) and: i- randomized before 130\u002F7 weeks gestation, or ii- randomized on or after 13 0\u002F7 weeks gestation and started aspirin within 2 weeks prior to randomization (e.g., aspirin started for HDP prevention at 12 0\u002F7 weeks and patient randomized at 13 2\u002F7 weeks).\n\nExclusion Criteria:\n\n1. 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),\n2. current or planned aspirin use in pregnancy for non-obstetrical indication (e.g., prior stroke\u002Fprior myocardial infraction),\n3. age \\\u003C 14 years,\n4. involuntarily confined or detained,\n5. considered as having a diminished decision-making capacity,\n6. obstetrical ultrasound suspicious for major congenital abnormality, known or suspected fetal aneuploidy, fetal demise, or planned pregnancy termination,\n7. participation in another trial that affects the primary outcome, without prior approval of the PI,\n8. plan to deliver at an outside participating site with inability to obtain medical records,\n9. monoamniotic twin gestation because of the risk of fetal demise and preterm delivery,\n10. participation in this trial in prior pregnancy,\n11. triplet or higher order pregnancy.",[114,115],"CHILD","ADULT",[117,135,151,167,186,202,218,234,250,272,288,305,321,337,353,368],{"facility":118,"status":8,"city":119,"state":120,"zip":121,"country":122,"contacts":123,"geoPoint":132},"University of Alabama at Birmingham","Birmingham","Alabama","35233","United States",[124,128],{"name":125,"role":126,"email":127},"Akila Subramaniam, MD, MPH","CONTACT","asubramaniam@uabmc.edu",{"name":129,"role":126,"phone":130,"email":131},"Donna Campbell, PhD","205-996-6268","dcampbell@uabmc.edu",{"lat":133,"lon":134},33.52066,-86.80249,{"facility":136,"status":8,"city":137,"state":138,"zip":139,"country":122,"contacts":140,"geoPoint":148},"Cedars Sinai Medical Center","Los Angeles","California","90048",[141,143,146],{"name":142,"role":126},"Kimberly Gregory, MD, MPH",{"name":144,"role":126,"email":145},"Samia Saeb","Samia.Saeb@cshs.org",{"name":142,"role":147},"PRINCIPAL_INVESTIGATOR",{"lat":149,"lon":150},34.05223,-118.24368,{"facility":152,"status":8,"city":153,"state":138,"zip":154,"country":122,"contacts":155,"geoPoint":164},"University of California, San Francisco","San Francisco","94158",[156,160,163],{"name":157,"role":126,"phone":158,"email":159},"Mary Norton, MD","(415) 476-4080","Mary.Norton@ucsf.edu",{"name":161,"role":126,"email":162},"Nuriye Sahin-Hodoglugil, DrPH","nuriye.sahin-hodoglugil@ucsf.edu",{"name":157,"role":147},{"lat":165,"lon":166},37.77493,-122.41942,{"facility":168,"status":8,"city":169,"state":170,"zip":171,"country":122,"contacts":172,"geoPoint":183},"Northwestern University","Chicago","Illinois","60611",[173,176,179,180],{"name":174,"role":126,"email":175},"Michelle Kominiarek, MD","Michelle.Kominiarek@nm.org",{"name":177,"role":126,"email":178},"Catherine Arguelles","catherine.marek@nm.org",{"name":174,"role":147},{"name":181,"role":182},"Kiarri Kershaw, PhD, MPH","SUB_INVESTIGATOR",{"lat":184,"lon":185},41.85003,-87.65005,{"facility":187,"status":8,"city":188,"state":189,"zip":190,"country":122,"contacts":191,"geoPoint":199},"University of Mississippi","Jackson","Mississippi","39216",[192,195,198],{"name":193,"role":126,"email":194},"Rachel Morris, MD","morris@umc.edu",{"name":196,"role":126,"email":197},"Laura Coats","Lcoats@umc.edu",{"name":193,"role":147},{"lat":200,"lon":201},32.29876,-90.18481,{"facility":203,"status":8,"city":204,"state":205,"zip":206,"country":122,"contacts":207,"geoPoint":215},"University of New Mexico","Albuquerque","New Mexico","27710",[208,211,214],{"name":209,"role":126,"email":210},"Christina Yarrington, MD","CYarrington@salud.unm.edu",{"name":212,"role":126,"email":213},"Karen S Taylor","kataylor@salud.unm.edu",{"name":209,"role":147},{"lat":216,"lon":217},35.08449,-106.65114,{"facility":219,"status":8,"city":220,"state":220,"zip":221,"country":122,"contacts":222,"geoPoint":231},"Columbia University","New York","10032",[223,227,230],{"name":224,"role":126,"phone":225,"email":226},"Matthew Hoffman, MD","(646) 284-5360","mh4795@cumc.columbia.edu",{"name":228,"role":126,"email":229},"Cassandra Almonte","ca2344@cumc.columbia.edu",{"name":224,"role":147},{"lat":232,"lon":233},40.71427,-74.00597,{"facility":235,"status":8,"city":236,"state":237,"zip":238,"country":122,"contacts":239,"geoPoint":247},"University of North Carolina, Chapel Hill","Chapel Hill","North Carolina","27514",[240,243,246],{"name":241,"role":126,"email":242},"Kim Boggess, MD","kim_boggess@med.unc.edu",{"name":244,"role":126,"email":245},"Kelly Clark","Kelly_Clark@med.unc.edu",{"name":241,"role":147},{"lat":248,"lon":249},35.9132,-79.05584,{"facility":251,"status":8,"city":252,"state":253,"zip":254,"country":122,"contacts":255,"geoPoint":269},"The Ohio State University Wexner Medical Center OB\u002FGYN Maternal and Fetal Medicine","Columbus","Ohio","43210",[256,260,264,265,267],{"name":257,"role":126,"phone":258,"email":259},"Maged Costantine, MD, MBA","614-293-2222","Maged.Costantine@osumc.edu",{"name":261,"role":126,"phone":262,"email":263},"Kara Rood, MD","614-293-8045","Kara.Rood@osumc.edu",{"name":261,"role":182},{"name":266,"role":182},"Ann McAlearney, ScD, MS",{"name":268,"role":182},"Anne Trinh, MPH",{"lat":270,"lon":271},39.96118,-82.99879,{"facility":273,"status":8,"city":274,"state":275,"zip":276,"country":122,"contacts":277,"geoPoint":285},"University of Pittsburg Magee","Pittsburgh","Pennsylvania","15213",[278,281,284],{"name":279,"role":126,"email":280},"Hyagriv Simhan, MD","simhhn@upmc.edu",{"name":282,"role":126,"email":283},"Jeanette Boyce","tessje@upmc.edu",{"name":279,"role":147},{"lat":286,"lon":287},40.44062,-79.99589,{"facility":289,"status":8,"city":290,"state":291,"zip":292,"country":122,"contacts":293,"geoPoint":302},"Brown University","Providence","Rhode Island","02905",[294,297],{"name":295,"role":126,"email":296},"William Grobman, MD, MBA","WGrobman@KentRI.org",{"name":298,"role":126,"phone":299,"phoneExt":300,"email":301},"Angelica Demartino","(401) 274-1122","48521","AMDemartino@CareNE.org",{"lat":303,"lon":304},41.82399,-71.41283,{"facility":306,"status":8,"city":307,"state":308,"zip":309,"country":122,"contacts":310,"geoPoint":318},"University of Texas, Houston","Houston","Texas","77030",[311,314,317],{"name":312,"role":126,"email":313},"Baha Sibai, MD","Baha.M.Sibai@uth.tmc.edu",{"name":315,"role":126,"email":316},"Sunbola Ashimi, PhD","Sunbola.S.Ashimi@uth.tmc.edu",{"name":312,"role":147},{"lat":319,"lon":320},29.76328,-95.36327,{"facility":322,"status":8,"city":323,"state":324,"zip":325,"country":122,"contacts":326,"geoPoint":334},"University of Utah","Salt Lake City","Utah","84132",[327,330],{"name":328,"role":126,"email":329},"Torri Metz, MD","Torri.Metz@hsc.utah.edu",{"name":331,"role":126,"phone":332,"email":333},"Amber Sowles, BSN, RN","801-585-5499","Amber.Sowles@hsc.utah.edu",{"lat":335,"lon":336},40.76078,-111.89105,{"facility":338,"status":8,"city":339,"state":340,"zip":341,"country":122,"contacts":342,"geoPoint":350},"Inova HealthSystem","Falls Church","Virginia","22042",[343,346],{"name":344,"role":126,"email":345},"Antonio Saad, MD","Antonio.Saad@inova.org",{"name":347,"role":126,"phone":348,"email":349},"Michelle Cassidy, PhD, RN","703-776-4600","Michelle.Cassidy@inova.org",{"lat":351,"lon":352},38.88233,-77.17109,{"facility":354,"status":8,"city":355,"state":340,"zip":356,"country":122,"contacts":357,"geoPoint":365},"Eastern Virginia Medical School - Old Dominion University","Norfolk","23501",[358,361,364],{"name":359,"role":126,"email":360},"George Saade, MD","SaadeGR@EVMS.edu",{"name":362,"role":126,"email":363},"Kristin Ayers","ayerskl@evms.edu",{"name":359,"role":147},{"lat":366,"lon":367},36.84681,-76.28522,{"facility":369,"status":8,"city":370,"state":371,"zip":372,"country":122,"contacts":373,"geoPoint":381},"Medical College of Wisconsin","Milwaukee","Wisconsin","53226",[374,377],{"name":375,"role":126,"email":376},"Anna Palatnik, MD","apalatnik@mcw.edu",{"name":378,"role":126,"phone":379,"email":380},"Alyssa Hernandez, DO","414-955-2781","alyhernandez@mcw.edu",{"lat":382,"lon":383},43.0389,-87.90647,[385,386],{"name":257,"role":126,"phone":258,"email":259},{"name":261,"role":126,"phone":262,"email":263},[388,389],{"name":257,"affiliation":13,"role":147},{"name":390,"affiliation":391,"role":147},"Denise Sholtens, PhD","Northwestern University Data Analysis and Coordinating Center",[],[],null]