Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-29 @ 12:39 PM
Study NCT ID:
NCT05513768
Status:
COMPLETED
Last Update Posted:
2022-11-23
First Post:
2022-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PRETERM DELİVERY and MYOCINE BINDING PROTEIN C LEVELs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'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': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-18', 'studyFirstSubmitDate': '2022-08-22', 'studyFirstSubmitQcDate': '2022-08-22', 'lastUpdatePostDateStruct': {'date': '2022-11-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'detection of prediction value of serum mbpc levels in preterm delivery', 'timeFrame': '10 mounths', 'description': 'identifying prediction value of first trmester serum mbpc levels by comparing by serum levels of mbpc in groups'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PRETERM DELİVERY, MBPC,'], 'conditions': ['Preterm']}, 'descriptionModule': {'briefSummary': 'IT WAS AIMED TO EVALUATE IF MBPC CAN BE USED IN PREDICTION OF EARLY BIRTH. TAKING THE FIRST TRIMESTER FROM PREGNANCY WAS STORED UNTIL THE TIMING OF DELIVERY.THE PARTICIPANTS WERE SEPARATED INTO TWO GROUPS ACCORDING TO THE TIME OF BIRTH, EARLY AND TIMELY.\n\nSERUM MBPC LEVELS BETWEEN TWO GROUPS EVALUATED.', 'detailedDescription': 'IT WAS AIMED TO EVALUATE IF MBPC CAN BE USED IN PREDICTION OF EARLY BIRTH. TAKING THE FIRST TRIMESTER FROM PREGNANCY WAS STORED UNTIL THE TIMING OF DELIVERY.THE PARTICIPANTS WERE SEPARATED INTO TWO GROUPS ACCORDING TO THE TIME OF BIRTH, EARLY AND TIMELY.\n\nSERUM MBPC LEVELS BETWEEN TWO GROUPS EVALUATED.A TOTAL OF 90 WOMEN WERE PLANNED TO INCLUDE 45 STUDY 45 CONTROL GROUP IN THE STUDY.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Includes participants whose serum samples were collected in the first trimester, stored, and then divided into two according to timing of delivery fırst grup ıs preterm group, and second one ıs those who gave birth on time', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* being pregnant in the first trimester\n* be between 18-40 years old\n\nExclusion Criteria:\n\n* no history of preterm birth\n* being pregnant with assisted reproductive techniques\n* having a multiple pregnancy\n* have cervical insufficiency'}, 'identificationModule': {'nctId': 'NCT05513768', 'briefTitle': 'PRETERM DELİVERY and MYOCINE BINDING PROTEIN C LEVELs', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Gaziosmanpasa Research and Education Hospital'}, 'officialTitle': 'Can First Trimester Serum Myocine Binding Protein c Level Predict Preterm Birth', 'orgStudyIdInfo': {'id': 'GaziosmanpasaTREHKHD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'women who gave birth prematurely', 'description': 'women who had serum taken in the first trimester and gave birth earlier than 37 weeks according to the time of delivery', 'interventionNames': ['Diagnostic Test: level of myosin binding protein c in serum']}, {'label': 'those who gave birth on time', 'description': 'women who have had serum taken in the first trimester, stored and delivered on time', 'interventionNames': ['Diagnostic Test: level of myosin binding protein c in serum']}], 'interventions': [{'name': 'level of myosin binding protein c in serum', 'type': 'DIAGNOSTIC_TEST', 'description': 'Serum samples will be taken from the participants in the first trimester, transferred to eppendorf tubes after appropriate procedures, and stored at -80 degrees until the time of deliveryParticipants will be divided into two groups according to the timing of birthThe first group is those who gave birth earlier than 37 weeks those who gave birth on time in the other group The mbpc levels will be looked at and compared.', 'armGroupLabels': ['those who gave birth on time', 'women who gave birth prematurely']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32225', 'city': 'Istanbul', 'state': 'Gaziosmanpaşa', 'country': 'Turkey (Türkiye)', 'facility': 'Gaziosmanpasa Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'elif yıldız', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gaziosmanpasa Research and Education Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gaziosmanpasa Research and Education Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MEDİCAL DOCTOR', 'investigatorFullName': 'Elif Yıldız', 'investigatorAffiliation': 'Gaziosmanpasa Research and Education Hospital'}}}}