Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-01-03 @ 10:04 AM
Study NCT ID:
NCT03214393
Status:
UNKNOWN
Last Update Posted:
2017-07-11
First Post:
2017-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Certain Maternal Antibodies in Relation to Doppler in Hypertension With Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}], 'ancestors': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015150', 'term': 'Echocardiography, Doppler'}], 'ancestors': [{'id': 'D004452', 'term': 'Echocardiography'}, {'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D018608', 'term': 'Ultrasonography, Doppler'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2018-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-10', 'studyFirstSubmitDate': '2017-07-10', 'studyFirstSubmitQcDate': '2017-07-10', 'lastUpdatePostDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percentage of cases that develop severe pre-eclampsia', 'timeFrame': 'It will be calculated after 1 year from the start of the study', 'description': 'percentage of cases that develop severe pre-eclampsia will be assessed by an investigator'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pre-Eclampsia']}, 'descriptionModule': {'briefSummary': 'Relation of certain maternal serum antibodies to Doppler changes will be studied in cases suffering from hypertension with pregnancy.', 'detailedDescription': 'Assessment will be done for maternal serum anti-beta 2 glycoprotein 1 antibodies and anticardiolipin antibodies in cases of preeclampsia after 32 weeks of pregnancy. In addition, fetal Doppler changes will be assessed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant females 32 weeks gestation or more with pre-eclampsia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women 32 weeks or more gestational age\n* Pre-eclampsia\n* Singleton pregnancy\n\nExclusion Criteria:\n\n* Intrauterine fetal death\n* Fetus with apparent congenital anomalies\n* Pregnant females with other medical disorders\n* History of essential hypertension.\n* History of antepartum hemorrhage.\n* History of rupture of membranes.'}, 'identificationModule': {'nctId': 'NCT03214393', 'briefTitle': 'Certain Maternal Antibodies in Relation to Doppler in Hypertension With Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Role of Maternal Anticardiolipin and Anti-B2 Glycoprotein I Antibodies in Correlation With Fetal Doppler in Prediction of Adverse Pregnancy Outcome in Patients With Preeclampsia', 'orgStudyIdInfo': {'id': '3650'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pre-Eclampsia', 'description': 'pregnant women with Pre-Eclampsia will be assessed by serum antibodies and Doppler', 'interventionNames': ['Diagnostic Test: Doppler', 'Diagnostic Test: serum antibodies']}], 'interventions': [{'name': 'Doppler', 'type': 'DIAGNOSTIC_TEST', 'description': 'Doppler will be done to pregnant women with Pre-Eclampsia', 'armGroupLabels': ['Pre-Eclampsia']}, {'name': 'serum antibodies', 'type': 'DIAGNOSTIC_TEST', 'description': 'serum antibodies will be measured for pregnant women with Pre-Eclampsia', 'armGroupLabels': ['Pre-Eclampsia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11956', 'city': 'Cairo', 'state': 'Greater Cairo', 'country': 'Egypt', 'contacts': [{'name': 'Doaa Belal, MD', 'role': 'CONTACT', 'email': 'doaash@live.com', 'phone': '0020223682030'}], 'facility': 'Department of Obstetrics and Gynecology', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Doaa Sh Belal, MD', 'role': 'CONTACT', 'email': 'doaash@live.com', 'phone': '0020223682030'}], 'overallOfficials': [{'name': 'Doaa Sh Belal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo U'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Doaa Shafie Belal', 'investigatorAffiliation': 'Cairo University'}}}}