Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-04 @ 10:24 PM
Study NCT ID:
NCT06118957
Status:
COMPLETED
Last Update Posted:
2025-09-04
First Post:
2023-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Low Molecular Weight Heparin or no Treatment Following Cesarean Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D013923', 'term': 'Thromboembolism'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017984', 'term': 'Enoxaparin'}], 'ancestors': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'elizabeth.e.turner@hsc.utah.edu', 'phone': '8012018929', 'title': 'Elizabeth Turner, MPH, Senior Regulatory Coordinator', 'organization': 'University of Utah Obgyn'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Within 6 Weeks Postpartum', 'description': 'Complications by study group', 'eventGroups': [{'id': 'EG000', 'title': 'Enoxaparin', 'description': 'Participants will receive weight-based dosing of enoxaparin at 0.5 mg/kg rounded to the nearest 10 mg every 12 hours based on delivery admission weight. Participants will receive therapy for 14 days.\n\nEnoxaparin: Participants will receive weight-based dosing of enoxaparin at 0.5 mg/kg rounded to the nearest 10 mg every 12 hours based on delivery admission weight. Participants will receive therapy for 14 days.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 4, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'No Treatment-', 'description': 'Participants will receive no enoxaparin treatment.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 3, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Blood in Breast Milk', 'notes': 'Patient concern for blood in breast milk. Clinician examination negative and concern resolved.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'cholelithiasis', 'notes': 'Presentation to emergency department with right upper quadrant pain. Labs and ultrasound obtained consistent with cholelithiasis. Discharged with oral pain regimen.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'notes': 'Superficial surgical site infection with cellulitis, treated with oral antibiotics.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Uterine Rupture with broad ligament hematoma', 'notes': 'uterine rupture with broad ligament expanding hematoma requiring return to surgery on post day # for evacuation of hemoperitoneum. Patient enrolled in trial but not yet received therapy or no therapy per randomization (at clinician discretion).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgical site infection', 'notes': 'Surgical site infection with abscess requiring intravenous antibiotics and incision drainage.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Superficial incision separation', 'notes': 'Superficial incision separation (2 mm by clinician examination).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pancreatitis', 'notes': 'Presentation to emergency department with right upper quadrant pain. Labs and imaging obtained consistent with acute idiopathic pancreatitis without necrosis or infection. Conservatively managed.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rate of Eligible Individuals Enrolled and Retained Through Full Study Procedures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '694', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Eligible Participants', 'description': 'Eligible Participants for Enrollment in the Study'}], 'classes': [{'title': '# of eligible patients', 'categories': [{'measurements': [{'value': '694', 'groupId': 'OG000'}]}]}, {'title': 'Approach rate (proportion of eligible patients approached)', 'categories': [{'measurements': [{'value': '611', 'groupId': 'OG000'}]}]}, {'title': 'Enrollment rate (proportion of eligible patients enrolled)', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}]}]}, {'title': 'Retention rate (proportion enrolled completing study)', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'A pilot randomized controlled trial of low molecular weight heparin or no treatment following cesarean delivery NCT06118957 July 30, 2025 6 weeks', 'description': 'Feasibility as defined by ≥35% enrollment of eligible individuals and retention ≥85% of enrolled individuals through all study procedures', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Venous Thromboembolism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enoxaparin', 'description': 'Participants will receive weight-based dosing of enoxaparin at 0.5 mg/kg rounded to the nearest 10 mg every 12 hours based on delivery admission weight. Participants will receive therapy for 14 days.\n\nEnoxaparin: Participants will receive weight-based dosing of enoxaparin at 0.5 mg/kg rounded to the nearest 10 mg every 12 hours based on delivery admission weight. Participants will receive therapy for 14 days.'}, {'id': 'OG001', 'title': 'No Treatment', 'description': 'Participants will receive no enoxaparin treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 Weeks', 'description': 'Objectively (by imaging) diagnosed deep vein thrombosis or pulmonary embolism', 'unitOfMeasure': '# of venous thromboembolism events', 'reportingStatus': 'POSTED', 'populationDescription': 'There were no reported incidents for venous thromboembolism'}, {'type': 'SECONDARY', 'title': 'Rate of Wound Hematoma or Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Enoxaparin', 'description': 'Participants will receive weight-based dosing of enoxaparin at 0.5 mg/kg rounded to the nearest 10 mg every 12 hours based on delivery admission weight. Participants will receive therapy for 14 days'}, {'id': 'OG001', 'title': 'No Intervention: No Treatment', 'description': 'Participants will receive no enoxaparin treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 Weeks', 'description': 'Clinically diagnosed', 'unitOfMeasure': '# of reported wound hematoma events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Bleeding Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Enoxaparin', 'description': 'Participants will receive weight-based dosing of enoxaparin at 0.5 mg/kg rounded to the nearest 10 mg every 12 hours based on delivery admission weight. Participants will receive therapy for 14 days'}, {'id': 'OG001', 'title': 'No Intervention: No Treatment', 'description': 'Participants will receive no enoxaparin treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 Weeks', 'description': 'Clinically diagnosed as readmission to hospital for bleeding or delayed postpartum hemorrhage (\\>24 hours after delivery)', 'unitOfMeasure': '# of reported bleeding complication even', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental: Enoxaparin', 'description': 'Participants will receive weight-based dosing of enoxaparin at 0.5 mg/kg rounded to the nearest 10 mg every 12 hours based on delivery admission weight. Participants will receive therapy for 14 days'}, {'id': 'FG001', 'title': 'No Intervention: No Treatment', 'description': 'Participants will receive no enoxaparin treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}, {'value': '547', 'groupId': 'BG001'}, {'value': '611', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Enrolled', 'description': 'Participants who enrolled in the study'}, {'id': 'BG001', 'title': 'Declined', 'description': 'Patients who declined participation in the study'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.95', 'spread': '5.5', 'groupId': 'BG000'}, {'value': '31.37', 'spread': '5.7', 'groupId': 'BG001'}, {'value': '31.32', 'spread': '5.66', 'groupId': 'BG002'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years of age', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '547', 'groupId': 'BG001'}, {'value': '611', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '315', 'groupId': 'BG001'}, {'value': '355', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Rate of approach and enrollment of all screened eligible patients over the six-month study period by month'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-09-03', 'size': 284296, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_002.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2025-08-26T12:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-29', 'studyFirstSubmitDate': '2023-10-31', 'resultsFirstSubmitDate': '2025-06-23', 'studyFirstSubmitQcDate': '2023-10-31', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-29', 'studyFirstPostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Eligible Individuals Enrolled and Retained Through Full Study Procedures', 'timeFrame': 'A pilot randomized controlled trial of low molecular weight heparin or no treatment following cesarean delivery NCT06118957 July 30, 2025 6 weeks', 'description': 'Feasibility as defined by ≥35% enrollment of eligible individuals and retention ≥85% of enrolled individuals through all study procedures'}], 'secondaryOutcomes': [{'measure': 'Rate of Venous Thromboembolism', 'timeFrame': '6 Weeks', 'description': 'Objectively (by imaging) diagnosed deep vein thrombosis or pulmonary embolism'}, {'measure': 'Rate of Wound Hematoma or Infection', 'timeFrame': '6 Weeks', 'description': 'Clinically diagnosed'}, {'measure': 'Rate of Bleeding Complications', 'timeFrame': '6 Weeks', 'description': 'Clinically diagnosed as readmission to hospital for bleeding or delayed postpartum hemorrhage (\\>24 hours after delivery)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thromboembolism', 'Enoxaparin', 'Cesarean delivery'], 'conditions': ['Thromboembolism']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the feasibility of randomizing individuals to low molecular weight heparin (enoxaparin) or no treatment following cesarean delivery. The investigators hypothesize that among eligible individuals, at least 35% will enroll, undergo randomization, and complete the allocated treatment group.', 'detailedDescription': 'Venous thromboembolism (VTE) is a major contributor to maternal morbidity and mortality. The first two weeks postpartum are the highest risk period for VTE during pregnancy and the postpartum period. Cesarean delivery is a known risk factor for VTE. In the United States, postpartum prophylaxis with low molecular weight heparin (e.g., enoxaparin) is commonly used during the first 10-14 days after delivery. Enoxaparin has not been demonstrated as an effective intervention to prevent postpartum VTE after cesarean delivery. Before larger scale studies may be completed, a better understanding of ability to randomize individuals to this intervention is needed. This study aims to evaluate the feasibility of randomizing individuals after cesarean delivery to the receipt of enoxaparin prophylaxis or no treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cesarean delivery at the University of Utah Health\n\nExclusion Criteria:\n\n* Contraindication to anticoagulation\n* Plan for therapeutic anticoagulation\n* Known renal dysfunction (creatinine clearance \\<30mL/minute)\n* History of venous thromboembolism\n* High risk thrombophilia\n* Receipt of antepartum anticoagulation for \\>2 weeks'}, 'identificationModule': {'nctId': 'NCT06118957', 'briefTitle': 'Low Molecular Weight Heparin or no Treatment Following Cesarean Delivery', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'A Pilot Randomized Controlled Trial of Low Molecular Weight Heparin or no Treatment Following Cesarean Delivery', 'orgStudyIdInfo': {'id': 'IRB_00167480'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enoxaparin', 'description': 'Participants will receive weight-based dosing of enoxaparin at 0.5 mg/kg rounded to the nearest 10 mg every 12 hours based on delivery admission weight. Participants will receive therapy for 14 days.', 'interventionNames': ['Drug: Enoxaparin']}, {'type': 'NO_INTERVENTION', 'label': 'No treatment', 'description': 'Participants will receive no enoxaparin treatment.'}], 'interventions': [{'name': 'Enoxaparin', 'type': 'DRUG', 'description': 'Participants will receive weight-based dosing of enoxaparin at 0.5 mg/kg rounded to the nearest 10 mg every 12 hours based on delivery admission weight. Participants will receive therapy for 14 days.', 'armGroupLabels': ['Enoxaparin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Ann Bruno, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor Obstetrics And Gynecology', 'investigatorFullName': 'Ann Bruno', 'investigatorAffiliation': 'University of Utah'}}}}