Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2026-02-28 @ 2:50 AM
Study NCT ID:
NCT00502918
Status:
TERMINATED
Last Update Posted:
2009-12-29
First Post:
2007-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Feasibility of Computerized Labor Monitor (CLM) -Heart Application (HA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'The study was terimnated - low rate of cases', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-07', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-12-27', 'studyFirstSubmitDate': '2007-07-17', 'studyFirstSubmitQcDate': '2007-07-17', 'lastUpdatePostDateStruct': {'date': '2009-12-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Monitoring fetal heart movement', 'timeFrame': 'During labour'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obstetrics', 'Labor']}, 'descriptionModule': {'briefSummary': 'The study is a feasibility study to check the possibility of tracking the heart rate of the fetus and to translate the outcome to the progress of the labor', 'detailedDescription': "Every year, millions of babies are born worldwide. Yet, despite great advances in medical technology, the method used to obtain the most critical parameter in labor management - cervix dilatation, remains a vaginal (manual) examination. This vaginal examination, intended to estimate the dilatation of the cervix and the progress of the baby's head, is inaccurate, non-continuous and involves the risk of infection to both fetus and mother. It is also uncomfortable to the mother. The consequences of infections or delayed treatment may range from simple complications to irreversible damage. Early detection of abnormal patterns of labor progress could prevent complications and shorten the labor process and hospitalization, thereby saving both aggravation and cost.\n\nTo truly manage the labor process, a labor management system is required. Such a system is expected to provide the obstetrical staff with the flow of accurate, continuous, real-time information, such as cervix dilatation."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Laboring women reffered to the maternity center in active labor (3cm - 7 cm) dilataion and contraction', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Laboring women refered to the maternity center in active labor (3cm dilatation and contraction)\n2. Gestational age 37-42 weeks. (GA)\n3. Single Fetus.\n4. Subjects who understand, agreed and signed the informed consent form.\n\nExclusion Criteria:\n\n1. Women with abnormal placentation (Placenta previa) -\n2. Abnormal fetal presentation (Breech presentation).\n3. Maternal History of HIV and/or blood transmitted Hepatitis and /or active genital Herpes.\n4. Need for immediate delivery (cord prolapsed or suspected placental abruption)'}, 'identificationModule': {'nctId': 'NCT00502918', 'briefTitle': 'Clinical Feasibility of Computerized Labor Monitor (CLM) -Heart Application (HA)', 'organization': {'class': 'OTHER', 'fullName': 'Barnev Ltd'}, 'officialTitle': 'Feasibility Study -Clinical Feasibility of Computerized Labor Monitor (CLM) -Heart Application', 'orgStudyIdInfo': {'id': 'TASMC-07-AM-279-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'interventionNames': ['Device: CLM - HA Continuous Monitoring System Heart Application']}], 'interventions': [{'name': 'CLM - HA Continuous Monitoring System Heart Application', 'type': 'DEVICE', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Tel Aviv Soraski medical center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'overallOfficials': [{'name': 'Ariel Many, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sackler School od Medicine , Tel Aviv University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barnev Ltd', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Clinical Trial Manager', 'oldOrganization': 'Barnev Ltd'}}}}