Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-29 @ 12:10 PM
Study NCT ID:
NCT04941534
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2021-06-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
This Clinical Study Evaluates the Performance and Safety of Biorithm Research Kit Versus CTG in Prenatal Monitoring of Pregnant Participants.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-07', 'studyFirstSubmitDate': '2021-06-22', 'studyFirstSubmitQcDate': '2021-06-22', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fetal Heart Rate (FHR)', 'timeFrame': '60 minutes', 'description': 'FHR agreement between Biorithm Research Kit and standard of care (CTG)'}, {'measure': 'Maternal Heart Rate (MHR)', 'timeFrame': '60 minutes', 'description': 'MHR agreement between Biorithm Research Kit and standard of care (CTG)'}]}, 'conditionsModule': {'keywords': ['antepartum monitoring'], 'conditions': ['Pregnancy']}, 'referencesModule': {'references': [{'pmid': '37055213', 'type': 'DERIVED', 'citation': 'Liu B, Marler E, Thilaganathan B, Bhide A. Ambulatory antenatal fetal electrocardiography in high-risk pregnancies (AMBER): protocol for a pilot prospective cohort study. BMJ Open. 2023 Apr 13;13(4):e062448. doi: 10.1136/bmjopen-2022-062448.'}, {'pmid': '36944583', 'type': 'DERIVED', 'citation': 'Liu B, Thilaganathan B, Bhide A. Effectiveness of ambulatory non-invasive fetal electrocardiography: impact of maternal and fetal characteristics. Acta Obstet Gynecol Scand. 2023 May;102(5):577-584. doi: 10.1111/aogs.14543. Epub 2023 Mar 21.'}]}, 'descriptionModule': {'briefSummary': 'This clinical study will evaluate the safety and comparative performance of Biorithm Research Kit vs CTG (gold standard) in prenatal monitoring of pregnant participants.', 'detailedDescription': "The Biorithm Research Kit system used in this study consists of femom fetal monitor (known as fetal monitor), a digital gateway and a cloud storage. It's intended for monitoring of maternal and fetal physiological parameters. It includes non-invasive fetal monitor or device, that monitors fetal heart rate (FHR), maternal heart rate (MHR), and uterine activity (UA) in the antepartum period."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants would be recruited at the Day Assessment Unit who require CTG monitoring and meet the inclusion criteria', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a singleton pregnancy\n* Should be at and above 28 weeks of pregnancy\n* Should have a valid indication for antenatal FHR monitoring as part of their pregnancy management, as per local hospital policy\n* Able to speak English or have access to an interpreter and provide Informed Consent\n\nExclusion Criteria:\n\n* Participants with an intellectual or mental impairment\n* Participants with a known allergy or hypersensitivity to ECG gel electrodes\n* Participants in pain, with contractions or in labour\n* Known fetal cardiac or genetic abnormality\n* Participant with a pacemaker'}, 'identificationModule': {'nctId': 'NCT04941534', 'briefTitle': 'This Clinical Study Evaluates the Performance and Safety of Biorithm Research Kit Versus CTG in Prenatal Monitoring of Pregnant Participants.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biorithm Pte Ltd'}, 'officialTitle': 'AMBulatory Fetal ECG Monitoring in High Risk Pregnancies', 'orgStudyIdInfo': {'id': 'AMBER'}}, 'contactsLocationsModule': {'locations': [{'zip': 'SW17ORE', 'city': 'London', 'country': 'United Kingdom', 'facility': "St George's University Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Baskaran Thilaganathan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St-George's University Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biorithm Pte Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}