Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:41 PM
Study NCT ID:
NCT06164067
Status:
COMPLETED
Last Update Posted:
2023-12-11
First Post:
2023-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Role of Cervical Consistency Index and Uterocervical Angles in Medical Termination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016595', 'term': 'Misoprostol'}], 'ancestors': [{'id': 'D011459', 'term': 'Prostaglandins E, Synthetic'}, {'id': 'D011465', 'term': 'Prostaglandins, Synthetic'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-01', 'studyFirstSubmitDate': '2023-04-04', 'studyFirstSubmitQcDate': '2023-12-01', 'lastUpdatePostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'success of predictivity cervical consistency index, anterior uterocervical angle and posterior uterocervical angle', 'timeFrame': '6 months', 'description': "cervical consistency index (CCI), an ultrasound measurement that aims to estimate cervical softness by measuring the anteroposterior diameter of the uterine cervix before (AP) (millimeter) and at maximal compression (AP') with the vaginal ultrasound probe and calculating the ratio between the two measurements (AP'/AP × 100). Uterocervical angle (UCA) (degree):Transvaginal sonographic images showing technique of measurement of uterocervical angle. UCA was calculated as angle between two lines. The first line was drawn between internal (I) and external ostium (os) (E). The second line was drawn 3 cm parallel to the lower aspect of anterior inner uterine wall passing through the end of the first line at internal os. (in degrees)"}], 'secondaryOutcomes': [{'measure': 'compare the measured ultrasonographic values', 'timeFrame': '6 months', 'description': 'compare the measured ultrasonographic values with the success of predictivity cervical length.( millimeter)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['medical termination', 'uterocervical angle', 'abortion', 'second trimester'], 'conditions': ['Second Trimester Abortion', 'Uterocervical Angle', 'Cervical Consistency Index']}, 'descriptionModule': {'briefSummary': 'The main aim of the investigator study is the success of predictivity cervical consistency index (CCI), anterior uterocervical angle (aUCA) and posterior uterocervical angle (pUCA) in second trimester terminations.', 'detailedDescription': 'This prospective clinical study includes 136 pregnant women with a diagnosis of in utero ex fetus who were hospitalized for medical termination in the gynecology service of Health Sciences University Bursa High Specialization Training and Research Hospital Gynecology and Obstetrics Clinic as a single center. The participants were divided into 2 groups as those whose treatment was completed in the first 24 hours (who were completely aborted and removed the fetal material and its attachments ) and those who aborted within 24-48 hours when additional cycles were needed. Furthermore who applied to additional treatment methods were recorded (cervical balloon, hysterotomy ) during these periods. In all pregnant women; characteristic features, abortion times, doses of misoprostol used, anterior- posterior uterocervical angle, cervical length, cervical consistency indexes and gestational weeks were saved.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'white people same demographics no socio- cultural difference', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women who had a termination indication in the second trimester and had abortion or abortion in our hospital\n* women who have had a miscarriage or abortion with a normal vaginal route or hysterotomy\n\nExclusion Criteria:\n\n* multiple pregnancies\n* pregnant women with misoprostol-related allergies\n* scar pregnancies or heterotopic pregnancies\n* patients with a history of previous conization or cervical surgery,\n* patients with placental invasion anomaly'}, 'identificationModule': {'nctId': 'NCT06164067', 'briefTitle': 'The Role of Cervical Consistency Index and Uterocervical Angles in Medical Termination', 'organization': {'class': 'OTHER', 'fullName': 'Sanliurfa Mehmet Akif Inan Education and Research Hospital'}, 'officialTitle': 'The Role of Cervical Consistency Index and Uterocervical Angles in Predicting Second Trimester Medical Termination', 'orgStudyIdInfo': {'id': '2011-KAEK-25 2022/04-52'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnant women who abort within 24 hours', 'description': 'Group 1 treatment was completed in the first 24 hours ( who were completely aborted and removed the fetal material and its attachments )', 'interventionNames': ['Other: abortus within 24 hours or 24-48 hours']}, {'label': 'Pregnant women who abort within 24- 48 hours', 'description': 'Group 2 consisted of patients who needed additional cycles and aborted within 24-48 hours.', 'interventionNames': ['Other: abortus within 24 hours or 24-48 hours']}], 'interventions': [{'name': 'abortus within 24 hours or 24-48 hours', 'type': 'OTHER', 'otherNames': ['misoprostol'], 'description': 'second trimester medical termination', 'armGroupLabels': ['Pregnant women who abort within 24 hours', 'Pregnant women who abort within 24- 48 hours']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16110', 'city': 'Bursa', 'country': 'Turkey (Türkiye)', 'facility': 'Nefise Nazlı YENIGUL', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanliurfa Mehmet Akif Inan Education and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph.D. Assistant Professor Department of Obstetrics and Gynecology', 'investigatorFullName': 'Nefise Nazlı YENIGUL', 'investigatorAffiliation': 'Sanliurfa Mehmet Akif Inan Education and Research Hospital'}}}}