Impact of Uterine Leiomyoma Location on Uterine Artery Doppler Velocimetry

NCT07186257 | Completed

• 1 other identifier: 2024-11-17
• Study Type: observational
• Target: 185
• Locations: 1 country
• Sites: 1

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)

Keywords

leiomyoma; uterine artery; doppler ultrasound; doppler velocimetry; uterine leiomyoma; leiomyoma location

Outcome Measures

Primary Outcomes (3)

• the impact of uterine leiomyom location on uterine artery pulsatility index (PI)

  The pulsatility index (PI) measurements compared amongst the study groups of different leiomyoma localizations (submucous, intramural, subserous) and control group

  The doppler measurement is performed at the enrollment of the first patient up to one year

• the impact of uterine leiomyom location on uterine artery resistance index (RI)

  The resistance index (RI) measurements compared amongst the study groups of different leiomyoma localizations (submucous, intramural, subserous) and control group

  The doppler measurement is performed at the enrollment of the first patient up to one year

• the impact of uterine leiomyom location on uterine artery systolic/diastolic ratio (S/D)

  The systolic/diastolic ratio measurements compared amongst the study groups of different leiomyoma localizations (submucous, intramural, subserous) and control group

  The doppler measurement is performed at the enrollment of the first patient up to one year

Study Arms (4)

submucous leiomyoma

patients who are diagnosed with submucous leiomyoma

intramural leiomyoma

patients who are diagnosed with intramural leiomyoma

subserous leiomyoma

patients who are diagnosed with subserous leiomyoma

control

patients in the control group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients who have appointments for the outpatient clinic of the hospital

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

Bakırköy Dr Sadi Konuk Eğitim ve Araştırma Hastanesi

Istanbul, bakırköy, 34147, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Leiomyoma; Myofibroma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Connective Tissue; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: September 22, 2025
• Study Start: October 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: June 4, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-06

Locations

TU (1)