Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-01-04 @ 7:21 PM
Study NCT ID:
NCT04456660
Status:
UNKNOWN
Last Update Posted:
2023-10-26
First Post:
2020-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comprehensive Assessment of Risks for Miscarriage.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000022', 'term': 'Abortion, Spontaneous'}], 'ancestors': [{'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': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-23', 'studyFirstSubmitDate': '2020-06-25', 'studyFirstSubmitQcDate': '2020-06-29', 'lastUpdatePostDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurence of a spontaneous abortion', 'timeFrame': 'Up to 24 weeks of gestation', 'description': 'Absent heart rate pulsations on an ultrasound scan'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spontaneous Abortion']}, 'descriptionModule': {'briefSummary': 'This study aims to determine the role of serum biomarkers and placental bloodflow in the comprehensive evaluation of the risk for spontaneous abortion', 'detailedDescription': 'To study the added value (if any) of combining serum markers, immunologic factors, and ultrasound parameters in comprehensively evaluating the risk for spontaneous abortion.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women between 18 and 50 years of age.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* visualized fetal structures in utero \\& heart pulsations until 8th week of gestation\n* normal THS/T4 levels\n* no uterine malformations\n* BMI \\< 27\n* signed informed consent\n\nExclusion Criteria:\n\n* fetal structures in utero \\& heart pulsations not visualized until the 8th week of gestation\n* elevated THS/T4 levels\n* uterine malformations\n* BMI \\> 27'}, 'identificationModule': {'nctId': 'NCT04456660', 'acronym': 'MIS-CARE', 'briefTitle': 'Comprehensive Assessment of Risks for Miscarriage.', 'organization': {'class': 'OTHER', 'fullName': 'Orthogyn Medical Center, Bulgaria'}, 'officialTitle': 'Markers of Ultrasound, Immunologic & Serum Factors in the Comprehensive Analysis of Risks for Early Pregnancy Loss.', 'orgStudyIdInfo': {'id': 'MIS-CARE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control group', 'description': 'Monitoring of pregnancy, including data on:\n\n* maternal age and other demographic characteristics;\n* ultrasound measurement of fetal heart rate (FHR) and crown-rump length (CRL)'}, {'label': 'sFlt-1, Doppler and NK cells types group', 'description': 'Monitoring of pregnancy, including data on:\n\n* maternal age and other demographic characteristics;\n* ultrasound measurement of fetal heart rate (FHR) and crown-rump length (CRL), uterine arteries PI, and other parameters;\n* measurement of serum sFlt-1, PLGF, and glycodelin-A levels, as well as other parameters;\n* measurement of CD16+, CD56+, and other subpopulations of NK cells;', 'interventionNames': ['Diagnostic Test: Markers of ultrasound', 'Diagnostic Test: Immunologic factors', 'Diagnostic Test: Serum factors']}], 'interventions': [{'name': 'Markers of ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'CRL, HR, and other ultrasound measurements.', 'armGroupLabels': ['sFlt-1, Doppler and NK cells types group']}, {'name': 'Immunologic factors', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measurement of NK cells subpopulations types in the maternal serum', 'armGroupLabels': ['sFlt-1, Doppler and NK cells types group']}, {'name': 'Serum factors', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measuring the maternal serum concentration of sFlt-1, PLGF, glycodelin-A, and other substances.', 'armGroupLabels': ['sFlt-1, Doppler and NK cells types group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1618', 'city': 'Sofia', 'status': 'RECRUITING', 'country': 'Bulgaria', 'contacts': [{'name': 'Petar D Ignatov, PhD', 'role': 'CONTACT', 'email': 'ignatov@orthogyn.com', 'phone': '00359888963189', 'phoneExt': '00359'}], 'facility': 'Orthogyn Medical and Dental Center', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}], 'centralContacts': [{'name': 'Petar N Ignatov, PhD', 'role': 'CONTACT', 'email': 'ignatov@orthogyn.com', 'phone': '0035988896318', 'phoneExt': '00359'}], 'overallOfficials': [{'name': 'Petar N Ignatov, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orthogyn Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Orthogyn Medical Center, Bulgaria', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assist. Prof. Petar Ignatov, MD, Ph.D.', 'investigatorFullName': 'Petar Ignatov', 'investigatorAffiliation': 'Orthogyn Medical Center, Bulgaria'}}}}