Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2025-12-25 @ 11:07 PM
Study NCT ID:
NCT05066867
Status:
UNKNOWN
Last Update Posted:
2021-10-04
First Post:
2021-09-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
LMWH Compliance in Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-23', 'studyFirstSubmitDate': '2021-09-23', 'studyFirstSubmitQcDate': '2021-09-23', 'lastUpdatePostDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LMWH compliance levels in pregnancy', 'timeFrame': '18 months', 'description': 'Compliance is described as a patient taking at least 80% of LMWH injections'}], 'secondaryOutcomes': [{'measure': 'Sociodemographic factors', 'timeFrame': '18 months', 'description': 'To determine sociodemographic factors that influence compliance'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pregnancy thromboprophylaxis', 'LMWH compliance'], 'conditions': ['Venous Thromboembolism', 'Antenatal Deep Vein Thrombosis']}, 'descriptionModule': {'briefSummary': "This is a prospective chart study that will aim to assess objective data on compliance levels to low molecular weight heparin (LMWH) injections among pregnant and postnatal women undergoing VTE thromboprophylaxis treatment at Cork University Maternity Hospital. This is a study that will help shine light on accurate data for compliance and possible factors affecting it, which will be useful for more individualised treatment plans for future patients. Patients at higher risk of Venous thromboembolism undergoing VTE thromboprophylaxis will be invited to participate in the study. Once the patient reads the information leaflet and signs consent, data will then be collected from the patients medical record. The patient will be given a smart sharps bin with an individual, unique product code. This device will be provided by HealthBeacon, a Dublin based start-up company. The device will be personalised with the treatment schedule pre-loaded onto it. When a used LMWH injection is disposed into the smart sharps bin, an infrared sensor is activated. The system captures an image of the injection in the chamber before moving it to the normal 'sharps' container of the bin for disposal. The captured image is time-stamped and sent to HealthBeacon's electronic database. HealthBeacon will only have the data pertaining to the disposal of injections for each sharps bin (i.e. the timing of the disposal of each used injection in each pre-coded bin). We are blinded to the compliance information and will only will receive the raw Data once treatment is completed. Data will be analysed to determine compliance of LMWH injections. This study will enable us to have a better insight on accurate compliance rates for LMWH injections in pregnant women at higher risk for venous thromboembolism (VTE). Understanding compliance with LMWH injections and the factors which can affect it, will hopefully guide future information and education that we offer to patients who are prescribed LMWH injections and help decrease maternal mortality rates in future."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Antenatal and postnatal women at higher risk of VTE, commenced on LMWH \\& fitting the inclusion criteria', 'genderDescription': 'Antenatal and postnatal woman at higher risk of VTE commenced on LMWH thromboprophylaxis fitting the inclusion criteria', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* current VTE\n* previous history of VTE\n* class III obesity\n* history of placenta mediated complications\n* pre-eclampsia\n* Advanced Maternal Age\n* inherited thrombophilia\n* prolonged immobilization\n* varicose veins\n* other risk factors that predispose them to VTE\n\nExclusion Criteria:\n\n* life-long anti-coagulation\n* mechanical heart valves\n* other forms of injectable therapy for other illnesses\n* long-term severe physical disability affecting mobility (eg: paraplegia, paralysis'}, 'identificationModule': {'nctId': 'NCT05066867', 'briefTitle': 'LMWH Compliance in Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Cork University Maternity Hospital'}, 'officialTitle': 'Compliance With Long-term Low-molecular-weight Heparin Prophylaxis/Treatment in the Anatenatal and Postnatal Population', 'orgStudyIdInfo': {'id': 'CorkUMH'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Smart sharps bin - collects data on compliance', 'type': 'OTHER', 'description': 'collects compliance data'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cork', 'status': 'RECRUITING', 'country': 'Ireland', 'contacts': [{'name': 'Rebecca Cole', 'role': 'CONTACT', 'email': 'rebecca.cole@ucc.ie'}, {'name': 'Rebecca Cole', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Fergus McCarthy', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Karthika Annamalai', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ali Khashan', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cork University Maternity Hospital', 'geoPoint': {'lat': 51.89797, 'lon': -8.47061}}], 'centralContacts': [{'name': 'Rebecca M Cole, M.B.', 'role': 'CONTACT', 'email': 'rebecca.cole@ucc.ie', 'phone': '+353214920500'}, {'name': 'John RJ Higgins, M.D.', 'role': 'CONTACT', 'email': 'j.higgins@ucc.ie', 'phone': '+353214920749'}], 'overallOfficials': [{'name': 'John RJ Higgins, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CUMH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cork University Maternity Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'HealthBeacon ICMS', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor/Clinical Director', 'investigatorFullName': 'John R Higgins', 'investigatorAffiliation': 'Cork University Maternity Hospital'}}}}