Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-01-01 @ 12:46 AM
Study NCT ID:
NCT01005667
Status:
WITHDRAWN
Last Update Posted:
2011-06-23
First Post:
2009-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Determine if Monitoring of Labor Shortens the Time to Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'whyStopped': 'Lack of funding for the company has resulted in termination of the study.', 'overallStatus': 'WITHDRAWN', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'lastUpdateSubmitDate': '2011-06-22', 'studyFirstSubmitDate': '2009-10-30', 'studyFirstSubmitQcDate': '2009-10-30', 'lastUpdatePostDateStruct': {'date': '2011-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shortened time to vaginal delivery', 'timeFrame': 'Length of labor until delivery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nulliparous women in spontaneous labor'], 'conditions': ['Pregnancy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the hypothesis that using the BirthTrack for management of labor shortens the time to delivery and thus improves both maternal and perinatal outcomes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The patient must be ≥ 18 years old\n* Nulliparous\n* Singleton fetus in vertex presentation\n* Gestational age 36-0/7 or more\n* Reassuring fetal heart tracing\n\nExclusion Criteria:\n\n* Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study\n* Low lying placenta (edge 3cm or less from cervix)\n* Known or suspected fetal or maternal infection\n* Maternal thrombocytopenia (platelet count \\<100,000)\n* Maternal bleeding disorder\n* Women with previous uterine surgery\n* Known major fetal malformation\n* Suspected fetal growth restriction (EFW\\<10th percentile)\n* Subjects with significant psychiatric history\n* Major maternal morbidity (e.g. major cardiac disease)\n* Subjects with indication for immediate delivery\n* Limit on cervical dilation (e.g., up to 7 cm.)\n* Prolonged rupture of membranes (i.e., \\> 24 hours)"}, 'identificationModule': {'nctId': 'NCT01005667', 'acronym': 'BirthTrack', 'briefTitle': 'Study to Determine if Monitoring of Labor Shortens the Time to Delivery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Barnev, Inc.'}, 'officialTitle': 'Management of Labor Using the BirthTrack Computerized Labor Monitoring System', 'orgStudyIdInfo': {'id': 'BBT1600'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BirthTrack Monitor', 'interventionNames': ['Device: BirthTrack']}, {'type': 'NO_INTERVENTION', 'label': 'Control - no BirthTrack Monitor'}], 'interventions': [{'name': 'BirthTrack', 'type': 'DEVICE', 'otherNames': ['Computerized Labor Monitoring System'], 'description': 'Measurement of cervical dilation and head station', 'armGroupLabels': ['BirthTrack Monitor']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 1X5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Barak M Rosenn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Luke's-Roosevelt Hospital Center"}, {'name': 'Dan Farine, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MOUNT SINAI HOSPITAL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barnev, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'John Quigley', 'oldOrganization': 'Barnev, Inc.'}}}}