Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-26 @ 4:35 AM
Study NCT ID:
NCT06898892
Status:
RECRUITING
Last Update Posted:
2025-03-27
First Post:
2025-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Sonographic and MRI Weight Estimation in Fetuses with Suspected Macrosomia
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': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-02-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2025-02-14', 'studyFirstSubmitQcDate': '2025-03-25', 'lastUpdatePostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MRI fetal weight estimation accuracy', 'timeFrame': 'from enollment to Performing the MRI at 1 week', 'description': 'gram'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fetal weight estimation, accuracy'], 'conditions': ['Accuracy of Sonographic Vs MRI Fetal Weight Estimation']}, 'referencesModule': {'references': [{'pmid': '1951539', 'type': 'BACKGROUND', 'citation': 'Langer O, Berkus MD, Huff RW, Samueloff A. Shoulder dystocia: should the fetus weighing greater than or equal to 4000 grams be delivered by cesarean section? Am J Obstet Gynecol. 1991 Oct;165(4 Pt 1):831-7. doi: 10.1016/0002-9378(91)90424-p.'}, {'pmid': '34358479', 'type': 'BACKGROUND', 'citation': 'Kadji C, Cannie MM, Kang X, Carlin A, Benjou Etchoua S, Resta S, Dutemeyer V, Abi-Khalil F, Mazzone E, Bevilacqua E, Jani JC. Fetal magnetic resonance imaging at 36 weeks predicts neonatal macrosomia: the PREMACRO study. Am J Obstet Gynecol. 2022 Feb;226(2):238.e1-238.e12. doi: 10.1016/j.ajog.2021.08.001. Epub 2021 Aug 4.'}, {'pmid': '26224221', 'type': 'BACKGROUND', 'citation': 'Malin GL, Bugg GJ, Takwoingi Y, Thornton JG, Jones NW. Antenatal magnetic resonance imaging versus ultrasound for predicting neonatal macrosomia: a systematic review and meta-analysis. BJOG. 2016 Jan;123(1):77-88. doi: 10.1111/1471-0528.13517. Epub 2015 Jul 29.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare the accuracy of sonographic vs. magnetic resonance fetal weight estimation in suspected fetal macrosomia in term pregnancy.\n\nPregnant patient at term with suspected macrosomia will participate and undergo both sonographic and magnetic resonance fetal weight estimations and the actual birthweight will be recorded and compared with the fetal weight estimations', 'detailedDescription': 'The goal of this clinical trial is to compare the accuracy of sonographic vs. magnetic resonance fetal weight estimation in suspected fetal macrosomia in term pregnancy.\n\nPregnant patient at term with suspected macrosomia will participate and undergo both sonographic and magnetic resonance fetal weight estimations and the actual birthweight will be recorded and compared with the fetal weight estimations inclusion criteria: singleton pregnancies at term, suspected fetal macrosomia (\\>4000 gr in non GDM and \\>3800 gr. in GDM cases exclusion criteria-fetal anomaly, PPROM, multiple gestation The radiologist and the sonographer will be blinded to the fetal weight estimation and to the other estimation done'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'pregnant women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nsingleton pregnancy at term, suspected fetal macrosomia,\n\nExclusion Criteria:\n\n* fetal anomaly multiple pregnancy PROM'}, 'identificationModule': {'nctId': 'NCT06898892', 'briefTitle': 'Comparison of Sonographic and MRI Weight Estimation in Fetuses with Suspected Macrosomia', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Western Galilee Hospital-Nahariya'}, 'officialTitle': 'Comparison of the Accuracy of Fetal Weight Estimation Between Sonographic Vs. Magnetic Resonance Assessment', 'orgStudyIdInfo': {'id': '0249-24-NHR'}, 'secondaryIdInfos': [{'id': 'Galilee medical center', 'type': 'OTHER', 'domain': 'Bar Ilan University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'suspected macrosomia', 'description': 'suspected macrosomia at term who will undergo sonographic and MRI fetal weight estimation', 'interventionNames': ['Diagnostic Test: Fetal MRI']}], 'interventions': [{'name': 'Fetal MRI', 'type': 'DIAGNOSTIC_TEST', 'description': 'all participant will undergo MRI fetal weight estimation', 'armGroupLabels': ['suspected macrosomia']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nahariya', 'status': 'RECRUITING', 'country': 'Israel', 'facility': 'Galilee medical center', 'geoPoint': {'lat': 33.00892, 'lon': 35.09814}}], 'centralContacts': [{'name': 'Maya Frank Wolf, Prof.', 'role': 'CONTACT', 'email': 'mayaw@gmc.gov.il', 'phone': '972-50-7887800'}], 'overallOfficials': [{'name': 'Amal shahin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Galilee Medical Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Western Galilee Hospital-Nahariya', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Maternal Fetal Medicine Unit', 'investigatorFullName': 'Dr. Maya Wolf', 'investigatorAffiliation': 'Western Galilee Hospital-Nahariya'}}}}