Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-02-25 @ 7:27 PM
Study NCT ID:
NCT02396667
Status:
UNKNOWN
Last Update Posted:
2020-07-09
First Post:
2015-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy of 5D LB Ultrasound in Prediction of Birth Weight in Macrosomic Babies : A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-07', 'studyFirstSubmitDate': '2015-03-19', 'studyFirstSubmitQcDate': '2015-03-23', 'lastUpdatePostDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of 5D ultrasound in predicting actual birth weight in comparison to 2D ultrasound. (estimated by hadlock formula - Accuracy of estimated fetal weight by ultrasound will be compared to actual birth weight)', 'timeFrame': '72hours'}]}, 'conditionsModule': {'conditions': ['Macrosomia']}, 'descriptionModule': {'briefSummary': '5D and 2D ultrasounds will be done for pregnant women with macrosomic fetuses to determine estimated fetal weight using hadlock formula. The accuracy of fetal weight obtained by ultrasound will be compared to actual birth weight.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women between 37 and 42 weeks with macrosomic fetuses.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 37 to 42 weeks gestation\n* macrosomic fetuses\n* maternal diabetes\n\nExclusion Criteria:\n\n* intrauterine fetal death\n* multiple pregnancy\n* congenital anomaly\n* nonvisualized fetal parts'}, 'identificationModule': {'nctId': 'NCT02396667', 'briefTitle': 'Accuracy of 5D LB Ultrasound in Prediction of Birth Weight in Macrosomic Babies : A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Accuracy of 5D LB Ultrasound in Prediction of Birth Weight in Macrosomic Babies: A Pilot Study', 'orgStudyIdInfo': {'id': 'm2493'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'pregnant women with macrosomia', 'description': 'Pregnant wo.en between 37 and 42 weeks with fetal macrosomia as suspected by clinical estimation and 2D ultrasound.', 'interventionNames': ['Other: 5D ultrasound']}], 'interventions': [{'name': '5D ultrasound', 'type': 'OTHER', 'description': 'Measure the femur length by 5DLB to calculate fetal weight', 'armGroupLabels': ['pregnant women with macrosomia']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams Maternity Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'dr mohamed laban', 'investigatorAffiliation': 'Ain Shams University'}}}}