Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-03-04 @ 10:42 PM
Study NCT ID:
NCT03251794
Status:
COMPLETED
Last Update Posted:
2018-06-27
First Post:
2017-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasonographic Evaluation of Fetal Adrenal Gland in Cases of Threatened Preterm Labor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-26', 'studyFirstSubmitDate': '2017-08-13', 'studyFirstSubmitQcDate': '2017-08-13', 'lastUpdatePostDateStruct': {'date': '2018-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the volume of adrenal gland', 'timeFrame': '5 minutes', 'description': 'measurement by three dimensional ultrasound'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Preterm Labor']}, 'descriptionModule': {'briefSummary': "Preterm birth continues to be a major public health problem with lasting family and societal repercussions. Despite tremendous research effort, prevention strategies have failed, and the prevalence of preterm birth in the United States reached 12.3% in 2003.\n\nPrematurity causes 70% of fetal/neonatal deaths. 11.4% of births are at \\< 37 weeks' gestation. The rate of prematurity increases dramatically with the number of fetuses - singletons 10%; twins 54.9%; and triplets 93.6%"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'women with threatened preterm labor', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. singleton fetus less than 37 weeks of gestation\n2. women diagnosed to having Threatened preterm labor.\n\n 1. presence of uterine contraction (at least 4 in 20 min or 8 in 60 min )\n 2. cervical effacement \\<80 %\n 3. cervical dilatation \\<1 cm\n\nExclusion Criteria:\n\n1. suspected fetal growth restriction,\n2. maternal medical complications,\n3. presence of fetal heart rate abnormalities at enrollment.\n4. Preterm Premature rupture of membranes\n5. Placenta previa\n6. Lower urinary tract infection or genital infection\n7. Fetal congenital anomaly'}, 'identificationModule': {'nctId': 'NCT03251794', 'briefTitle': 'Ultrasonographic Evaluation of Fetal Adrenal Gland in Cases of Threatened Preterm Labor', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Ultrasonographic Evaluation of Fetal Adrenal Gland in Cases of Threatened Preterm Labor', 'orgStudyIdInfo': {'id': 'FAGE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'threatened preterm labor', 'description': 'women presented to the reception unit from 28-37 weeks by regular contractions and opened cervix', 'interventionNames': ['Diagnostic Test: three dimensional ultrasound', 'Diagnostic Test: color Doppler']}], 'interventions': [{'name': 'three dimensional ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'evaluation of the suprarenal glands', 'armGroupLabels': ['threatened preterm labor']}, {'name': 'color Doppler', 'type': 'DIAGNOSTIC_TEST', 'description': 'Doppler evaluation of the suprarenal artery', 'armGroupLabels': ['threatened preterm labor']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut Faculty of Medicine', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Ahmed Mohamed Abbas', 'investigatorAffiliation': 'Assiut University'}}}}