Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-02-23 @ 11:35 AM
Study NCT ID:
NCT01497756
Status:
COMPLETED
Last Update Posted:
2020-02-26
First Post:
2011-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Feasibility Trial of the Circumferential Abdominal Pelvic Pressure Device (CAPP)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006473', 'term': 'Postpartum Hemorrhage'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'markhauswald@gmail.com', 'phone': '505-269-6699', 'title': 'Mark Hauswald MD', 'organization': 'uNewMexico'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'CAPP Application', 'description': 'Patients in whom device is used', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Usage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CAPP Application', 'description': 'Patients in whom device is used'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Eight months', 'description': 'Number of patients on whom CAPP is used', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Entire number of participants'}, {'type': 'SECONDARY', 'title': 'Side Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CAPP Application', 'description': 'Patients in whom device is used'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Eight months', 'description': 'Any recorded complications', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CAPP Application', 'description': 'Patients in whom device is used'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'CAPP Application', 'description': 'Patients in whom device is used'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': 'NA', 'comment': 'DOB was not solicited. All subjects were legal adults and in emergency situations.', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': 'NA', 'comment': 'DOB was not solicited. All subjects were legal adults and in emergency situations.', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': 'NA', 'comment': 'No subjects were 65 or older since such patients are unable to become pregnant.', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'DOB was not solicited. All subjects were legal adults and in emergency situations.', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-25', 'studyFirstSubmitDate': '2011-12-20', 'resultsFirstSubmitDate': '2012-07-02', 'studyFirstSubmitQcDate': '2011-12-21', 'lastUpdatePostDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-08-17', 'studyFirstPostDateStruct': {'date': '2011-12-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Usage', 'timeFrame': 'Eight months', 'description': 'Number of patients on whom CAPP is used'}], 'secondaryOutcomes': [{'measure': 'Side Effects', 'timeFrame': 'Eight months', 'description': 'Any recorded complications'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Postpartum Hemorrhage']}, 'descriptionModule': {'briefSummary': 'A group of midwives and obstetric nurses have been trained to use circumferential abdominal pelvic pressure (CAPP) to treat postpartum hemorrhage. As part of the training follow up any use of a CAPP device will be monitored to identify complications.', 'detailedDescription': 'Providers will be surveyed twice at 4 and 8 months using open ended methods.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient receiving CAPP during study period.\n\nExclusion Criteria:\n\n* None (CAPP is only clinically indicated for obstetric hemorrhage post delivery.'}, 'identificationModule': {'nctId': 'NCT01497756', 'briefTitle': 'Feasibility Trial of the Circumferential Abdominal Pelvic Pressure Device (CAPP)', 'organization': {'class': 'OTHER', 'fullName': 'University of New Mexico'}, 'officialTitle': 'Feasibility Trial of the Circumferential Abdominal Pelvic Pressure Device (CAPP)', 'orgStudyIdInfo': {'id': '10-229'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CAPP application', 'description': 'Patients in whom device is used', 'interventionNames': ['Device: CAPP use']}], 'interventions': [{'name': 'CAPP use', 'type': 'DEVICE', 'description': 'Any abdominal pelvic pressure', 'armGroupLabels': ['CAPP application']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81435', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}], 'overallOfficials': [{'name': 'Mark Hauswald, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of New Mexico'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of New Mexico', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mark Hauswald', 'investigatorAffiliation': 'University of New Mexico'}}}}