Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2026-01-19 @ 12:50 PM
Study NCT ID:
NCT06540092
Status:
COMPLETED
Last Update Posted:
2024-08-06
First Post:
2024-08-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Pregnancy Ultrasound Measurements and Prediction of First Trimester Pregnancy Loss.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-01', 'studyFirstSubmitDate': '2024-08-01', 'studyFirstSubmitQcDate': '2024-08-01', 'lastUpdatePostDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The relation between early pregnancy ultrasound measurements (GSD, YSD, CRL, HR), viability, and continuation of pregnancy till 13 weeks of gestation.', 'timeFrame': '6-7 weeks', 'description': '2 measures of the fetus were obtained and compared to get first trimester pregnancy outcome'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ultrasound measurments'], 'conditions': ['First Trimester Abortion']}, 'descriptionModule': {'briefSummary': 'Ultrasound measurements of fetus during first trimester may be an indicator of first trimester pregnancy loss. Investigators took 4 measurements of the fetus on 2 intervals during first trimester to confirm this hypothesis.', 'detailedDescription': 'Ultrasound examination of gestational sac (GS) diameter, yolk sac (YS) diameter, crown rump length (CRL) diameter, embryonal heart rate (HR) using Samsung Medison SonoAce R3 through transvaginal probes (6.5 MHz) was conducted on 126 pregnant women. At least 2 scans were done for each participant one between 6-8 weeks and another one by the end of first trimester. Results then were compared to get the cut off values that can predict pregnancy loss.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '126 pregnant women between 6- 13 weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Healthy pregnant female patient in the reproductive age group; 18 - 40 years old.\n\n * Gestational age: 6 - 13 weeks of gestations.\n * Singlton or multifetal pregnancy.\n * Any mode of conception included spontaneous, after superovulation with clomiphene citrate or letrozole with, or without, intrauterine insemination (IUI), and in vitro fertilization (IVF) after superovulation with gonadotropins.\n\nExclusion Criteria:\n\n* • Patient with unsure date for the last menstrual period.\n\n * Pregnant women above 13 weeks gestation.\n * Patient with symptoms of threatened abortion or ectopic pregnancy at the initial antenatal visit.\n * Patient unable to come for follow up.\n * Any medical disorders as DM, HTN, …'}, 'identificationModule': {'nctId': 'NCT06540092', 'briefTitle': 'Early Pregnancy Ultrasound Measurements and Prediction of First Trimester Pregnancy Loss.', 'organization': {'class': 'OTHER', 'fullName': 'Kasr El Aini Hospital'}, 'officialTitle': 'Early Pregnancy Ultrasound Measurements and Prediction of First Trimester Pregnancy Loss.', 'orgStudyIdInfo': {'id': 'MS-521-2023'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'ultrasound measurements during first trimester'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11562', 'city': 'Cairo', 'state': 'Old Cairo', 'country': 'Egypt', 'facility': 'kasr Al Aini, Faculty of Medicine, Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kasr El Aini Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Obstetrics and Gynecology, Cairo University', 'investigatorFullName': 'Hend Mahmoud Abdelghany', 'investigatorAffiliation': 'Kasr El Aini Hospital'}}}}