Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2025-12-26 @ 12:16 PM
Study NCT ID:
NCT06558500
Status:
COMPLETED
Last Update Posted:
2024-08-20
First Post:
2024-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Uterocervical Angle Versus Cervical Length as a Predictor of Labor Induction in Term Singleton Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}, 'targetDuration': '2 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-16', 'studyFirstSubmitDate': '2024-08-14', 'studyFirstSubmitQcDate': '2024-08-14', 'lastUpdatePostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The efficacy of uterocervical angle', 'timeFrame': '2 days', 'description': 'The efficacy of uterocervical angle in predicting labor induction success in nulliparous patients at term.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nulliparous', 'labor induction', 'posterior cervical angle', 'uterocervical angle', 'cervical length'], 'conditions': ['Labor (Obstetrics)--Complications']}, 'descriptionModule': {'briefSummary': 'Induction of labor is frequently performed in all obstetric clinics. Failed IOL has been defined in many different ways.Bishop scoring, which is a traditional and subjective method, is more frequently evaluated with cervical length, which has taken its place in preterm labor, and various ultrasonographic evaluations such as Uterocervical angle (UCA), Posterior cervical angle (PCA), cervical elastography, transvulvar ultrasonography, which have recently increased in popularity, have gained importance and led us to evaluate these parameters in our clinic. The relationship between the angles between the uterus and cervix and labor has been known for some time.', 'detailedDescription': 'Induction of labor is frequently performed in all obstetric clinics for various indications, with a worldwide spectrum ranging from 1.4 to 35%. Failed IOL has been defined in many different ways. It has been defined as a dilatation of less than 4 cm despite administration of oxytocin for 12 hours±3 hours (target 200-225 MVU or 3 contractions/10 min), induction of labor with oxytocin for at least 12-18 hours (after rupture of membranes) and a latent phase lasting 24 hours or longer, primarily considering fetal and maternal well-being. In some sources, it is defined as failure to achieve regular (e.g. every 3 minutes) uterine contractions and cervical changes with artificial rupture of membranes after at least 6-8 hours of oxytocin maintenance dose. For this reason, various subjective \\& ultrasonographic parameters used to predict induction success are of great importance for the evaluation of the cervix. Bishop scoring, which is a traditional and subjective method, is more frequently evaluated with cervical length, which has taken its place in preterm labor, and various ultrasonographic evaluations such as Uterocervical angle (UCA), Posterior cervical angle (PCA), cervical elastography, transvulvar ultrasonography, which have recently increased in popularity, have gained importance and led us to evaluate these parameters in our clinic.\n\nThe relationship between the angles between the uterus and cervix and labor has been known for some time.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This prospective observational study was conducted at the Department of Obstetrics and Gynecology, Ankara Etlik Hospital, between June 2024 and August 2024, on 140 term pregnancies admitted for maternal or fetal reasons , planned for labor induction.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n37 weeks and older Nulliparity Live, singular Verteks presentation Cervical opening\\<3 cm Bishop score\\<7 Patients not in active action\n\nExclusion Criteria:\n\n* Presence of contraindications to vaginal delivery (pls previa, detached pls...)\n* History of previous uterine surgery\n* Multiple pregnancies\n* Non-vertex presentation\n* Uncontrolled HT Uncontrolled DM\n* Fetal distress\n* Macrosomic fetus Patients in active labor'}, 'identificationModule': {'nctId': 'NCT06558500', 'briefTitle': 'Uterocervical Angle Versus Cervical Length as a Predictor of Labor Induction in Term Singleton Pregnancy', 'organization': {'class': 'OTHER', 'fullName': "Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital"}, 'officialTitle': "Uterocervical and Posterior Cervical Angle Versus Cervical Length and Bishop's Score as a Predictor of Labor Induction in Term Singleton Pregnancy: a Prospective Study", 'orgStudyIdInfo': {'id': '2022/113'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'group 1', 'description': 'delivered vaginally with successful induction of labor', 'interventionNames': ['Procedure: Uterocervical angle']}, {'label': 'group 2', 'description': 'failed induction and delivered with C/S', 'interventionNames': ['Procedure: Uterocervical angle']}], 'interventions': [{'name': 'Uterocervical angle', 'type': 'PROCEDURE', 'otherNames': ['Posterior cervical angle'], 'description': 'With the patient in the lithotomy position and empty bladder, care was taken to avoid applying pressure to the cervix with the transvaginal probe. The cervix was aligned in the midline, and the endocervical canal was visualized throughout its length.During cervical measurement, care was taken to ensure that the internal os, external os, and entire endocervical canal were visible in the same image. With the endocervical canal, external os, and internal os linearly displayed on the screen, the angle between the endocervical canal, anterior and posterior uterine segment was measured using the ultrasound\'s "angle measurement" feature.For the measurement of the uterocervical angle, the first line of the angle was defined along the endocervical canal used for measuring cervical length, and the second line was drawn from the internal os along the anterior uterine segment for a minimum of two centimeters. The angle between these two lines was recorded as the uterocervical angle in the form.', 'armGroupLabels': ['group 1', 'group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': "Etlik Zubeyde Hanım Women's Health Education Hospital", 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Ali Turhan ÇAĞLAR', 'role': 'STUDY_CHAIR', 'affiliation': 'Etlik Zübeyde Hanım EAH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical doctor, Specialist of gynecology and obstetrics', 'investigatorFullName': 'Ayse Gizem Yildiz', 'investigatorAffiliation': "Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital"}}}}