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CTRI Number  CTRI/2023/12/060484 [Registered on: 04/12/2023] Trial Registered Prospectively
Last Modified On: 01/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   relation of clinical symptoms of pain and heavy menstrual bleeding in adenomyosis with ultrasound features as mentioned in revised Morphological Ultrasonographic Assessment (MUSA) features 
Scientific Title of Study   Correlation of clinical manifestations of adenomyosis with revised Morphological Ultrasonographic Assessment (MUSA) features. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shivangi Singh 
Designation  junior resident 
Affiliation  AIIMS New Delhi 
Address  Department of obstetrics and gynaecology 3rd floor, AIIMS New Delhi, Ansari nagar pin code 110029

New Delhi
DELHI
110029
India 
Phone  8006780705  
Fax    
Email  shivangisingh.ss.ns@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Juhi Bharti 
Designation  associate professor 
Affiliation  AIIMS New Delhi 
Address  Department of Obstetrics and Gynaecology 3rd floor, AIIMS New Delhi, Ansari nagar

New Delhi
DELHI
110029
India 
Phone  8527570849  
Fax    
Email  drjuhigeorgian.04@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Juhi Bharti 
Designation  associate professor 
Affiliation  AIIMS New Delhi 
Address  Department of Obstetrics and Gynaecology 3rd floor, AIIMS New Delhi, Ansari nagar

New Delhi
DELHI
110029
India 
Phone  8527570849  
Fax    
Email  drjuhigeorgian.04@gmail.com  
 
Source of Monetary or Material Support  
AIIMS New Delhi 
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  AIIMS Ansari nagar, New Delhi 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
SHIVANGI SINGH  AIIMS NEW DELHI  department of obstetrics and gynaecology , AIIMS New Delhi, Ansari nagar delhi
New Delhi
DELHI 
8006780705

shivangisingh.ss.ns@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institute ethics committee AIIMS New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N858||Other specified noninflammatory disorders of uterus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Patients presenting with symptoms of dysmenorrhea/HMB/ and
Diagnosed to have adenomyosis based on  1 ultrasound features of adenomyosis as per revised MUSA criteria

Willing to give informed written consent
 
 
ExclusionCriteria 
Details  Coexisting fibroid (Fibroid >5 cm or FIGO type 0,1,2)
Coexisting endometriosis
Women using contraceptives or taking hormonal medications within 3 months of recruitment
Not willing to give consent for the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Correlation of pain score (NRS4) with direct/indirect features, number of features, site and extent of adenomyosis
2. Correlation of total menstrual loss by PBAC(PBAC100) with direct/indirect features, number of features, site and extent of adenomyosis
 
patient assessment at a given point only, no follow up required
 
 
Secondary Outcome  
Outcome  TimePoints 
1. To correlate type of feature, number of features, site and extent of adenomyosis with quality of life  zero weeks 
 
Target Sample Size   Total Sample Size="107"
Sample Size from India="107" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   12/12/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  12/12/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [shivangisingh.ss.ns@gmail.com].

  6. For how long will this data be available start date provided 01-12-2025 and end date provided 01-12-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Adenomyosis is defined as a benign uterine pathology in which there is presence of endometrium glands and stroma in the myometrium1. It can either be a focal or a diffuse lesion in inner or outer myometrium. A classical histological definition for adenomyosis is the invasion of the myometrium by endometrial glands and/or stroma, deeper than 2.5 mm from the endometrial –myometrial junction, accompanied by adjacent smooth muscle hyperplasia. It is commonly found among the age group of 35-50 years2.The prevalence of adenomyosis is difficult to estimate due to the existence of asymptomatic variants and varied diagnostic techniques (histological or imaging). The prevalence is estimated to be on the order of 20-30% based on a series of patients treated by hysterectomy, however there is a significant degree of heterogeneity in this estimation, ranging from 5% to 70%­­3.

It[ss1]  is hard to associate one pathognomonic feature to the presence of adenomyosis.

Common symptoms associated with the condition can include pelvic pain (dysmenorrhea, dyspareunia, chronic pelvic pain), abnormal uterine bleeding and reduced reproductive potential. Although about 30% of the patients with adenomyosis are asymptomatic4. Traditionally it was diagnosed mainly on histological specimens obtained after surgical intervention. However, with recent advances in the field of non-invasive diagnostic tools, modalities like Magnetic Resonance Imaging (MRI) and Transvaginal Ultrasonography (TVUS) have made it possible to make diagnosis of adenomyosis, prior to surgical intervention. A consensus on the terminology to use when characterizing ultrasound pictures of adenomyosis was released in 2015 by the worldwide Morphological Uterus Sonographic Assessment (MUSA) group5. A standard categorization and reporting system for adenomyosis’s morphological variants and its ultrasound-based extent was proposed by the MUSA group in 20196. The definitions of MUSA features of adenomyosis were revised in 2022. The distinction between direct and indirect signs and its correlation with symptoms of adenomyosis like pain, bleeding and subfertility can help facilitate recognition and diagnosis of adenomyosis in clinical practice7.

The relation between direct and indirect MUSA characteristics of adenomyosis, as well as the correlation of disease location, extent, and size with clinical symptoms and therapeutic effects needs to be further evaluated using prospective studies.

Lack of prospective studies to link revised MUSA ultra-sonographic features with the clinical symptom forms the lacunae in the existing knowledge. Therefore, we aim to conduct a study to establish the correlation of one or more direct or indirect features of adenomyosis (as per revised MUSA definitions) and clinical outcomes as well as the association between number, size of features and their location (with relation to the junctional zone or layer of involvement) and clinical symptoms.

 


 [ss1]Prevalence, general, infertility

 
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