Impact of Uterine Leiomyoma Location on Uterine Artery Doppler Velocimetry

NCT ID: NCT07186257

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 185 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-06-04

Brief Summary

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.

Results: 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.

Conclusion: 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.

Conditions

Leiomyoma (Uterine Fibroids)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

submucous leiomyoma

patients who are diagnosed with submucous leiomyoma

No interventions assigned to this group

intramural leiomyoma

patients who are diagnosed with intramural leiomyoma

No interventions assigned to this group

subserous leiomyoma

patients who are diagnosed with subserous leiomyoma

No interventions assigned to this group

control

patients in the control group

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• being older than 18 years old
• accepting the transvaginal ultrasound examination and having no impediment of having transvaginal ultrasound examination
• premenopausal status
• giving verbal and written consent to enroll
• being in the follicular phase of the menstrual cycle

Exclusion Criteria

• being younger than 18 years old
• pregnancy or postpartum status
• postmenopausal status
• being virgin
• not accepting the transvaginal ultrasound examination or having an impeding condition
• having a disease causing circulaiton abnormalities, cardiac diseases, or other comorbidities effecting circulation
• diagnosed diabetes
• taking any of the hormonal drugs (such as oral contraceptives, levonorgestrel realisng intrauterine devices)
• diagnosed with any other gyneoclogical pathologies ( adenomyosis, endometriosis, adnexial masses, gynecologic malignancies, pelvic inflammatory diseases etc. )
• being in the phases of menstrual cycle other than follicular phase
• diagnosis with type 2-5 and type 8 leiomyoma uteri according to the FIGO classification
• having multiple uterine leiomyomas
• having a uterine leiomyoma larger than 500cm3

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

İlke Esin Aydıner

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bakırköy Dr Sadi Konuk Eğitim ve Araştırma Hastanesi

Istanbul, bakırköy, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2024-11-17

Identifier Type: -

Identifier Source: org_study_id