Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-02-27 @ 12:49 AM
Study NCT ID:
NCT06343051
Status:
RECRUITING
Last Update Posted:
2025-02-10
First Post:
2024-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
USCOM in Newly Diagnosed FGR Cases
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-06', 'studyFirstSubmitDate': '2024-03-27', 'studyFirstSubmitQcDate': '2024-03-27', 'lastUpdatePostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systemic vascular resistance obtained from USCOM', 'timeFrame': 'every 2-4 weeks at time of prenatal ultrasound, until the end of pregnancy', 'description': 'Cardiac output related to systemic vascular resistance (SVR) obtained from the USCOM device. SVR is an indicator of general resistance experienced within the circulatory system and is correlated with an array of cardiac related adverse health outcomes. The USCOM device uses noninvasive ultrasonographic technology to determine SVR at the time of prenatal ultrasound.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Fetal Growth Restriction', 'USCOM']}, 'descriptionModule': {'briefSummary': "The purpose of this research study is to study the use of an ultrasound measurement system (USCOM) for patients with newly diagnosed fetal growth restriction (FGR). This system uses a technology to measure how much blood is being pumped in and out of the heart, which is important for understanding the heart's function in relation to pregnancy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients with newly diagnosed fetal growth restriction at greater than 27 weeks 6 days' gestation will be eligible to enroll in this study.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant patients with a new diagnosis of fetal growth restriction (estimated fetal weight \\<10th percentile or abdominal circumference \\<10th percentile) in the third trimester (gestational age \\>27w6d)\n\nExclusion Criteria:\n\n* Multiple gestation\n* Fetal anomalies\n* Gestational diabetes or pregestational diabetes.'}, 'identificationModule': {'nctId': 'NCT06343051', 'acronym': 'USCOM FGR', 'briefTitle': 'USCOM in Newly Diagnosed FGR Cases', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Ultrasound Hemodynamic Assessment in Newly Diagnosed Fetal Growth Restriction: A Pilot Study', 'orgStudyIdInfo': {'id': 'STUDY-23-01681'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fetal Growth Restriction diagnosed > 27w6d gestation', 'description': "Patients with a new diagnosis of fetal growth restriction after 27 weeks 6 days' gestation.", 'interventionNames': ['Device: USCOM']}], 'interventions': [{'name': 'USCOM', 'type': 'DEVICE', 'description': 'Device that measures how much blood is being pumped in and out of the heart.', 'armGroupLabels': ['Fetal Growth Restriction diagnosed > 27w6d gestation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nicola F Tavella, MPH', 'role': 'CONTACT', 'email': 'nicola.tavella@mssm.edu', 'phone': '2122413888'}, {'name': 'Rachel J Meislin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Nicola F Tavella, MPH', 'role': 'CONTACT', 'email': 'nicola.tavella@mssm.edu', 'phone': '212-241-3888'}, {'name': 'Allison Perelman, MD', 'role': 'CONTACT', 'email': 'allison.perelman@mssm.edu'}], 'overallOfficials': [{'name': 'Nicola F Tavella, MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}, {'name': 'Rachel J Meislin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Immediately following publication. No end date.', 'ipdSharing': 'YES', 'description': 'All of the individual participant data collected during the trial, after deidentification.', 'accessCriteria': 'Researchers who provide a methodologically sound proposal. Any purpose. Proposals should be directed to Nicola.tavella@mssm.edu. To gain access, data requestors will need to sign a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Rachel Meislin', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}