Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-29 @ 11:39 AM
Study NCT ID:
NCT07186257
Status:
COMPLETED
Last Update Posted:
2025-09-22
First Post:
2025-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Uterine Leiomyoma Location on Uterine Artery Doppler Velocimetry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007889', 'term': 'Leiomyoma'}, {'id': 'D047708', 'term': 'Myofibroma'}], 'ancestors': [{'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 185}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2025-06-10', 'studyFirstSubmitQcDate': '2025-09-15', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the impact of uterine leiomyom location on uterine artery pulsatility index (PI)', 'timeFrame': 'The doppler measurement is performed at the enrollment of the first patient up to one year', 'description': 'The pulsatility index (PI) measurements compared amongst the study groups of different leiomyoma localizations (submucous, intramural, subserous) and control group'}, {'measure': 'the impact of uterine leiomyom location on uterine artery resistance index (RI)', 'timeFrame': 'The doppler measurement is performed at the enrollment of the first patient up to one year', 'description': 'The resistance index (RI) measurements compared amongst the study groups of different leiomyoma localizations (submucous, intramural, subserous) and control group'}, {'measure': 'the impact of uterine leiomyom location on uterine artery systolic/diastolic ratio (S/D)', 'timeFrame': 'The doppler measurement is performed at the enrollment of the first patient up to one year', 'description': 'The systolic/diastolic ratio measurements compared amongst the study groups of different leiomyoma localizations (submucous, intramural, subserous) and control group'}]}, 'conditionsModule': {'keywords': ['leiomyoma', 'uterine artery', 'doppler ultrasound', 'doppler velocimetry', 'uterine leiomyoma', 'leiomyoma location'], 'conditions': ['Leiomyoma (Uterine Fibroids)']}, 'descriptionModule': {'briefSummary': "Aim: Investigation of the impact of uterine leiomyoma location on uterine artery velocimetry Materials and Methods: It is a single-center prospective cohort study. The information regarding patients' demography, medical history, obstetric history, menstrual patterns, gynecological history, patients' complaints and physical examination recorded. For the patients who experience pain, visual analog scores were recorded. Total number of 185 patients have been administered for this study. They are further divided into four sub-groups according to the leiomyoma location. All measurements were recorded by the same doppler ultrasonography machine and same preset settings were used for each measurement. All examinations were performed by the same investigator. The measurements of uterus and myoma in ortogonal projections were recorded to calculate the volume by the prolate elipsoid formula. The location of each myoma were noted according to the FIGO classification. The recorded doppler ultrasonography indices included pulsatility index, resistance index and sistol/diastol ratio. IBM SPSS 27.0.0 was used for statistical analysis.\n\nResults: Mean values of PI, RI and S/D ratio were significantly lower in intramural myoma subgroup (p\\<0,01). The doppler parameters were significantly higher for submucousal myoma compared to intramural and subserous myoma groups (p\\<0,01) while there was no significant difference with control group. The impact of uterin leiomyoma location on uterin arter doppler findings were not altered by the effects of demographical features, age, BMI or history of c-section. The increased volumes of both uterus and myoma negatively correlated with the doppler indices while the history of c-section had a positive correlation with the doppler findings. The complaints of the patients at admission showed no effect on the doppler parameters.\n\nConclusion: The uterin leiomyoma location has been showed to be significant factor on uterin doppler velocimetry. The leiomyomas with intramural component significantly decreased the resistance in uterine artery. Further research is required to fully understand the underlying mechanism."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients who have appointments for the outpatient clinic of the hospital', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* being older than 18 years old\n* accepting the transvaginal ultrasound examination and having no impediment of having transvaginal ultrasound examination\n* premenopausal status\n* giving verbal and written consent to enroll\n* being in the follicular phase of the menstrual cycle\n\nExclusion Criteria:\n\n* being younger than 18 years old\n* pregnancy or postpartum status\n* postmenopausal status\n* being virgin\n* not accepting the transvaginal ultrasound examination or having an impeding condition\n* having a disease causing circulaiton abnormalities, cardiac diseases, or other comorbidities effecting circulation\n* diagnosed diabetes\n* taking any of the hormonal drugs (such as oral contraceptives, levonorgestrel realisng intrauterine devices)\n* diagnosed with any other gyneoclogical pathologies ( adenomyosis, endometriosis, adnexial masses, gynecologic malignancies, pelvic inflammatory diseases etc. )\n* being in the phases of menstrual cycle other than follicular phase\n* diagnosis with type 2-5 and type 8 leiomyoma uteri according to the FIGO classification\n* having multiple uterine leiomyomas\n* having a uterine leiomyoma larger than 500cm3'}, 'identificationModule': {'nctId': 'NCT07186257', 'acronym': 'ULLADS', 'briefTitle': 'Impact of Uterine Leiomyoma Location on Uterine Artery Doppler Velocimetry', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital'}, 'officialTitle': 'Impact of Uterine Leiomyoma Location on Uterine Artery Doppler Velocimetry : a Prospective Cohort Study', 'orgStudyIdInfo': {'id': '2024-11-17'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'submucous leiomyoma', 'description': 'patients who are diagnosed with submucous leiomyoma'}, {'label': 'intramural leiomyoma', 'description': 'patients who are diagnosed with intramural leiomyoma'}, {'label': 'subserous leiomyoma', 'description': 'patients who are diagnosed with subserous leiomyoma'}, {'label': 'control', 'description': 'patients in the control group'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34147', 'city': 'Istanbul', 'state': 'bakırköy', 'country': 'Turkey (Türkiye)', 'facility': 'Bakırköy Dr Sadi Konuk Eğitim ve Araştırma Hastanesi', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'İlke Esin Aydıner', 'investigatorAffiliation': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital'}}}}