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CTRI Number  CTRI/2026/04/107893 [Registered on: 08/04/2026] Trial Registered Prospectively
Last Modified On: 11/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   comparison of Uterine visualisation Findings with Tissue Test Results in Premenopausal and Postmenopausal Women with Abnormal Uterine Bleeding .  
Scientific Title of Study   Correlation of Hysteroscopic and Histopathological Findings in Premenopausal and Postmenopausal Women with Abnormal Uterine Bleeding .  
Trial Acronym  HYSTERO and HISTO AUB Study .  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Muskaan Singhal 
Designation  Junior Resident  
Affiliation  National institute of medical sciences and research 
Address  C-2/129 2nd floor janakpuri
National institute of medical sciences and research , delhi jaipur expressway , jaipur NH 11 C , pincode 303121
South West
DELHI
110058
India 
Phone  7217743943  
Fax    
Email  singhalmuss.3011@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Poonam Bhojwani  
Designation  Professor 
Affiliation  National institute of medical sciences and research 
Address  D 303 Basant Gokul Dam Society Siddharth Nagar Malviya Nagar Jaipur
National institute of medical sciences and research , delhi jaipur expressway , jaipur NH 11 C , pincode 303121
Jaipur
RAJASTHAN
302017
India 
Phone  9571875783  
Fax    
Email  poonambhojwani1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Poonam Bhojwani  
Designation  Professor 
Affiliation  National institute of medical sciences and research 
Address  D 303 Basant Gokul Dam Society Siddharth Nagar Malviya Nagar Jaipur
National institute of medical sciences and research , delhi jaipur expressway , jaipur NH 11 C , pincode 303121
Jaipur
RAJASTHAN
302017
India 
Phone  9571875783  
Fax    
Email  poonambhojwani1@gmail.com  
 
Source of Monetary or Material Support  
NIMS HOSPITAL, NATIONAL INSTITUTE OF MEDICAL SCIENCES AND RESEARCH, Delhi-Jaipur expressway, NH-11c, Chandwaji, Rajasthan-303121 
 
Primary Sponsor  
Name  Dr Muskaan Singhal 
Address  C2,129 Second floor , Janakpuri ,Delhi 110058 
Type of Sponsor  Other [SELF. ] 
 
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 Muskaan Singhal  DEPARTMENT OF OBSTETRICS AND GYNAECOLOGICAL  NIMS Hospital,Jaipur NH 11 C ,Delhi Jaipur Expressway , Rajasthan 303121
Jaipur
RAJASTHAN 
7217743943

singhalmuss.3011@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
National Institute of Medical Sciences and Research Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  35.00 Year(s)
Age To  75.00 Year(s)
Gender  Female 
Details  Women aged more than or equal to 35 years presenting with abnormal uterine bleeding.
Women who have undergone both hysteroscopy and endometrial sampling.
Premenopausal women with regular or irregular menstrual cycles experiencing AUB.
Postmenopausal women with cessation of menstruation for more than or equal to 12 months presenting
with vaginal bleeding.
Patients willing to provide written informed consent.
 
 
ExclusionCriteria 
Details  Pregnant or suspected pregnant women
Lactating women
Females using intrauterine contraceptive devices
Women undergone endometrial ablation or hysterectomy
Women on medication such as oral contraceptive pills,antipsychotics,anticoagulants.
Women with thyroid disorder,hyperprolactenima,systemic diseases like liver and renal disease .
Patients refusing consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
How accurately do hysteroscopic findings correlate with histopathological diagnosis or findings in
women with abnormal uterine bleeding and does this accuracy differ between premenopausal
and postmenopausal women?

 


18 months 
 
Secondary Outcome  
Outcome  TimePoints 
Correlation oc hysteroscopic & endomsterial boipsy results in premenopausal & postmenopausal women with abnormal uterine bleeding   18 months 
 
Target Sample Size   Total Sample Size="94"
Sample Size from India="94" 
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)   10/04/2026 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response (Others) -  The required data will be shared according to the thesis protocol

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Master chart

  6. For how long will this data be available start date provided 10-04-2026 and end date provided 31-03-2027?
    Response (Others) -  NIL

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL .
Brief Summary   Abnormal Uterine Bleeding (AUB) is defined as bleeding from the uterine corpus that is
abnormal in volume, regularity, or duration and has been present for the majority of the last
six months It represents one of the most common reasons for gynecologic consultations globally and has
significant implications for a woman’s physical, emotional, and social well-being
Traditionally, evaluation of AUB involves clinical history, physical examination, laboratory
investigations, imaging modalities like transvaginal ultrasound(TVS),and histopathological
assessment via endometrial sampling
However, these approaches often provide incomplete information, especially in cases where
pathologies are focal or subclinical.
The PALM-COEIN classification by FIGO standardizes AUB causes into structural (Polyps,
Adenomyosis, Leiomyoma, Malignancy) and non-structural (Coagulopathy, Ovulatory
dysfunction, Endometrial, Iatrogenic, Not yet classified) categories
While TVS is helpful for assessing uterine morphology, its sensitivity is limited in detecting
intrauterine abnormalities like adhesions, small polyps, or hyperplasia . Hysteroscopy has
revolutionized the diagnostic approach to AUB by allowing direct visualization of the
uterine cavity, making it possible to assess even minute lesions . It has become a
cornerstone in evaluating abnormal uterine bleeding, particularly when structural
abnormalities are suspected or when initial investigations are inconclusive
The integration of hysteroscopy into outpatient settings, coupled with advancements in optics
and instrumentation, has reduced complications, improved patient acceptability, and allowed
for real-time intervention . Studies have demonstrated hysteroscopy’s high sensitivity and
specificity, especially when combined with histological confirmation .
This study aims to highlight the role of diagnostic hysteroscopy as a superior alternative to
blind procedures like dilation and curettage (D&C), emphasizing its utility in identifying
causative pathology and guiding targeted therapy
This study will aim towards bridging the diagnostic gap in Abnormal uterine blreeding
evaluation by validating the role of hysteroscopy in real-world clinical settings This will
involve Correlating hysteroscopic findings with histopathology to assess sensitivity, specificity, and
predictive value .
While hysteroscopy is widely used in tertiary care centers, its adoption in primary or
secondary care is limited, often due to lack of awareness or perceived complexity .
Demonstrating its efficiency and cost-effectiveness could promote wider acceptance and
integration into primary sectors.

 
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