| CTRI Number |
CTRI/2021/12/038777 [Registered on: 21/12/2021] Trial Registered Prospectively |
| Last Modified On: |
20/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
To compare the efficacy of Transvaginal Ultrasonography and Office hysteroscopy in AUB patients
|
|
Scientific Title of Study
|
THE EFFICACY OF TRANSVAGINAL ULTRASONOGRAPHY AND OFFICE HYSTEROSCOPY IN EVALUATION OF ABNORMAL UTERINE BLEEDING(AUB) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SONA TEJASWI M R |
| Designation |
Resident |
| Affiliation |
BLDE(DU) Shri BM Patil Medical College Hospital and Research Center |
| Address |
Dept of OBG BLDE(DU) Shri BM Patil Medical College Hospital and Research Centre, Vijayapura , Karnataka. PIN 586103 Bijapur KARNATAKA 586103 India
Bijapur
KARNATAKA 586103
India
Bijapur
KARNATAKA
586103
India |
| Phone |
9618546097 |
| Fax |
|
| Email |
sonarupraj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S R Mudanur |
| Designation |
Professor and Head of the Department |
| Affiliation |
BLDE(DU) Shri BM Patil Medical College Hospital and Research Center |
| Address |
Dept of OBG BLDE(DU) Shri BM Patil Medical College Hospital and Research Center, Vijayapura , Karnataka. PIN 586103 Bijapur KARNATAKA 586103 India
Bijapur
KARNATAKA 586103
India
Bijapur
KARNATAKA
586103
India |
| Phone |
|
| Fax |
|
| Email |
drmudanurs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sona Tejaswi M R |
| Designation |
Resident |
| Affiliation |
BLDE(DU) Shri BM Patil Medical College Hospital and Research Center |
| Address |
Dept of OBG BLDE(DU) Shri BM Patil Medical College Hospital and Research Center, Vijayapura , Karnataka. PIN 586103 Bijapur KARNATAKA 586103 India
Bijapur
KARNATAKA
586103
India |
| Phone |
|
| Fax |
|
| Email |
sonarupraj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri BM Patil Medical College BLDE DU Vijayapura Karnataka 586103 |
|
|
Primary Sponsor
|
| Name |
Shri BM Patil Medical College |
| Address |
Blde Deemed To Be University Shri Bm Patil Medical College Hospital And Research Centre Blde (Deemed To Be University), Smt. Bagaramma Sajjan Campus, Dr B M Patil Road (Solapur Road) Vijayapura(Bijapur)-586103, Karnataka, India |
| 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 |
| DrM R Sona Tejaswi |
Shri Bm Patil Medical Colege |
Department of Obstetrics and Gynaecology Shri BM Patil Medical College BLDE (Deemed to be University), Smt. Bagaramma Sajjan Campus, Dr B M Patil Road (Solapur Road) Vi jayapura(Bijapur)-5861 03, Karnataka, INDIA Bijapur
KARNATAKA
Bijapur
KARNATAKA |
9618546097
sonarupraj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N719||Inflammatory disease of uterus, unspecified. Ayurveda Condition: not applicable, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
All womwn above 18yrs and with AUB are included in the study |
|
| ExclusionCriteria |
| Details |
Pregnacy
Pelvic inflammatory disease
Ongoing vaginal infections |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine sensitivity and specificity of TVS , Hysteroscopy |
1 to 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the causes of Abnorml Uterine bleeding |
1week to 1month |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
30/12/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nill |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is a comparison between office hysteroscopy and trans vaginal ultrasonography and correlate the findings with histopathology. |