Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2025-12-25 @ 10:09 PM
Study NCT ID:
NCT06381258
Status:
COMPLETED
Last Update Posted:
2024-12-24
First Post:
2024-04-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fetal Cardiac Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005317', 'term': 'Fetal Growth Retardation'}], 'ancestors': [{'id': 'D005315', 'term': 'Fetal Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006130', 'term': 'Growth Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019220', 'term': 'High-Energy Shock Waves'}], 'ancestors': [{'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-19', 'studyFirstSubmitDate': '2024-04-19', 'studyFirstSubmitQcDate': '2024-04-23', 'lastUpdatePostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac systolic function', 'timeFrame': '4 months', 'description': 'Measurement of ejection fraction in percent % (high is good, low is bad)'}], 'secondaryOutcomes': [{'measure': 'Cardiac diastolic function', 'timeFrame': '4 months', 'description': 'Measurement of spherity index ( high is bad, low is good)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fetal Growth Retardation']}, 'descriptionModule': {'briefSummary': 'The aim of our study is to evaluate the effect of PE and FGR on fetal cardiac function. Pregnancies with preeclampsia and FGR, and preeclampsia with normal fetal growth are evaluated by echocardiography and compared with uncomplicated pregnancies.', 'detailedDescription': 'Preeclampsia (PE) represent a major concern in public health, affecting 2-8% of all pregnancies and considered one of the leading causes of perinatal morbidity and mortality. Fetal growth restriction (FGR) ia also a common health problem affecting about 5-10% of all pregnancies and commonly associates with preeclampsia . It is estimated that 20% of cases of PE present with FGR and about 50% of early-onset FGR cases will eventually coexist with PE .\n\nBoth syndromes share some pathophysiologic features, with a variable involvement of placental insufficiency and cause fetal cardiovascular remodeling and adaptations . Fetal adaptations as metabolic and cardiovascular programming occur in response to adverse intrauterine conditions as PE and FGR . Offspring from preeclamptic pregnancies showed cardiac structural and functional changes and greater blood pressure in childhood and adolescence .\n\nMost of the studies on FGR included pregnancies complicated by PE and vice versa, which fails to adequately assess the independent effect of each condition on the fetal cardiac functions.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Group A : patients with preeclampsia (either with FGR or normal growth) Group B : patients without preeclampsia (16 cases)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Pregnant women more than or equals 28 weeks\n* Preeclampsia defined as systolic blood pressure 140 mm Hg and/or diastolic blood pressure 90 mm Hg\n* Fetus with normal growth or with growth restriction\n\nExclusion criteria:\n\n* congenital malformations\n* intrauterine infection\n* multiple pregnancies\n* fetuses of mothers treated with a tocolytic agent\n* fetuses with abnormal heart rates (tachycardia or bradycardia)'}, 'identificationModule': {'nctId': 'NCT06381258', 'briefTitle': 'Fetal Cardiac Function', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Fetal Systolic and Diastolic Cardiac Function Assessment in Mothers with Preeclampsia', 'orgStudyIdInfo': {'id': 'SDF'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with preeclampsia', 'description': 'Fetal ultrasound( echocardiography).Measurements will be performed using conventional pulsed-wave Doppler and M mode cross sectional image of the fetal thorax at the level of the 4-chamber view with an apical projection of the heart is obtained. Measurements of the ventricle at diastole and systole are obtained, and using the relationship between these measurements, calculations are performed to determine the ejection fraction (EF) (\\[diastole measurement-systole measurement\\]/diastole) measurement and shortening fraction ( SF) for both right \\& left ventricles.\n\nAssessment of ventricular diastolic function through measuring E-wave (early ventricular filling) and A wave (active atrial contraction - late ventricular filling) peak velocities and the ratio between them (E/A ratio) as an index will be performed for both mitral valve (MV) and tricuspid valve (TV)', 'interventionNames': ['Procedure: Ultrasound']}, {'label': 'Patients without preeclampsia', 'description': 'Fetal ultrasound (echocardiography).Measurements will be performed using conventional pulsed-wave Doppler and M mode cross sectional image of the fetal thorax at the level of the 4-chamber view with an apical projection of the heart is obtained. Measurements of the ventricle at diastole and systole are obtained, and using the relationship between these measurements, calculations are performed to determine the ejection fraction (EF) (\\[diastole measurement-systole measurement\\]/diastole) measurement and shortening fraction ( SF) for both right \\& left ventricles.\n\nAssessment of ventricular diastolic function through measuring E-wave (early ventricular filling) and A wave (active atrial contraction - late ventricular filling) peak velocities and the ratio between them (E/A ratio) as an index will be performed for both MV and TV', 'interventionNames': ['Procedure: Ultrasound']}], 'interventions': [{'name': 'Ultrasound', 'type': 'PROCEDURE', 'description': 'Fetal echocardiography using ultrasound device', 'armGroupLabels': ['Patients with preeclampsia', 'Patients without preeclampsia']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': "Women's Health Hospital", 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Obs& Gyn. Specialist of Urogynecology', 'investigatorFullName': 'Mohamed Gamal M.fekry', 'investigatorAffiliation': 'Assiut University'}}}}