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临床试验/NCT07186257
NCT07186257已完成不适用

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

Bakirkoy Dr. Sadi Konuk Research and Training Hospital1 个研究点 分布在 1 个国家目标入组 185 人开始时间: 2024年10月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
185
试验地点
1
主要终点
the impact of uterine leiomyom location on uterine artery pulsatility index (PI)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 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

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

时间窗: 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

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

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

İlke Esin Aydıner

Doctor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

研究点 (1)

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