Evaluation of the Relationship Between Adenomyosis and Elastographic Properties of the Cervix

NCT06223464 | Unknown

• 1 other identifier: AESH-EK1-2023-630
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the potential of cervical elastography, a non-invasive method, in the accurate diagnosis and clinical course of adenomyosis. Cervical elastography is an imaging method that measures the elasticity properties of cervical tissue using ultrasound technology. This method may be helpful in providing information about the development and clinical course of adenomyosis.

Conditions

Adenomyosis

Keywords

adenomyosis; elastography; cervical

Outcome Measures

Primary Outcomes (1)

• Diagnosis of Adenomyosis

  MUSA Criteria

  2 months

Secondary Outcomes (1)

• Diagnosis of Adenomyosis-Cervical Elastography

  4 months

Study Arms (2)

Adenomyosis-Case Group

The study will include those diagnosed with adenomyosis who were evaluated by gynecological examination and ultrasonographic imaging after the application to Etlik City Hospital Gynecology and Obstetrics Clinic, aged 18-45 reproductive period, pregnancy status excluded, without cervical infection, pathology and anomaly, without systemic disease findings and diagnoses, without chronic drug use.

Healthy patients-Control

The study will include those who have been gynecologically examined and evaluated with ultrasonographic imaging after the application to Etlik City Hospital Gynecology and Obstetrics Clinic, aged 18-45 reproductive period, pregnancy status excluded, without cervical infection, pathology and anomaly, without systemic disease findings and diagnoses, without chronic drug use, without adenomyosis diagnosis.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study will be included in our study as two case groups with and without the diagnosis of adenomyosis, whose age is 18-45 reproductive period, pregnancy status is excluded, without cervical infection, pathology and anomaly, without systemic disease findings and diagnoses, without chronic drug use, whose gynecological examination was performed and evaluated by ultrasonographic imaging after the application to Etlik City Hospital Gynecology and Obstetrics Clinic. MUSA criteria will be used in the diagnosis of adenomyosis and elastography measurements in kPa will be performed similar to the studies in the literature examples section in the file.

You may qualify if:

• Female patients between 18-45 years of age who volunteered and consented to the reproductive period study
• Patients diagnosed with adenomyosis using MUSA criteria

You may not qualify if:

• Pregnancy status
• Pelvic/Cervical infection, pathology and anomalies
• History of cervical surgery
• Diagnosis and findings of systemic disease
• Chronic drug use
• Advanced maternal obesity preventing measurement

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Yenimahalle, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Adenomyosis

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

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

Study Record Dates

• First Submitted: January 13, 2024
• First Posted: January 25, 2024
• Study Start: October 18, 2023
• Primary Completion: December 18, 2023
• Study Completion: April 18, 2024
• Last Updated: January 25, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)