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CTRI Number  CTRI/2024/05/067002 [Registered on: 08/05/2024] Trial Registered Prospectively
Last Modified On: 28/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Diagnostic 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To see if use of methylene blue in hysteroscopy better than conventional hysteroscopy in detecting endometrial abnormalities in the evaluation of heavy menstrual bleeding 
Scientific Title of Study   Efficacy of chromo-hysteroscopy vs conventional hysteroscopy in detection of endometrial pathology in abnormal uterine bleeding 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Megha Neelesh Karnik 
Designation  Assistant Professor 
Affiliation  Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research (DU) 
Address  Department of Obstetrics and Gynaecology, Ground floor, Acharya Vinoba Bhave Rural Hospital, Opp Jawaharlal Nehru Medical college, Sawangi (Meghe)

Wardha
MAHARASHTRA
442004
India 
Phone  9405605514  
Fax    
Email  mnkdr.karnik@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Megha Neelesh Karnik 
Designation  Assistant Professor 
Affiliation  Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research (DU) 
Address  Department of Obstetrics and Gynaecology, Ground floor, Acharya Vinoba Bhave Rural Hospital, Opp Jawaharlal Nehru Medical college, Sawangi (Meghe)

Wardha
MAHARASHTRA
442004
India 
Phone  9405605514  
Fax    
Email  mnkdr.karnik@gmail.com  
 
Details of Contact Person
Public Query  
Name  Neema Acharya 
Designation  Professor 
Affiliation  Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research 
Address  Department of Obstetrics and Gynaecology, Ground floor, Acharya Vinoba Bhave Rural Hospital, Opp Jawaharlal Nehru Medical college, Sawangi (Meghe)

Wardha
MAHARASHTRA
442004
India 
Phone  9326692511  
Fax    
Email  neemasacharya@gmail.com  
 
Source of Monetary or Material Support  
Acharya Vinoba Bhavr Rural Hospital & Jawaharlal Nehru Medical College, Sawangi (M), Wardha 
 
Primary Sponsor  
Name  Datta Meghe Institute of Higher Education and Research 
Address  Sawangi (Meghe), Wardha, Maharashtra 442004 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Megha Karnik  Acharya Vinoba Bhave Rural Hospital, sawangi  department of obstetrics and gynaecology, ground floor, near obgy opd area 11, AVBRH building,
Wardha
MAHARASHTRA 		 9405605514

mnkdr.karnik@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Institute of Higher Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  chromo hysteroscopy  4% methylene blue dye shall be used to stain the endometrial cavity after standard hysteroscopy and stained areas shall be subjected to biopsy 
Intervention  standard Hysteroscopy  standard hysteroscopy with 4mm Hysteroscope shall be used to obtained biopsy of the endometrium 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Female 
Details  1.age above 18 years
2.consenting
3.vitally stable
4.no gross findings on systemic and lab examination
5.fit for anesthesia.
 
 
ExclusionCriteria 
Details  1.minor
2.not consenting
3.patients with gross abnormality on clinical examination or radiological investigations
4.diagnosed case of Ca endometrium/ cervix. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
to compare the efficacy of chromohysteroscopy with conventinal hysteroscopy in detecting endometrial abnormalities in cases of AUB  at the first surgical sitting 
 
Secondary Outcome  
Outcome  TimePoints 
1.To classify the causes of Abnormal Uterine Bleeding based on hysteroscopy & histopathological findings of the endometrial samples retrieved
2.To correlate the hysteroscopic finding with the histopathological findings of the endometrial samples retrieved.
 		 at the end of 6 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   15/05/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - NO
Brief Summary  
  1.  abnormal uterine bleeding affects 5-35% women visiting the gynaecology outpatients department in hospitals and affects the daily life of the woman.
  2. endometrial sampling is required to reach the final diagnosis. Traditionally, AUB has been investigated with blind conventional procedures like D and C, fractional endometrial biopsy etc., but now, diagnostic hysteroscopy with hysteroscopic guided biopsy has become the gold standard diagnostic tool for evaluation of AUB. Although hysteroscopy facilitates adequate visualization of the uterine cavity and detection of intracavitary lesions, a normal appearance of endometrium in conventional diagnostic hysteroscopy does not ensure a normal histology.
  3. Endometrial pathology in these normal looking areas may be detected by chromo hysteroscopy. Chromoendoscopy with iodine has been widely used in gastrointestinal imaging to identify mucosal abnormalities by enhancing tissue characterization and differentiation. 
  4. Based on this technique, Methylene blue can be applied to the endometrium during conventional hysteroscopy to detect endometrial pathology that may not be seen by the naked eye during hysteroscopy. This led to the existence of the technique of chromo hysteroscopy. Chromo hysteroscopy, may help to decrease the subjective error and increase the sensitivity as compared to simple diagnostic hysteroscopy, and thus, is being studied for diagnosing AUB in this study.
  5. Diagnostic hysteroscopy would be performed using a 4.2mm hysteroscope in OT under anesthesia. The uterine cavity would be visualized and any abnormal area would be noted. For chromo hysterography, 10ml of 5% Methylene blue dye would be instilled through the water inlet channel.  The endometrial staining would be classified into two types - diffuse light blue staining and focal dark blue staining. Endometrial biopsies would be taken from the dark and diffusely stained areas and the abnormal and normal areas visualized on conventional hysteroscopy.
  6. At the end of examination, dilatation & curettage would be done. The obtained samples would be subjected to histopathological examination. The histopathology report would be compared between the samples retrieved by conventional hysteroscopy and chromo hysteroscopy.
  7. the aim is to evaluate and compare the efficacy of chromo hysteroscopy with conventional hysteroscopy in detecting endometrial pathology in cases of AUB
 
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