Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-31 @ 11:37 PM
Study NCT ID:
NCT03741569
Status:
COMPLETED
Last Update Posted:
2022-12-16
First Post:
2018-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multisensor Technology for Beat to Beat Fetal Heart Rate Measurement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-07-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-15', 'studyFirstSubmitDate': '2018-11-12', 'studyFirstSubmitQcDate': '2018-11-14', 'lastUpdatePostDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The fetal heart rate signal', 'timeFrame': 'at 15 minutes', 'description': 'The fetal heart rate signal extraction algorithm will be based on the various signal processing tools developed by the INSERM CIC-IT 1403 laboratory'}], 'secondaryOutcomes': [{'measure': 'The uterine contraction signal', 'timeFrame': 'at 15 minutes', 'description': 'The uterine contraction signal extraction algorithm will be based on the different signal processing tools developed by the INSERM CIC-IT 1403 laboratory.'}, {'measure': 'Measuring the root mean square deviation between the heart rate signals from the device and the Doppler', 'timeFrame': 'at 15 minutes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fetal heart rate', 'Multiple sensors'], 'conditions': ['Obstetric Labor']}, 'descriptionModule': {'briefSummary': "The CIC-IT 1403 laboratory of the University Hospital of Lille has developed a technological solution for acquiring and synchronizing abdominal ECG, acoustic and Doppler signals.\n\nThe purpose of this clinical trial is to build a database of signals issued from this device to develop signal processing algorithms to allow optimization of the fetal heart rate calculation.\n\nThis study will be carried out in the maternity ward of the Jeanne de Flandre Hospital in the maternal-fetal pathology department Doppler, ECG and acoustic sensors will be placed on the mother's abdomen to capture the heart rate of the fetus and mother as well as uterine contractions.\n\nFor each of the participants, we will make two 15-minute recordings: one with conventional ECG electrodes and one with ECG textile electrodes.\n\nThis procedure will not affect the usual care of the patient"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Pregnant woman', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant woman\n* Age\\>18 years\n\nExclusion Criteria:\n\n* Multiple pregnancy\n* Medical termination of pregnancy'}, 'identificationModule': {'nctId': 'NCT03741569', 'acronym': 'RCF-ABDO', 'briefTitle': 'Multisensor Technology for Beat to Beat Fetal Heart Rate Measurement', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Development of a Real-time Signal Processing Algorithm, for Beat-beat Measurement of Fetal Heart Rate and Uterine Contractions by Coupling Non-invasive ABDOminal Sensors', 'orgStudyIdInfo': {'id': '2017_63'}, 'secondaryIdInfos': [{'id': '2018-A01194-51', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'parturients (gestational age ≥37 weeks).', 'interventionNames': ['Device: Transabdominal Fetal Heart Rate']}], 'interventions': [{'name': 'Transabdominal Fetal Heart Rate', 'type': 'DEVICE', 'otherNames': ['Fetal heart rate recording'], 'description': "Doppler, ECG and acoustic sensors will be placed on the mother's abdomen to capture the heart rate of the fetus and mother as well as uterine contractions.\n\nFor each of the participants, we will make two 15-minute recordings: one with conventional ECG electrodes and one with ECG textile electrodes", 'armGroupLabels': ['parturients (gestational age ≥37 weeks).']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Roger Salengro, CHU', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Charles Garrabedian, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}