Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-02-20 @ 12:35 PM
Study NCT ID:
NCT06468202
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2024-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Neither participants, providers, investigators or outcome assessors will know to which of these groups participants are assigned. In case of an emergency, however, the study doctor can get this information.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized double-blind, multicenter, comparative effectiveness trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10742}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2030-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-22', 'studyFirstSubmitDate': '2024-06-12', 'studyFirstSubmitQcDate': '2024-06-15', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hypertensive Disorder of Pregnancy (HDP)', 'timeFrame': 'From >20 weeks gestation until hospital discharge following delivery, up to 22 weeks', 'description': 'HDP defined as preeclampsia or antepartum gHTN based on ACOG criteria'}], 'secondaryOutcomes': [{'measure': 'Preeclampsia', 'timeFrame': 'From >20 weeks gestation until hospital discharge following delivery, up to 22 weeks', 'description': 'preeclampsia based on ACOG criteria'}, {'measure': 'Preterm preeclampsia', 'timeFrame': 'From >20 weeks and ≤ 36 weeks 6 days, up to 17 weeks', 'description': "Preeclampsia per ACOG criteria with delivery \\< 37 weeks'"}, {'measure': 'Postpartum preeclampsia', 'timeFrame': 'From delivery weeks till 6 weeks postpartum; 6 weeks', 'description': 'Postpartum preeclampsia per ACOG criteria'}, {'measure': 'Gestational hypertension', 'timeFrame': 'From >20 weeks until onset of labor, up to 22 weeks', 'description': 'Gestational hypertension per ACOG criteria'}, {'measure': 'Severe maternal morbidity', 'timeFrame': 'From randomization up to 6 weeks postpartum, up to 48 weeks', 'description': 'Need for intensive care, maternal admission to a hospital within the first 42 days postpartum for obstetric complications, or blood product transfusion'}, {'measure': 'Core preeclampsia outcomes', 'timeFrame': 'From randomization up to 6 weeks postpartum, up to 48 weeks', 'description': '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': 'Bleeding complications (maternal)', 'timeFrame': 'From randomization till delivery up to 36 weeks, up to 36 weeks', 'description': 'Antepartum bleeding and Placental abruption'}, {'measure': 'Bleeding complications (maternal)', 'timeFrame': 'From delivery till hospital discharge, up to 1 week', 'description': 'Postpartum hemorrhage'}, {'measure': 'Adherence to aspirin', 'timeFrame': 'From randomization until last day of medication intake, up to 42 weeks', 'description': 'pill count'}, {'measure': 'Preterm birth', 'timeFrame': 'At time of delivery', 'description': 'Delivery \\<37 weeks'}, {'measure': 'Gestational age at birth', 'timeFrame': 'At time of delivery', 'description': 'Gestational age in weeks at time of delivery'}, {'measure': 'Core offspring/neonatal outcomes', 'timeFrame': 'up to 6 weeks post-delivery', 'description': 'Composite and individual neonatal outcomes (Stillbirth, SGA, Neonatal mortality, Neonatal seizures, Admission to NICU, Respiratory support)'}, {'measure': 'Rate of SGA', 'timeFrame': 'At time of birth', 'description': 'Rate of birthweight \\<10th percentile'}, {'measure': 'Bleeding complications (neonatal)', 'timeFrame': 'Up to 6 weeks post-delivery', 'description': 'Any neonatal intraventricular or intracranial hemorrhage'}, {'measure': 'Complications of prematurity and neonatal safety outcomes', 'timeFrame': 'Up to 6 weeks post-delivery', 'description': 'Composite of RDS, Grade III-IV IVH, PVL, Stage 2/3 NEC, BPD, Stage III or higher ROP, or early onset sepsis'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypertensive disorders of pregnancy', 'Aspirin treatment', 'Pregnancy', 'Preeclampsia'], 'conditions': ['Hypertensive Disorders of Pregnancy', 'Preeclampsia', 'Gestational Hypertension']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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/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:\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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '14 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. live intrauterine gestation ≤16 6/7 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/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\n5. patient not currently on aspirin OR patient on aspirin for obstetrical indications (e.g., related to IVF, or HDP) and: i- randomized before 130/7 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).\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/prior myocardial infraction),\n3. age \\< 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.'}, 'identificationModule': {'nctId': 'NCT06468202', 'acronym': 'ASPIRIN', 'briefTitle': 'Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Comparative Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL', 'orgStudyIdInfo': {'id': 'Pro00079100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '81 mg Aspirin', 'description': 'Treatment A consisting of 81mg of aspirin (1 pill of 81mg \\& 1 matching placebo) daily', 'interventionNames': ['Drug: Aspirin 81 mg']}, {'type': 'EXPERIMENTAL', 'label': '162 mg Aspirin', 'description': 'Treatment B consisting of 162mg of aspirin (2 pills, each of 81mg) daily', 'interventionNames': ['Drug: Aspirin 162 mg']}], 'interventions': [{'name': 'Aspirin 81 mg', 'type': 'DRUG', 'description': 'Participants will be assigned to 81mg Aspirin', 'armGroupLabels': ['81 mg Aspirin']}, {'name': 'Aspirin 162 mg', 'type': 'DRUG', 'description': 'Participants will be assigned to 162mg Aspirin', 'armGroupLabels': ['162 mg Aspirin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Akila Subramaniam, MD, MPH', 'role': 'CONTACT', 'email': 'asubramaniam@uabmc.edu'}, {'name': 'Donna Campbell, PhD', 'role': 'CONTACT', 'email': 'dcampbell@uabmc.edu', 'phone': '205-996-6268'}], 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kimberly Gregory, MD, MPH', 'role': 'CONTACT'}, {'name': 'Samia Saeb', 'role': 'CONTACT', 'email': 'Samia.Saeb@cshs.org'}, {'name': 'Kimberly Gregory, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mary Norton, MD', 'role': 'CONTACT', 'email': 'Mary.Norton@ucsf.edu', 'phone': '(415) 476-4080'}, {'name': 'Nuriye Sahin-Hodoglugil, DrPH', 'role': 'CONTACT', 'email': 'nuriye.sahin-hodoglugil@ucsf.edu'}, {'name': 'Mary Norton, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michelle Kominiarek, MD', 'role': 'CONTACT', 'email': 'Michelle.Kominiarek@nm.org'}, {'name': 'Catherine Arguelles', 'role': 'CONTACT', 'email': 'catherine.marek@nm.org'}, {'name': 'Michelle Kominiarek, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Kiarri Kershaw, PhD, MPH', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rachel Morris, MD', 'role': 'CONTACT', 'email': 'morris@umc.edu'}, {'name': 'Laura Coats', 'role': 'CONTACT', 'email': 'Lcoats@umc.edu'}, {'name': 'Rachel Morris, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Mississippi', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '27710', 'city': 'Albuquerque', 'state': 'New Mexico', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christina Yarrington, MD', 'role': 'CONTACT', 'email': 'CYarrington@salud.unm.edu'}, {'name': 'Karen S Taylor', 'role': 'CONTACT', 'email': 'kataylor@salud.unm.edu'}, {'name': 'Christina Yarrington, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Uma Reddy, MD', 'role': 'CONTACT', 'email': 'ur2137@cumc.columbia.edu', 'phone': '(212) 305-7334'}, {'name': 'Cassandra Almonte', 'role': 'CONTACT', 'email': 'ca2344@cumc.columbia.edu'}, {'name': 'Uma Reddy, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kim Boggess, MD', 'role': 'CONTACT', 'email': 'kim_boggess@med.unc.edu'}, {'name': 'Kelly Clark', 'role': 'CONTACT', 'email': 'Kelly_Clark@med.unc.edu'}, {'name': 'Kim Boggess, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of North Carolina, Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maged Costantine, MD, MBA', 'role': 'CONTACT', 'email': 'Maged.Costantine@osumc.edu', 'phone': '614-293-2222'}, {'name': 'Kara Rood, MD', 'role': 'CONTACT', 'email': 'Kara.Rood@osumc.edu', 'phone': '614-293-8045'}, {'name': 'Kara Rood, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ann McAlearney, ScD, MS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Anne Trinh, MPH', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Hyagriv Simhan, MD', 'role': 'CONTACT', 'email': 'simhhn@upmc.edu'}, {'name': 'Jeanette Boyce', 'role': 'CONTACT', 'email': 'tessje@upmc.edu'}, {'name': 'Hyagriv Simhan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Pittsburg Magee', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '02905', 'city': 'Providence', 'state': 'Rhode Island', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'William Grobman, MD, MBA', 'role': 'CONTACT', 'email': 'WGrobman@KentRI.org'}, {'name': 'Angelica Demartino', 'role': 'CONTACT', 'email': 'AMDemartino@CareNE.org', 'phone': '(401) 274-1122', 'phoneExt': '48521'}], 'facility': 'Brown University', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Baha Sibai, MD', 'role': 'CONTACT', 'email': 'Baha.M.Sibai@uth.tmc.edu'}, {'name': 'Sunbola Ashimi, PhD', 'role': 'CONTACT', 'email': 'Sunbola.S.Ashimi@uth.tmc.edu'}, {'name': 'Baha Sibai, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Texas, Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Torri Metz, MD', 'role': 'CONTACT', 'email': 'Torri.Metz@hsc.utah.edu'}, {'name': 'Amber Sowles, BSN, RN', 'role': 'CONTACT', 'email': 'Amber.Sowles@hsc.utah.edu', 'phone': '801-585-5499'}], 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '22042', 'city': 'Falls Church', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Antonio Saad, MD', 'role': 'CONTACT', 'email': 'Antonio.Saad@inova.org'}, {'name': 'Michelle Cassidy, PhD, RN', 'role': 'CONTACT', 'email': 'Michelle.Cassidy@inova.org', 'phone': '703-776-4600'}], 'facility': 'Inova HealthSystem', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}, {'zip': '23501', 'city': 'Norfolk', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'George Saade, MD', 'role': 'CONTACT', 'email': 'SaadeGR@EVMS.edu'}, {'name': 'Kristin Ayers', 'role': 'CONTACT', 'email': 'ayerskl@evms.edu'}, {'name': 'George Saade, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Eastern Virginia Medical School - Old Dominion University', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anna Palatnik, MD', 'role': 'CONTACT', 'email': 'apalatnik@mcw.edu'}, {'name': 'Alyssa Hernandez, DO', 'role': 'CONTACT', 'email': 'alyhernandez@mcw.edu', 'phone': '414-955-2781'}], 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'centralContacts': [{'name': 'Maged Costantine, MD, MBA', 'role': 'CONTACT', 'email': 'Maged.Costantine@osumc.edu', 'phone': '614-293-2222'}, {'name': 'Kara Rood, MD', 'role': 'CONTACT', 'email': 'Kara.Rood@osumc.edu', 'phone': '614-293-8045'}], 'overallOfficials': [{'name': 'Maged Costantine, MD, MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}, {'name': 'Denise Sholtens, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University Data Analysis and Coordinating Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}, {'name': 'Northwestern University', 'class': 'OTHER'}, {'name': 'Preeclampsia Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, MBA, Professor', 'investigatorFullName': 'Maged Costantine', 'investigatorAffiliation': 'Ohio State University'}}}}