Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 4:24 PM
Study NCT ID:
NCT03961360
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2019-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effectiveness of Higher Aspirin Dosing for Prevention of Preeclampsia in High Risk Obese Gravida
Sponsor:
Organization:
Raw JSON
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'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'farah.h.amro@uth.tmc.edu', 'phone': '713-500-6421', 'title': 'Farah Amro, MD', 'organization': 'The University of Texas Health Science Center at Houston'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From enrollment (12 to 20.6 weeks gestational age) to 6 weeks post-partum', 'eventGroups': [{'id': 'EG000', 'title': '162 mg/Day Aspirin', 'description': 'Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia', 'otherNumAtRisk': 110, 'deathsNumAtRisk': 110, 'otherNumAffected': 51, 'seriousNumAtRisk': 110, 'deathsNumAffected': 0, 'seriousNumAffected': 24}, {'id': 'EG001', 'title': '81 mg/Day Aspirin', 'description': 'Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia', 'otherNumAtRisk': 110, 'deathsNumAtRisk': 110, 'otherNumAffected': 61, 'seriousNumAtRisk': 110, 'deathsNumAffected': 0, 'seriousNumAffected': 19}], 'otherEvents': [{'term': 'Preeclampsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 41}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gestational hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 20}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Necrotizing Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Placenta Abruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 3}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Postpartum hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 9}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Maternal blood transfusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 6}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fetal Heart Defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Kidney Malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Preeclampsia Diagnosis With Severe Features Based on Clinician Diagnosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '162 mg/Day Aspirin', 'description': 'Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia'}, {'id': 'OG001', 'title': '81 mg/Day Aspirin', 'description': 'Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3-7 months', 'description': 'based on American College Obstetrics and Gynecology (ACOG) guidelines', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maternal Outcomes- Number of Participants Who Delivered Due to Preeclampsia With Severe Features', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '162 mg/Day Aspirin', 'description': 'Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia'}, {'id': 'OG001', 'title': '81 mg/Day Aspirin', 'description': 'Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'less than 37 weeks gestational age (GA)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maternal Outcomes-Number of Participants With Gestational Hypertension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '162 mg/Day Aspirin', 'description': 'Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia'}, {'id': 'OG001', 'title': '81 mg/Day Aspirin', 'description': 'Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3-7 months', 'description': 'development of hypertension anytime during pregnancy based on ACOG guidelines', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maternal Outcomes- Number of Participants With Placenta Abruption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '162 mg/Day Aspirin', 'description': 'Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia'}, {'id': 'OG001', 'title': '81 mg/Day Aspirin', 'description': 'Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 day', 'description': 'Placental abruption occurs when the placenta separates from the inner wall of the uterus before birth. As assessed by treating OBGYN', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maternal Outcomes- Number of Participants With Eclampsia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '162 mg/Day Aspirin', 'description': 'Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia'}, {'id': 'OG001', 'title': '81 mg/Day Aspirin', 'description': 'Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '20 weeks', 'description': 'onset of seizures (convulsions) in a woman with pre-eclampsia per ACOG guidelines', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maternal Outcomes- Number of Participants With HELLP Syndrome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '162 mg/Day Aspirin', 'description': 'Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia'}, {'id': 'OG001', 'title': '81 mg/Day Aspirin', 'description': 'Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 weeks', 'description': 'group of symptoms that occur in pregnant women who have: hemolysis(H): (the breakdown of red blood cells)elevated liver enzymes (EL). low platelet (LP) count. Assessed by ACOG guidelines and measured in urine and blood samples', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maternal Outcomes- Number of Participants With Postpartum Hemorrhage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '162 mg/Day Aspirin', 'description': 'Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia'}, {'id': 'OG001', 'title': '81 mg/Day Aspirin', 'description': 'Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1-24 hrs post delivery', 'description': 'excessive bleeding following the birth of a baby', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maternal Outcomes- Number of Participants With Other Maternal Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '162 mg/Day Aspirin', 'description': 'Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia'}, {'id': 'OG001', 'title': '81 mg/Day Aspirin', 'description': 'Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'during labor to 24 hrs post delivery', 'description': 'any other bleeding associated with birth not otherwise categorized', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maternal Outcomes- Number of Participants That Required Blood Transfusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '162 mg/Day Aspirin', 'description': 'Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia'}, {'id': 'OG001', 'title': '81 mg/Day Aspirin', 'description': 'Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'during delivery', 'description': 'peripartum', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Neonatal Outcome- Gestational Age at Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '162 mg/Day Aspirin', 'description': 'Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia'}, {'id': 'OG001', 'title': '81 mg/Day Aspirin', 'description': 'Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia'}], 'classes': [{'categories': [{'measurements': [{'value': '36.30', 'groupId': 'OG000', 'lowerLimit': '34.40', 'upperLimit': '37.40'}, {'value': '37.20', 'groupId': 'OG001', 'lowerLimit': '35.10', 'upperLimit': '38.20'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'at delivery', 'unitOfMeasure': 'weeks', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Neonatal Outcomes-Delivery at < 37 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '162 mg/Day Aspirin', 'description': 'Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia'}, {'id': 'OG001', 'title': '81 mg/Day Aspirin', 'description': 'Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at delivery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Neonatal Outcomes-Apgar Score < 5 at 5 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '162 mg/Day Aspirin', 'description': 'Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia'}, {'id': 'OG001', 'title': '81 mg/Day Aspirin', 'description': 'Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 minutes post delivery', 'description': 'The Apgar score is determined by evaluating the newborn baby on each of five criteria (appearance, pulse, grimace, activity, respiration) on a scale from zero to two, then summing the five values obtained. The total score ranges from zero to 10. A higher score indicates a better outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Neonatal Outcome-Small for Gestational Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '162 mg/Day Aspirin', 'description': 'Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia'}, {'id': 'OG001', 'title': '81 mg/Day Aspirin', 'description': 'Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at delivery', 'description': "Small for gestational age (SGA) means that a fetus or an infant is smaller or less developed than normal for the baby's sex and gestational age. Small for gestational age (SGA) is defined as a birth weight that is below the 10th percentile.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Neonatal Outcome-Neonatal Intensive Care Unit (NICU) Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '162 mg/Day Aspirin', 'description': 'Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia'}, {'id': 'OG001', 'title': '81 mg/Day Aspirin', 'description': 'Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '17'}, {'value': '10.5', 'groupId': 'OG001', 'lowerLimit': '3.75', 'upperLimit': '21.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from birth until discharge from NICU (about 1 to 4 weeks)', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Neonatal Outcome- Number of Participants With Intraventricular Hemorrhage Grade III-IV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '162 mg/Day Aspirin', 'description': 'Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia'}, {'id': 'OG001', 'title': '81 mg/Day Aspirin', 'description': 'Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from birth until discharge from NICU (about 1 to 4 weeks)', 'description': 'bleeding inside or around the ventricles in the brain.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Neonatal Outcome-Number of Participants With Bronchopulmonary Dysplasia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '162 mg/Day Aspirin', 'description': 'Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia'}, {'id': 'OG001', 'title': '81 mg/Day Aspirin', 'description': 'Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from birth until discharge from NICU (about 1 to 4 weeks)', 'description': 'chronic lung disease that affects newborns (mostly premature) and infants.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Neonatal Outcome-Number of Participants With Necrotizing Enterocolitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '162 mg/Day Aspirin', 'description': 'Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia'}, {'id': 'OG001', 'title': '81 mg/Day Aspirin', 'description': 'Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from birth until discharge from NICU (about 1 to 4 weeks)', 'description': 'medical condition where a portion of the bowel dies', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '162 mg/Day Aspirin', 'description': 'Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia'}, {'id': 'FG001', 'title': '81 mg/Day Aspirin', 'description': 'Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}, {'groupId': 'FG001', 'numSubjects': '110'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '102'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '162 mg/Day Aspirin', 'description': 'Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia'}, {'id': 'BG001', 'title': '81 mg/Day Aspirin', 'description': 'Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000', 'lowerLimit': '26', 'upperLimit': '34'}, {'value': '29', 'groupId': 'BG001', 'lowerLimit': '25', 'upperLimit': '33'}, {'value': '29', 'groupId': 'BG002', 'lowerLimit': '25', 'upperLimit': '34'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'African American', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}, {'title': 'Hispanic/Latina', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Unknown or not reported', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Insurance Type', 'classes': [{'categories': [{'title': 'Private', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Government assisted (Medicaid, Medicare or other federal or state funded assistance program)', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}]}, {'title': 'Self pay', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gestational age at enrollment', 'classes': [{'categories': [{'measurements': [{'value': '15.9', 'groupId': 'BG000', 'lowerLimit': '13.6', 'upperLimit': '17.6'}, {'value': '15.6', 'groupId': 'BG001', 'lowerLimit': '13.6', 'upperLimit': '17.7'}, {'value': '15.64', 'groupId': 'BG002', 'lowerLimit': '13.57', 'upperLimit': '17.71'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000', 'lowerLimit': '33', 'upperLimit': '43'}, {'value': '38', 'groupId': 'BG001', 'lowerLimit': '34', 'upperLimit': '44'}, {'value': '37.88', 'groupId': 'BG002', 'lowerLimit': '33.60', 'upperLimit': '43.73'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Number of Participants who are Nulliparous', 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants with Systemic Lupus Erythematosus', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants who use tobacco during pregnancy', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of preeclampsia in prior pregnancy', 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of participants with Type 1 diabetes', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of participants with type 2 diabetes', 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of participants diagnosed with gestational diabetes before 20 weeks', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of participants enrolled prior to 16 weeks', 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of participants on aspirin prior to enrollment', 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-03-08', 'size': 935790, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-04-09T13:34', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-10', 'studyFirstSubmitDate': '2019-04-16', 'resultsFirstSubmitDate': '2024-04-10', 'studyFirstSubmitQcDate': '2019-05-21', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-10', 'studyFirstPostDateStruct': {'date': '2019-05-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Preeclampsia Diagnosis With Severe Features Based on Clinician Diagnosis', 'timeFrame': '3-7 months', 'description': 'based on American College Obstetrics and Gynecology (ACOG) guidelines'}], 'secondaryOutcomes': [{'measure': 'Maternal Outcomes- Number of Participants Who Delivered Due to Preeclampsia With Severe Features', 'timeFrame': 'less than 37 weeks gestational age (GA)'}, {'measure': 'Maternal Outcomes-Number of Participants With Gestational Hypertension', 'timeFrame': '3-7 months', 'description': 'development of hypertension anytime during pregnancy based on ACOG guidelines'}, {'measure': 'Maternal Outcomes- Number of Participants With Placenta Abruption', 'timeFrame': '1 day', 'description': 'Placental abruption occurs when the placenta separates from the inner wall of the uterus before birth. As assessed by treating OBGYN'}, {'measure': 'Maternal Outcomes- Number of Participants With Eclampsia', 'timeFrame': '20 weeks', 'description': 'onset of seizures (convulsions) in a woman with pre-eclampsia per ACOG guidelines'}, {'measure': 'Maternal Outcomes- Number of Participants With HELLP Syndrome', 'timeFrame': '4 weeks', 'description': 'group of symptoms that occur in pregnant women who have: hemolysis(H): (the breakdown of red blood cells)elevated liver enzymes (EL). low platelet (LP) count. Assessed by ACOG guidelines and measured in urine and blood samples'}, {'measure': 'Maternal Outcomes- Number of Participants With Postpartum Hemorrhage', 'timeFrame': '1-24 hrs post delivery', 'description': 'excessive bleeding following the birth of a baby'}, {'measure': 'Maternal Outcomes- Number of Participants With Other Maternal Bleeding', 'timeFrame': 'during labor to 24 hrs post delivery', 'description': 'any other bleeding associated with birth not otherwise categorized'}, {'measure': 'Maternal Outcomes- Number of Participants That Required Blood Transfusion', 'timeFrame': 'during delivery', 'description': 'peripartum'}, {'measure': 'Neonatal Outcome- Gestational Age at Delivery', 'timeFrame': 'at delivery'}, {'measure': 'Neonatal Outcomes-Delivery at < 37 Weeks', 'timeFrame': 'at delivery'}, {'measure': 'Neonatal Outcomes-Apgar Score < 5 at 5 Minutes', 'timeFrame': '5 minutes post delivery', 'description': 'The Apgar score is determined by evaluating the newborn baby on each of five criteria (appearance, pulse, grimace, activity, respiration) on a scale from zero to two, then summing the five values obtained. The total score ranges from zero to 10. A higher score indicates a better outcome.'}, {'measure': 'Neonatal Outcome-Small for Gestational Age', 'timeFrame': 'at delivery', 'description': "Small for gestational age (SGA) means that a fetus or an infant is smaller or less developed than normal for the baby's sex and gestational age. Small for gestational age (SGA) is defined as a birth weight that is below the 10th percentile."}, {'measure': 'Neonatal Outcome-Neonatal Intensive Care Unit (NICU) Length of Stay', 'timeFrame': 'from birth until discharge from NICU (about 1 to 4 weeks)'}, {'measure': 'Neonatal Outcome- Number of Participants With Intraventricular Hemorrhage Grade III-IV', 'timeFrame': 'from birth until discharge from NICU (about 1 to 4 weeks)', 'description': 'bleeding inside or around the ventricles in the brain.'}, {'measure': 'Neonatal Outcome-Number of Participants With Bronchopulmonary Dysplasia', 'timeFrame': 'from birth until discharge from NICU (about 1 to 4 weeks)', 'description': 'chronic lung disease that affects newborns (mostly premature) and infants.'}, {'measure': 'Neonatal Outcome-Number of Participants With Necrotizing Enterocolitis', 'timeFrame': 'from birth until discharge from NICU (about 1 to 4 weeks)', 'description': 'medical condition where a portion of the bowel dies'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pre-Eclampsia', 'Hypertension in Pregnancy', 'Obesity']}, 'descriptionModule': {'briefSummary': 'To compare the incidence of preeclampsia in obese pregnant women (BMI greater than 30) with a singleton gestation at less than 20 weeks and either a history of preeclampsia in a prior pregnancy or stage I hypertension or pre-gestational diabetes who are randomized to either 81mg/day aspirin or 162mg/day aspirin.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* A singleton gestation at less than 20 weeks at time of enrollment, with a BMI greater than or equal to 30 and one of the following:\n\n 1\\. History of preeclampsia in a prior pregnancy\n* Diagnosis will be obtained by review of records, and if unavailable then patient history. Preeclampsia diagnosis may be made in antepartum or postpartum period.\n\nOR 2. At least stage I hypertension during pregnancy\n\n* Stage I hypertension is defined as a systolic blood pressure between 130- 139 mm Hg or diastolic blood pressure between 80-89 mm Hg21\n* This blood pressure criteria is met regardless of medication usage\n* The patient must have a blood pressure reading ≥ 130-139/80-89 mm Hg at least during 1 clinic visit during the current pregnancy; before or at time of enrollment\n\nOR\n\n3\\. Pre-gestational diabetes\n\n* Type 1 and Type 2 diabetics are included\n* Gestational diabetes mellitus diagnosed prior to 20 weeks gestational age will also be included\n\nExclusion Criteria\n\n* Known allergy/prior adverse reaction/any medical condition where aspirin is contraindicated\n* Already on aspirin prior to pregnancy\n* Baseline renal Disease\n* Baseline proteinuria identified at time of enrollment, defined as urine analysis with 3+ protein, or urine protein to creatinine ratio ≥ 0.3\n* Systemic Lupus Erythematosus\n* Seizure disorder on medications\n* HIV positive status\n* Known major fetal anomalies\n* Multifetal gestation'}, 'identificationModule': {'nctId': 'NCT03961360', 'acronym': 'ASPREO', 'briefTitle': 'Effectiveness of Higher Aspirin Dosing for Prevention of Preeclampsia in High Risk Obese Gravida', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Effectiveness of Higher Aspirin Dosing for Prevention of Preeclampsia in High Risk Obese Gravida: An Open Label, Comparative Effectiveness, Randomized Controlled Trial (ASPREO Trial)', 'orgStudyIdInfo': {'id': 'HSC-MS-18-1073'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '162 mg/day Aspirin', 'interventionNames': ['Drug: Aspirin 162 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': '81 mg/day Aspirin', 'interventionNames': ['Drug: Aspirin 81 mg']}], 'interventions': [{'name': 'Aspirin 81 mg', 'type': 'DRUG', 'description': 'Low dose aspirin was initially reported as having a beneficial effect at preeclampsia', 'armGroupLabels': ['81 mg/day Aspirin']}, {'name': 'Aspirin 162 mg', 'type': 'DRUG', 'description': 'Low dose aspirin was initially reported as having a beneficial effect at preeclampsia', 'armGroupLabels': ['162 mg/day Aspirin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'farah Amro, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Health Science Center of Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Fellow OBGYN', 'investigatorFullName': 'Farah Hassan Amro', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}