Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-01-09 @ 7:40 PM
Study NCT ID:
NCT06497205
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-07-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AMBulatory Fetal ECG Monitoring in Low and High-Risk Pregnancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-04', 'studyFirstSubmitDate': '2024-07-04', 'studyFirstSubmitQcDate': '2024-07-04', 'lastUpdatePostDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FHR', 'timeFrame': '60 minutes', 'description': 'FHR agreement between Femom system and standard of care (CTG)'}, {'measure': 'MHR', 'timeFrame': '60 minutes', 'description': 'MHR agreement between Femom system and standard of care (CTG)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pregnancy Related']}, 'referencesModule': {'references': [{'pmid': '41022451', 'type': 'DERIVED', 'citation': 'Pegorie C, Liu B, Thilaganathan B, Bhide A. Ambulatory foetal ECG monitoring in low and high-risk pregnancies (AMBER2): a prospective cohort study protocol. BMJ Open. 2025 Sep 28;15(9):e096123. doi: 10.1136/bmjopen-2024-096123.'}]}, 'descriptionModule': {'briefSummary': "This study is a planned research project to test and demonstrate the feasibility of using the Femom device for monitoring fetal heart rate remotely.\n\nThe main goal is to learn if the remote recordings using Femom provide reliable information about the baby's heart rate. We will also establish reference standards of heart rate variability in uncomplicated pregnancies at different stages of pregnancy. Additionally, we will compare the heart rate variability in FGR and diabetic pregnancies to normal pregnancies.", 'detailedDescription': 'The Femom device is a non-invasive fetal ECG (NIFECG) device which has been developed for self application and remote monitoring. Women from three different cohort groups (controls, FGR and insulin dependent diabetes) will be approached and asked to monitor their baby at home once a day. Women in the control group will be asked to do this once a day for one week, the FGR pregnancies until delivery and the insulin dependent diabetics just from 36 weeks until delivery.\n\nThe data will be collected and analysed retrospectively to assess compliance of the participants with the study protocol, signal quality and establish reference standards in relation to gestation within the control group. Heart rate variability measures in the FGR and diabetes arm will be compared to the reference standards in the control group. Outcomes of the pregnancy.\n\nFeedback regarding the usability of the device will also be collected using a feedback questionnaire to assess the feasibility of home antenatal monitoring.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Women booked for antenatal care at St. George's hospital or women under the care of the Fetal medicine unit at St. George's hospital will be invited to participate in this study.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singleton live pregnancy\n* \\> 26 weeks gestational age\n* Able to speak English or available NHS interpreter\n\nExclusion Criteria:\n\n* Women below 18 years of age\n* Women with an intellectual or mental impairment\n* Women with a known allergy or hypersensitivity to ECG gel electrodes\n* Known fetal cardiac or genetic abnormality.\n* Patient with existing dependent or unequal relationships with any member of the research team, the researchers(s) and/or the person undertaking the recruitment/consent process.\n* Inability to access interpreter.'}, 'identificationModule': {'nctId': 'NCT06497205', 'briefTitle': 'AMBulatory Fetal ECG Monitoring in Low and High-Risk Pregnancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biorithm Pte Ltd'}, 'officialTitle': 'AMBulatory Fetal ECG Monitoring in Low and High-Risk Pregnancies', 'orgStudyIdInfo': {'id': 'AMBER2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control Group', 'description': 'low risk ASPRE'}, {'label': 'FGR Group', 'description': 'FGR according to definition of ISUOG'}, {'label': 'Diabetic Group', 'description': 'insulin dependent diabetes'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW17 0QT', 'city': 'London', 'state': 'Tooting', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Claire Pegorie, MBBS', 'role': 'CONTACT', 'email': 'Claire.Pegorie00@stgeorges.nhs.uk', 'phone': '+447557803882'}], 'facility': 'St Georges University Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Vilasini Nair', 'role': 'CONTACT', 'email': 'vilanair@bio-rithm.com', 'phone': '+659628109'}], 'overallOfficials': [{'name': 'Amarnath Bhide, MBBS, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St Georges University Hospitals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biorithm Pte Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}