Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-30 @ 11:04 AM
Study NCT ID:
NCT06915051
Status:
COMPLETED
Last Update Posted:
2025-11-18
First Post:
2025-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relationship Between Umbilical Cord Coiling Index and Fetal Cardiac Functions.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010547', 'term': 'Persistent Fetal Circulation Syndrome'}], 'ancestors': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 202}, 'targetDuration': '4 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-16', 'studyFirstSubmitDate': '2025-03-25', 'studyFirstSubmitQcDate': '2025-04-03', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The correlation between the fetal umbilical cord coiling number and the concurrently performed fetal echocardiography findings.', 'timeFrame': 'The correlation between the fetal umbilical cord coiling index and the echocardiographic findings of the fetus within the first hour will be investigated.', 'description': "This study will be a single-center study conducted on two hundred randomly selected pregnant women with uncomplicated singleton pregnancies in the late second trimester (20-24 weeks) who visit our hospital's perinatology outpatient clinic for routine prenatal check-ups. The umbilical cord coiling number and fetal cardiac function measurements will be performed within one hour by the same maternal-fetal medicine specialist.To optimize the quality of Doppler waveforms when assessing vascular structures, measurements will be obtained in the absence of uterine contractions and fetal activity, with an insonation angle as close to zero as possible and less than 30.Three parameters will be used to assess cardiac function:\n\n1. Diastolic function\n2. Systolic function\n3. Both systolic and diastolic function"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Umbilical cord coiling index', 'fetal cardiac functions', 'umbilical cord', 'fetal circulation'], 'conditions': ['Umbilical Cord Coiling Index and Fetal Cardiac Functions']}, 'descriptionModule': {'briefSummary': 'The maximum efficiency of umbilical cord blood flow depends on a specific number of coils. With modern ultrasound techniques, investigators can now detect cord abnormalities even before birth. In recent years, there has been a renewed interest in the umbilical cord, and several articles have been published regarding the number of coils.In this study, the relationship between the umbilical cord coiling index and fetal cardiac functions was evaluated.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Singleton uncomplicated pregnancies between 20-24 weeks seeking routine antenatal care will be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Singleton uncomplicated pregnancies between 20-24 weeks seeking routine antenatal care.\n\nExclusion Criteria:\n\n* Multiple pregnancy\n* Preterm rupture of membranes\n* Chorioamnionitis\n* Placental abruption\n* Severe fetal growth restriction\n* Congenital anomalies of the fetus\n* Preeclampsia\n* Oligohydramnios\n* Maternal diabetes.'}, 'identificationModule': {'nctId': 'NCT06915051', 'briefTitle': 'The Relationship Between Umbilical Cord Coiling Index and Fetal Cardiac Functions.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sanliurfa Education and Research Hospital'}, 'officialTitle': 'Evaluation of the Relationship Between Umbilical Cord Coiling Index and Fetal Cardiac Functions.', 'orgStudyIdInfo': {'id': 'SEAH-COİLİNG'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'This is a single-center study conducted on 200 randomly selected pregnant women with uncomplicated.', 'interventionNames': ['Diagnostic Test: Determining the relationship between the coiling number and fetal echocardiography findings.']}], 'interventions': [{'name': 'Determining the relationship between the coiling number and fetal echocardiography findings.', 'type': 'DIAGNOSTIC_TEST', 'description': 'Fetal echocardiography findings to be performed simultaneously with the determination of the coiling number.', 'armGroupLabels': ['This is a single-center study conducted on 200 randomly selected pregnant women with uncomplicated.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sanliurfa', 'country': 'Turkey (Türkiye)', 'facility': 'Sanliurfa Education and Research Hospital', 'geoPoint': {'lat': 37.16708, 'lon': 38.79392}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanliurfa Education and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}