Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2026-02-23 @ 8:57 PM
Study NCT ID:
NCT06761794
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-07
First Post:
2024-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Normogram of Umbilical Artery and Fetal Middle Cerebral Artery Doppler Indices in Upper Egyptian Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 520}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-06', 'studyFirstSubmitDate': '2024-12-22', 'studyFirstSubmitQcDate': '2025-01-06', 'lastUpdatePostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pulsatility index of umbilical artery.', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'Resistive index of umbilical artery', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'pulsatility index of fetal middle cerebral artery.', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'Resistive index of fetal middle cerebral artery', 'timeFrame': 'Through study completion, an average of 1 year'}], 'secondaryOutcomes': [{'measure': 'settle cerebroplacental ratio local reference range.', 'timeFrame': 'Through study completion, an average of 1 year'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Doppler in Normal Pregnancy']}, 'referencesModule': {'references': [{'pmid': '15746695', 'type': 'BACKGROUND', 'citation': 'Acharya G, Wilsgaard T, Berntsen GK, Maltau JM, Kiserud T. Reference ranges for serial measurements of umbilical artery Doppler indices in the second half of pregnancy. Am J Obstet Gynecol. 2005 Mar;192(3):937-44. doi: 10.1016/j.ajog.2004.09.019.'}, {'pmid': '15789353', 'type': 'BACKGROUND', 'citation': 'Mari G. Middle cerebral artery peak systolic velocity for the diagnosis of fetal anemia: the untold story. Ultrasound Obstet Gynecol. 2005 Apr;25(4):323-30. doi: 10.1002/uog.1882. No abstract available.'}, {'pmid': '17721916', 'type': 'BACKGROUND', 'citation': 'Ebbing C, Rasmussen S, Kiserud T. Middle cerebral artery blood flow velocities and pulsatility index and the cerebroplacental pulsatility ratio: longitudinal reference ranges and terms for serial measurements. Ultrasound Obstet Gynecol. 2007 Sep;30(3):287-96. doi: 10.1002/uog.4088.'}, {'pmid': '21353090', 'type': 'BACKGROUND', 'citation': 'Maulik D, Mundy D, Heitmann E, Maulik D. Umbilical artery Doppler in the assessment of fetal growth restriction. Clin Perinatol. 2011 Mar;38(1):65-82, vi. doi: 10.1016/j.clp.2010.12.004.'}, {'pmid': '19111026', 'type': 'BACKGROUND', 'citation': 'Tarzamni MK, Nezami N, Gatreh-Samani F, Vahedinia S, Tarzamni M. Doppler waveform indices of fetal middle cerebral artery in normal 20 to 40 weeks pregnancies. Arch Iran Med. 2009 Jan;12(1):29-34.'}, {'pmid': '11169324', 'type': 'BACKGROUND', 'citation': 'Dubiel M, Breborowicz GH, Marsal K, Gudmundsson S. Fetal adrenal and middle cerebral artery Doppler velocimetry in high-risk pregnancy. Ultrasound Obstet Gynecol. 2000 Oct;16(5):414-8. doi: 10.1046/j.1469-0705.2000.00278.x.'}]}, 'descriptionModule': {'briefSummary': 'settle umbilical and fetal middle cerebral arteries Doppler indices( pulsatility index and resistive index) in normal pregnancy to generate a local reference range and calculate cerebroplacental ratio.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women with gestational age 15-40 wk, singleton fetus with no anomalies, free of medical and obstetric complications.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Singleton pregnancy between 15 and 40 weeks gestational age.\n2. Sure of her date (well-known LMP or confirmed date by an early ultrasound).\n3. Normal fetal anatomy.\n4. No history of medical disorders.\n\nExclusion Criteria:\n\n1. Multiple pregnancy\n2. Fetal anomalies.\n3. Associated medical disorders.\n4. Obstetric complications.'}, 'identificationModule': {'nctId': 'NCT06761794', 'briefTitle': 'Normogram of Umbilical Artery and Fetal Middle Cerebral Artery Doppler Indices in Upper Egyptian Women', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Normogram of Umbilical Artery and Fetal Middle Cerebral Artery Doppler Indices in Upper Egyptian Women', 'orgStudyIdInfo': {'id': 'Doppler indices in normal preg'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Salma Kamel Bakhit, Graduate', 'role': 'CONTACT', 'email': 'salma0122858@gmail.com', 'phone': '0201094242196'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Salma Kamel Morsi Bakhit', 'investigatorAffiliation': 'Assiut University'}}}}