Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-27 @ 11:27 PM
Study NCT ID:
NCT04144660
Status:
COMPLETED
Last Update Posted:
2020-11-23
First Post:
2019-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"Treatment Use of ECMO In Pregnancy or Peripartum Patient."
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012770', 'term': 'Shock, Cardiogenic'}, {'id': 'D000099088', 'term': 'Peripartum Cardiomyopathy'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D011249', 'term': 'Pregnancy Complications, Cardiovascular'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015199', 'term': 'Extracorporeal Membrane Oxygenation'}], 'ancestors': [{'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D005112', 'term': 'Extracorporeal Circulation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-19', 'studyFirstSubmitDate': '2019-10-28', 'studyFirstSubmitQcDate': '2019-10-28', 'lastUpdatePostDateStruct': {'date': '2020-11-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Outcome of Mother', 'timeFrame': 'Time of diagnosis -Six Month Survival Rate', 'description': 'Describe clinical course of pregnant or recently postpartum patients with cardiogenic shock treated with ECMO, including the rate of neonate survival'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiogenic Shock', 'Peripartum Cardiomyopathy', 'Complication, Pregnancy']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to describe the use of ECMO (Extracorporeal Membrane Oxygenation) in the pregnant or peripartum patient.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women treated with ECMO while pregnant or immediately postpartum (within six months).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female\n2. Age 18 years or greater at the time of ECMO treatment.\n3. Pregnant or within 6 months post-partum at the time of ECMO cannulation\n\nExclusion Criteria:\n\n1. No history of pregnancy.\n2. No treatment with ECMO.'}, 'identificationModule': {'nctId': 'NCT04144660', 'briefTitle': '"Treatment Use of ECMO In Pregnancy or Peripartum Patient."', 'organization': {'class': 'OTHER', 'fullName': 'Medical College of Wisconsin'}, 'officialTitle': '"Treatment Use of ECMO In Pregnancy or Peripartum Patient."', 'orgStudyIdInfo': {'id': 'PRO00036221'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cardiogenic Shock Treated with ECMO', 'description': 'This cohort of participants required clinical intervention with ECMO for treatment of their index cardiogenic shock episode while pregnant or post delivery of their infant.', 'interventionNames': ['Device: Extracorporeal Membrane Oxygenation']}], 'interventions': [{'name': 'Extracorporeal Membrane Oxygenation', 'type': 'DEVICE', 'description': 'Use of ECMO for circulatory / hemodynamic support of peripartum of pregnant patients who developed cardiogenic shock.', 'armGroupLabels': ['Cardiogenic Shock Treated with ECMO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Sarah Thordsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical College of Wisconsin'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sarah Thordsen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical College of Wisconsin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor Cardiovascular Medicine', 'investigatorFullName': 'Sarah Thordsen', 'investigatorAffiliation': 'Medical College of Wisconsin'}}}}