| 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
|
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
AIIMS Ansari nagar, New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N858||Other specified noninflammatory disorders of uterus, |
|
|
Intervention / Comparator Agent
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shivangisingh.ss.ns@gmail.com].
- 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.
- 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%ÂÂ3. It 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. |