| CTRI Number |
CTRI/2023/07/055196 [Registered on: 13/07/2023] Trial Registered Prospectively |
| Last Modified On: |
30/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
An observational study of Abnormal Uterine Bleeding |
|
Scientific Title of Study
|
Clinicopathological Study of Abnormal Uterine Bleeding in A Tertiary Hospital; An Observational Study. |
| 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 RADHIKA GOPAKUMAR |
| Designation |
Junior Resident |
| Affiliation |
KMC, Manipal |
| Address |
Department of Obstetrics and Gynecology,
KMC, Manipal,Udupi .
Udupi
KARNATAKA
576104
India |
| Phone |
9535398534 |
| Fax |
|
| Email |
rosethomasmedico123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHRIPAD HEBBAR |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
KMC, Manipal |
| Address |
Depatment of Obstetrics and Gynecology,
KMC, Manipal, Udupi.
Udupi
KARNATAKA
576104
India |
| Phone |
9611786463 |
| Fax |
|
| Email |
shripad.hebbar@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
DR SHRIPAD HEBBAR |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
KMC, Manipal |
| Address |
Department of Obstetrics and Gynecology,
KMC, Manipal,Udupi.
Udupi
KARNATAKA
576104
India |
| Phone |
9611786463 |
| Fax |
|
| Email |
shripad.hebbar@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal, Udupi District, Karnataka, 576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Hospital, Manipal |
| Address |
KMC, MADHAV NAGAR, MANIPAL, UDUPI DISTRICT, KARNATAKA, 576104 |
| Type of Sponsor |
Private medical college |
|
|
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 RADHIKA GOPAKUMAR |
Kasturba Medical College |
Department of Obstetrics and gynecology and Department of Pathology,
KMC, Manipal, Udupi, Karnataka, 576104
Udupi
KARNATAKA |
9535398534
rosethomasmedico123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N939||Abnormal uterine and vaginal bleeding, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients with age between 30-70 years with abnormal uterine bleeding.
2. Both parous and nulliparous women.
3. Patients not requiring emergency management.
4. Premenopausal with previously diagnosed leiomyoma and adenomyosis, polyp with ET > 12 mm.
5. Postmenopausal with previously diagnosed leiomyoma and adenomyosis with ET > 5 mm.
|
|
| ExclusionCriteria |
| Details |
1. Women with pregnancy related complications like threatened/incomplete/missed miscarriage and ectopic pregnancy, gestational trophoblastic diseases and haemostatic disorders were excluded from the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To study the histopathological pattern of endometrium in abnormal uterine bleeding(AUB)
2.To correlate the histopathological findings with demographic profile of the patient
3.To understand the relevance of endometrial samplings in the management of AUB. |
1 & a half years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study the histopathological pattern of endometrium in abnormal uterine bleeding(AUB)
2.To correlate the histopathological findings with demographic profile of the patient
3.To understand the relevance of endometrial samplings in the management of AUB. |
1 & a half years |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/07/2023 |
| Date of Study Completion (India) |
28/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
28/02/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This is an observational study which will conducted involving department of OBG and pathology in kasturba hospital , Manipal. Detailed demographic parameters of women in reproductive, perimenopausal and postmenopausal(30-70 years age) coming to OPD of OBG department will be taken. History, general physical examination, abdomen and pelvic examination and routine investigations will be observed on a specially made proforma and case selected. Imaging findings (Transabdominal, transvaginal ultrasound reports), type of enodmetrial evaluation(endocell/D&C/Hysteroscopy) , histological features as given by pathology department and treatment modality (medical/surgical) will be recorded. Demogrpahic profiling including menstrual pattern and risk factors will be mapped with histopathological changes. Treatment according to histological pattern will be analyzed. |