Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT04450251
Status:
COMPLETED
Last Update Posted:
2025-09-22
First Post:
2020-06-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Testing a Wearable Monitor for Fetal Heart Rate Estimation, Fetal Movement and Uterine Activity Detection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 173}, 'targetDuration': '16 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2020-06-24', 'studyFirstSubmitQcDate': '2020-06-24', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The objective of this study is to collect observational fetal ECG readings with a novel wearable device', 'timeFrame': 'Up to 16 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pregnancy Tracker', 'Owlet Band', 'Owlet', 'Wearable Tech'], 'conditions': ['Pregnancy']}, 'descriptionModule': {'briefSummary': 'Owlet Baby Care, Inc. has developed a wearable fabric band pregnancy monitor, to be worn around the maternal abdomen incorporating electrocardiogram sensors. The purpose of this proposed test is to collect overnight "at-home" fetal ECG recordings on women during the second half of pregnancy using the pregnancy monitor.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Approximately 500 pregnant women 24 weeks gestation and up in the second or third trimester of pregnancy will be screened into the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant woman, 18 years of age and up.\n* Singleton or twin pregnancy.\n\nExclusion Criteria:\n\n* Self-reported substance abuse problems.\n* Anyone unable or unwilling to give informed consent.'}, 'identificationModule': {'nctId': 'NCT04450251', 'briefTitle': 'Testing a Wearable Monitor for Fetal Heart Rate Estimation, Fetal Movement and Uterine Activity Detection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Owlet Baby Care, Inc.'}, 'officialTitle': 'Testing a Wearable Monitor for Fetal Heart Rate Estimation, Fetal', 'orgStudyIdInfo': {'id': 'OWLET-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnant women, at least 24 weeks gestation', 'interventionNames': ['Other: Data Collection']}], 'interventions': [{'name': 'Data Collection', 'type': 'OTHER', 'description': 'Collect observational fetal electrocardiogram (ECG) readings with a novel wearable device.', 'armGroupLabels': ['Pregnant women, at least 24 weeks gestation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84043', 'city': 'Lehi', 'state': 'Utah', 'country': 'United States', 'facility': 'Owlet Baby Care, Inc.', 'geoPoint': {'lat': 40.39162, 'lon': -111.85077}}], 'overallOfficials': [{'name': 'Kenneth Ward, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Owlet Baby Care, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Owlet Baby Care, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}