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Completed

NCT Number: NCT07186257

Impact of Uterine Leiomyoma Location on Uterine Artery Doppler Velocimetry

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Bakırköy Dr Sadi Konuk Eğitim ve Araştırma Hastanesi

Istanbul, bakırköy, 34147, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

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

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

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

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

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

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

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

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

Sponsors and collaborators

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Other Gov

Registry information

Official study title

Impact of Uterine Leiomyoma Location on Uterine Artery Doppler Velocimetry : a Prospective Cohort Study

Acronym: ULLADS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 22, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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