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:
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Organization:
Study Overview
Official Title:
Impact of Uterine Leiomyoma Location on Uterine Artery Doppler Velocimetry : a Prospective Cohort Study
Status:
COMPLETED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ULLADS
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: