| CTRI Number |
CTRI/2024/05/067675 [Registered on: 20/05/2024] Trial Registered Prospectively |
| Last Modified On: |
04/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To assess relationship between CA125 and dysmenorrhea and menorrhagia in adenomyosis |
|
Scientific Title of Study
|
The value of CA 125 as a biomarker for assessing the severity of Dysmenorrhea
and Menorrhagia in Adenomyosis |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sutanka Sujaini |
| Designation |
Junior resident |
| Affiliation |
Kasturba Hospital, Manipal |
| Address |
Department of Obstetrics and Gynaecology
Kasturba Hospital
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9148844558 |
| Fax |
|
| Email |
sutanka.kmcmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayaraman Nambiar |
| Designation |
Professor |
| Affiliation |
Kasturba Hospital, Manipal |
| Address |
Department of Obstetrics and Gynaecology
Kasturba Hospital
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
919845082923 |
| Fax |
|
| Email |
drram.nambiar@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sutanka Sujaini |
| Designation |
Junior resident |
| Affiliation |
Kasturba Hospital, Manipal |
| Address |
Department of Obstetrics and Gynaecology
Kasturba Hospital
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9148844558 |
| Fax |
|
| Email |
sutanka.kmcmpl2023@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Manipal, Udupi, Karnataka, India, Pin code-576104 |
|
|
Primary Sponsor
|
| Name |
Dr Sutanka Sujaini |
| Address |
Department of Obstetrics and Gynaecology
Kasturba Hospital, Manipal, Udupi, Karnataka, India, Pin code-576104 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Sutanka sujaini |
Kasturba Hospital Manipal |
Ground floor, Women and Child block, Department of Obstetrics and Gynecology, Kasturba hospital Manipal
Udupi
KARNATAKA |
9148844558
sutanka.kmcmpl2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N946||Dysmenorrhea, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
-Females belonging to menstrual age group who understand and give informed consent
- Diagnosed with Adenomyosis based on USG findings using MUSA’s criteria and having symptoms of dysmenorrhea or menorrhagia
- Patients with above symptoms who have been given CA125 test. |
|
| ExclusionCriteria |
| Details |
- Patient who have not consented for the study.
- Patients diagnosed with gynecological malignancies |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
VAS Score
Pictorial Blood Loss Assessment Chart (PBAC)
The association between CA 125 and Menorrhagia or Dysmenorrhea will be analysed and the impact of focal vs diffuse adenomyosis will be assessed.
|
Baseline, 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the factors affecting CA125.
To study diffuse vs focal type of adenomyosis and its relation with CA125
levels
The association between CA 125 and Menorrhagia or Dysmenorrhea will be analysed and the impact of focal vs diffuse adenomyosis will be assessed.
|
Over 2 years duration |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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)
|
30/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/05/2024 |
| 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)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
- After approval from CTRI, the participants will be recruited. All women in the inclusion criteria will be recruited in the study who fulfill required criteria and informed consent - All women will be graded based on VAS score and PABC score and USG findings as per MUSA’s criteria in USG - Assessment of the clinicopathological findings (age, adenomyotic lesion volumes, uterus volumes, subcutaneous fat thickness, CA125 level) and dysmenorrhea by odds ratios (ORs) and tabulation of the same - The information will be collected using a questionnaire and tabulated for further analysis. The total number of visits is limited to one and he information collected along with blood tests will be evaluated. -This study will determine the relationship of using CA125 as a biomarker in women who present with such symptoms and help in early detection and analysis of complications related to menorrhagia and dysmenorrhea. |