| CTRI Number |
CTRI/2023/05/052786 [Registered on: 17/05/2023] Trial Registered Prospectively |
| Last Modified On: |
16/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Hyteroscopy in abnormal uterine bleeding pateints |
|
Scientific Title of Study
|
study of hysteroscopic evaluation in patent with AUB and its correlation with histopathology |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jyoti Ahlawat |
| Designation |
P G student |
| Affiliation |
Varunarjun medical college and rohilkhand hospital |
| Address |
Department of Obstetrics and Gynaecology Varun Arjun Medical College and Rohilkhand Hospital banthara shahjahanpur
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
8351985733 |
| Fax |
|
| Email |
jyotiahlawat0895@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K G Paul |
| Designation |
Professor |
| Affiliation |
Varunarjun Medical college and rohilkhand hospital |
| Address |
Department of Obstetrics and Gynaecology Varun Arjun Medical College and Rohilkhand Hospital banthara shahjahanpur
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
8178751027 |
| Fax |
|
| Email |
obgyvamc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyoti Ahlawat |
| Designation |
P G student |
| Affiliation |
Varunarjun Medical college and rohilkhand hospital |
| Address |
Department of Obstetrics and Gynaecology Varun Arjun Medical College and Rohilkhand Hospital banthara shahjahanpur
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
8351985733 |
| Fax |
|
| Email |
jyotiahlawat0895@gmail.com |
|
|
Source of Monetary or Material Support
|
| Varun Arjun Medical College and Rohilkhand Hospital banthara shahjahanpur Utter Pradesh |
|
|
Primary Sponsor
|
| Name |
Dr Jyoti Ahlawat |
| Address |
Varun Arjun Medical College and Rohilkhand Hospital Banthara Shahjahanpur |
| 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 |
| Jyoti ahlawat |
Varun arjun medical college and rohilkhand hospital |
obstetrics and gyanecology department room no 188
Shahjahanpur
UTTAR PRADESH |
8351985733
jyotiahlawat0895@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee vamc |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N719||Inflammatory disease of uterus, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1. Intermenstrual heavy bleeding (Menometrorrhagia),
2. Frequent cycles (Polymenorrhea), Infrequent menstrual bleeding (Oligomenorrhea).
3. Frequent and heavy menstrual bleeding (Polymenorrhagia),
4. Fibroid uterus
5. Uterovaginal congenital anomaly
|
|
| ExclusionCriteria |
| Details |
1. IUCD (Intrauterine contraceptive devices),
2. Hormone producing Ovarian tumours in USG,
3. Endocrine disorders like hyperthyroidism- or hypothyroidism,
4. Cervical malignancy
5. on medications like steroids, neuroleptics and anticoagulants, |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| to assess different causes of abnormal uterine bleeding |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to correlate hysteroscopic findings with histopathological results |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
25/06/2023 |
| 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="2"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a prospective observational study conducted on 150 patients attended the Varun
Arjun medical college and Rohilkhand to assess the role of diagnostic hysteroscopy and
histopathology in evaluation of abnormal uterine bleeding. The study was approved by the
Ethics Board and an informed written consent was taken from each participant in the study.
Careful history was taken including nature and severity of vaginal bleeding and symptoms
suggesting possible significant pathology. Physical examination (both general and local pelvic)
was performed. |