Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2025-12-25 @ 4:14 PM
Study NCT ID:
NCT04438668
Status:
UNKNOWN
Last Update Posted:
2022-06-10
First Post:
2020-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Safety and Performance of Centaflow
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005317', 'term': 'Fetal Growth Retardation'}], 'ancestors': [{'id': 'D005315', 'term': 'Fetal Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006130', 'term': 'Growth Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised Controlled Trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1704}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-09', 'studyFirstSubmitDate': '2020-06-08', 'studyFirstSubmitQcDate': '2020-06-17', 'lastUpdatePostDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fetal Growth Restriction (FGR)', 'timeFrame': 'At birth', 'description': 'Outcome is the classification of each neonate as FGR or as non-FGR at birth. FGR is defined as birth weight below the 3rd percentile or birth weight below the 10th percentile and an antenatally detected abnormal umbilical artery blood flow.'}, {'measure': 'Safety: occurrence of device-related adverse events', 'timeFrame': 'At gestational week 27-29', 'description': 'Outcome is the occurrence of device-related adverse events and their classification as serious or not.'}, {'measure': 'Safety: occurrence of device-related adverse events', 'timeFrame': 'At gestational week 34-36', 'description': 'Outcome is the occurrence of device-related adverse events and their classification as serious or not.'}, {'measure': 'Safety: occurrence of device-related adverse events', 'timeFrame': 'At gestational week 37-39', 'description': 'Outcome is the occurrence of device-related adverse events and their classification as serious or not.'}], 'secondaryOutcomes': [{'measure': 'Mode of delivery', 'timeFrame': 'At birth', 'description': 'Outcome is the mode of delivery being either A) uncomplicated vaginal, B) complicated vaginal, C) planned cesarean section or D) emergency cesarean section.'}, {'measure': 'Neonatal Intensive Care Unit', 'timeFrame': 'At 12 days postpartum', 'description': 'Outcome is the occurrence of admission to the Neonatal Intensive Care Unit'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fetal Growth Restriction']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the safety and performance of an acoustic approach based on skin-contact microphones as a routine assessment of placental vascular function as predictor of fetal growth restriction.', 'detailedDescription': 'Evaluation of the safety and performance of Centaflow as routine antenatal assessment of placental vascular function as predictor of fetal growth restriction is performed by randomizing singleton pregnant women with ultrasound-based gestations for either standard care (SC) or SC and Centaflow (CF).\n\nThe subjects will be randomized in ratio 1:1 in both groups and examined in pregnancy weeks 27-29, 34-36 and 37-39.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Female subjects over the age of 18 years.\n* Subejct is pregnant, carries only one fetus and has been pregnancy dated by ultrasound scan (Hadlock reference).\n\nExclusion Criteria\n\n* Fetal abnormality known to affect growth, diagnosed in-utero or through 12 days postnatally.'}, 'identificationModule': {'nctId': 'NCT04438668', 'briefTitle': 'Evaluation of the Safety and Performance of Centaflow', 'organization': {'class': 'INDUSTRY', 'fullName': 'Centaflow'}, 'officialTitle': 'Evaluation of the Safety and Performance of Centaflow as a Routine Assessment of Placental Vascular Function and Foetal Cardiovascular Health', 'orgStudyIdInfo': {'id': '2019-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Care', 'description': "Standard care (SC) for screening for FGR is a healthcare provider auscultating the foetal heart rate with a standard stethoscope, palpation of foetal size by hand, and measuring the size of the woman's uterus with a tape measure, and comparing the measurement to the expected measurement for the gestational age of the foetus.", 'interventionNames': ['Diagnostic Test: Standard Care']}, {'type': 'EXPERIMENTAL', 'label': 'Standard Care and Centaflow', 'description': 'Centaflow uses sound-derived maternal intra-arterial turbulence as a marker of foetal growth restriction (FGR) and provides information on the foetal heart rate. Indication for use is as a screening device for FGR in women beyond 27 weeks of pregnancy with a singleton pregnancy.', 'interventionNames': ['Device: Centaflow and Standard Care']}], 'interventions': [{'name': 'Centaflow and Standard Care', 'type': 'DEVICE', 'otherNames': ['Standard Care is Symphysis-fundal measure and fetal weight estimation'], 'description': 'The intervention is screening methods', 'armGroupLabels': ['Standard Care and Centaflow']}, {'name': 'Standard Care', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Symphysis-fundal measure and fetal weight estimation'], 'description': 'The intervention is screening methods', 'armGroupLabels': ['Standard Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Olav Petersen, Professor', 'role': 'CONTACT', 'email': 'olav.bennike.bjoern.petersen@regionh.dk', 'phone': '+45 35 45 09 08'}], 'facility': 'Juliane Marie Centeret, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '8800', 'city': 'Viborg', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Richard Farlie, MD', 'role': 'CONTACT', 'email': 'richard.farlie@midt.rm.dk', 'phone': '+45 78445863'}], 'facility': 'Obstetrical Department, Regional Hospital Viborg', 'geoPoint': {'lat': 56.45319, 'lon': 9.40201}}], 'centralContacts': [{'name': 'Richard Farlie, MD, MI, MHM', 'role': 'CONTACT', 'email': 'richard.farlie@midt.rm.dk', 'phone': '+45 78 44 58 63'}, {'name': 'Olav Bjoern Petersen, Professor, MD', 'role': 'CONTACT', 'email': 'olav.bennike.bjoern.petersen@regionh.dk', 'phone': '+45 35 45 09 08'}], 'overallOfficials': [{'name': 'Richard Farlie, MD, MI, MHM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Viborg Regional Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Sharing raw data is inconsistent with the ethics application form and the participant informed consent materials.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centaflow', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, {'name': 'Viborg Regional Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}