Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-01-09 @ 8:46 AM
Study NCT ID:
NCT06390202
Status:
COMPLETED
Last Update Posted:
2024-04-30
First Post:
2024-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Uterine Artery Diastolic Notching & Apelin-13 and 36
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-25', 'studyFirstSubmitDate': '2024-04-22', 'studyFirstSubmitQcDate': '2024-04-25', 'lastUpdatePostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relationship between diastolic notching on uterine artery Doppler and serum apelin-13 and apelin-36 concentrations.', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Relationship between diastolic notching on uterine artery Doppler and serum apelin-13 and apelin-36 concentrations.'}, {'measure': 'Relationship between high pulsatility index on uterine artery Doppler and serum apelin-13 and apelin-36 concentrations.', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Relationship between high pulsatility index on uterine artery Doppler and serum apelin-13 and apelin-36 concentrations.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['uterine artery', 'apelin-13', 'apelin-36', 'Doppler'], 'conditions': ['Diagnosis']}, 'descriptionModule': {'briefSummary': 'This study was conducted to investigate the relationship between diastolic notching on uterine artery Doppler and serum apelin-13 and 36 concentrations between 11 and 14 weeks of gestation.', 'detailedDescription': "Apelin-13 and apelin-36, which provide vasodilatation through a nitric oxide-dependent mechanism, also play a role in trophoblasts' survival, proliferation, and migration.\n\nBased on this, we aimed to investigate serum apelin-13 and apelin-36 concentrations in pregnant women with and without diastolic notch on uterine artery Doppler between the 11th and 14th weeks of pregnancy.\n\nWe hypothesized that apelin-13 and apelin-36 might be associated with the formation of diastolic notch in uterine artery Doppler and serum apelin-13 and apelin-36 concentrations would be lower in the group with a notch in the uterine artery Doppler than in the group without a notch."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '44 singleton pregnant women with unilateral or bilateral diastolic notching detected in uterine artery Doppler between the 11th and 14th weeks of pregnancy formed the study group (uterine artery notch positive group). 44 singleton pregnant women who did not have diastolic notching in uterine artery Doppler between the 11th and 14th weeks of pregnancy constituted the control group (uterine artery notch negative group).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Nonsmokers,\n2. Singleton pregnancies between 11 and 14 weeks of gestation\n3. Pregnant women who did not conceive with assisted reproductive methods\n\nExclusion Criteria:\n\n1. Smokers\n2. Pregnant women who conceived with assisted reproductive techniques\n3. Pregnant women with multiple pregnancies\n4. Pregnant women who started with multiples and continued with singletons\n5. Pregnant women with any pregestational disease, thrombophilia\n6. Pregnant women with any congenital uterine anomaly\n7. Pregnant women with a history of recurrent pregnancy loss\n8. Pregnant women using aspirin or heparin'}, 'identificationModule': {'nctId': 'NCT06390202', 'briefTitle': 'Uterine Artery Diastolic Notching & Apelin-13 and 36', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Umraniye Education and Research Hospital'}, 'officialTitle': 'Investigation of the Relationship Between Uterine Artery Doppler Diastolic Notching and Serum Apelin-13 and Apelin-36 Concentrations Between the 11th and 14th Weeks of Pregnancy', 'orgStudyIdInfo': {'id': 'B.10.1.TKH.4.34.H.GP.0.01/31'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Uterine artery notch negative group', 'description': 'Pregnant women who did not have diastolic notching in uterine artery Doppler between the 11th and 14th weeks of pregnancy constituted the uterine artery notch negative group.', 'interventionNames': ['Other: no intervention']}, {'label': 'Uterine artery notch positive group', 'description': 'Pregnant women with unilateral or bilateral diastolic notching detected in uterine artery Doppler between the 11th and 14th weeks of pregnancy formed the uterine artery notch positive group.', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'there is no intervention in this study', 'armGroupLabels': ['Uterine artery notch negative group', 'Uterine artery notch positive group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34764', 'city': 'Istanbul', 'state': 'Ümraniye', 'country': 'Turkey (Türkiye)', 'facility': 'Ümraniye Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'İbrahim Kale, Associate professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Umraniye Education and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Umraniye Education and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'ibrahim kale', 'investigatorAffiliation': 'Umraniye Education and Research Hospital'}}}}