Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-25 @ 7:35 AM
Study NCT ID:
NCT02995356
Status:
COMPLETED
Last Update Posted:
2019-03-28
First Post:
2016-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Axonemal Dynein Heavy Chain 5 and Creatine Kinase Concentration in Cervical Fluid for Early Detection of the Ectopic Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011271', 'term': 'Pregnancy, Ectopic'}], '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': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-26', 'studyFirstSubmitDate': '2016-12-12', 'studyFirstSubmitQcDate': '2016-12-13', 'lastUpdatePostDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentration of Axonemal Dynein Heavy Chain 5', 'timeFrame': '1 year'}, {'measure': 'Concentration of creatine kinase', 'timeFrame': '1 year'}]}, 'conditionsModule': {'keywords': ['Ectopic pregnancy', 'Axonemal Dynein Heavy Chain 5', 'Creatine Kinase', 'Cervical fluid'], 'conditions': ['Ectopic Pregnancy']}, 'referencesModule': {'references': [{'pmid': '33336538', 'type': 'DERIVED', 'citation': 'Sahin C, Uygun ZO, Hortu I, Akdemir A, Kocamanoglu M, Ergenoglu AM, Akcay Y. Using dynein heavy chain 5 and creatine kinase levels in cervical fluid and blood for early diagnosing of ectopic pregnancy. J Obstet Gynaecol Res. 2021 Mar;47(3):921-927. doi: 10.1111/jog.14616. Epub 2020 Dec 17.'}]}, 'descriptionModule': {'briefSummary': 'Patients who have doubt for ectopic pregnancy will be enrolled for our study. These patients will be determined with using irregular increased human chorionic gonadotropin (beta-HCG) results and no embryo reported ultrasonography results. Plasma and cervical fluid samples will be taken from these patients and axonemal dynein heavy chain 5 and creatine kinase levels of samples will be compared between patients who have doubt for ectopic pregnancy and patients who have intrauterine pregnancy. Concentration of these proteins in samples will be evaluated. If any difference will be found between groups in favour of ectopic pregnancy, these results might be interpreted as these proteins useful for early detecting of the ectopic pregnancy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have doubt for ectopic pregnancy will be selected for study group and patients who have intrauterine pregnancy will be selected for control group.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Doubted ectopic pregnancy\n* Without any finding about intrauterine pregnancy in ultrasonography results\n* Without any vaginal bleeding\n* Having irregular pregnancy test results\n* Beta-HCG results should be at least upper than 100 milli-International unit (mIU/ml)\n* Having fist trimester pregnancy for intrauterine pregnancy group\n* Without any emergency findings\n\nExclusion Criteria:\n\n* Doubted incomplete abortion\n* Having vaginal bleeding\n* Having ultrasound results which include intrauterine embryo report\n* Having lower than 100 mIU/ml beta-HCG results\n* Without fetal heart rate in intrauterine pregnancy group\n* Having older than fist trimester pregnancy for intrauterine pregnancy group\n* Having emergency findings'}, 'identificationModule': {'nctId': 'NCT02995356', 'briefTitle': 'Evaluation of the Axonemal Dynein Heavy Chain 5 and Creatine Kinase Concentration in Cervical Fluid for Early Detection of the Ectopic Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Ege University'}, 'orgStudyIdInfo': {'id': '2.101.2015.0076'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Doubt for ectopic pregnancy group', 'description': 'This group participants have doubt for ectopic pregnancy in terms of beta-HCG pregnancy follow-up results and ultrasonography results.', 'interventionNames': ['Other: Collecting cervical liquid and sera samples']}, {'label': 'Normal intrauterine pregnancy group', 'description': 'This groups participants have normal intrauterine pregnancy', 'interventionNames': ['Other: Collecting cervical liquid and sera samples']}], 'interventions': [{'name': 'Collecting cervical liquid and sera samples', 'type': 'OTHER', 'armGroupLabels': ['Doubt for ectopic pregnancy group', 'Normal intrauterine pregnancy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35100', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Ege University, Medicine Faculty, Department of Obstetrics and Gynecology', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ege University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Cagdas Sahin', 'investigatorAffiliation': 'Ege University'}}}}