| CTRI Number | CTRI/2023/03/050523 [Registered on: 09/03/2023] Trial Registered Prospectively | 
    | Last Modified On: | 09/03/2023 | 
	
    | Post Graduate Thesis | Yes | 
    | Type of Trial | Observational | 
    | Type of Study | Cohort Study | 
    | Study Design | Other | 
    | Public Title of Study | Abnormal Uterine Bleeding and the Histopathological spectrum : An observational study | 
    | Scientific Title of Study | Correlation between the Clinicopathological Spectrum of Abnormal uterine
bleeding and Different methods of endometrial sampling in a Tertiary care unit | 
    | Trial Acronym | AUB | 
    | Secondary IDs if Any | 
    
        | Secondary ID | Identifier |  
            | NIL | NIL |  | 
    | Details of Principal Investigator or overall Trial Coordinator (multi-center study) | 
        
            | Name | YOGESWARI |  
            | Designation | JUNIOR RESIDENT |  
            | Affiliation | KMC MANIPAL |  
            | Address | NIH -A BLOCK, KASTURBA MEDICAL COLLEGE, MAHE MANIPAL 
 Udupi
 KARNATAKA
 576104
 India
 |  
            | Phone | 9789675787 |  
            | Fax |  |  
            | Email | yogi98.sf@gmail.com |  | 
    | Details of Contact Person Scientific Query
 | 
        
            | Name | REKHA |  
            | Designation | ASSOCIATE PROFESSOR |  
            | Affiliation | KMC MANIPAL |  
            | Address | KASTURBA MEDICAL COLLEGE, MAHE MANIPAL 
 
 KARNATAKA
 576104
 India
 |  
            | Phone | 9986143120 |  
            | Fax |  |  
            | Email | rex2000@rediffmail.com |  | 
    | Details of Contact Person Public Query
 | 
        
            | Name | REKHA |  
            | Designation | ASSOCIATE PROFESSOR |  
            | Affiliation | KMC MANIPAL |  
            | Address | KASTURBA MEDICAL COLLEGE, MAHE MANIPAL 
 
 KARNATAKA
 576104
 India
 |  
            | Phone | 9986143120 |  
            | Fax |  |  
            | Email | rex2000@rediffmail.com |  | 
    | Source of Monetary or Material Support | 
    
            
            | Kasturba Medical College, Manipal. |  | 
    | Primary Sponsor | 
        
            | Name | self  YogeswariS |  
            | Address | Door no.1, JJ nagar , Madurai |  
            | 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 |  
        | Yogeswari | KMC manipal | Department of OBG , Kasturba medical college , manipal Udupi
 KARNATAKA
 | 9789675787 
 yogi98.sf@gmail.com
 |  | 
    | Details of Ethics Committee | 
    
           | No of Ethics Committees= 1 |  
                | Name of Committee | Approval Status |  
                | IEC student research MAHE KMC | 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 |  
    | Comparator Agent | nil | nil |  | 
    | Inclusion Criteria | 
            
                | Age From | 19.00 Year(s) |  
                | Age To | 70.00 Year(s) |  
                | Gender | Female |  
                | Details | All Women between age 19-70 Presenting to gynecology opd with complaints of Abnormal uterine bleeding
 |  | 
    | ExclusionCriteria |  | 
    | Method of Generating Random Sequence |  | 
    | Method of Concealment |  | 
    | Blinding/Masking |  | 
    | Primary Outcome | 
             
                | Outcome | TimePoints |  
                | To study the various Clinico- pathological Pattern in women with Abnormal Uterine Bleeding from different age groups
 | 2 weeks and 4 weeks |  | 
    | Secondary Outcome | 
             
                | Outcome | TimePoints |  
                | a. To compare the different diagnostic modalities used to obtain 
 Endometrial tissue Sampling.
 b. To analyze their positive and negative predictive values.
 | 2 weeks and 4 weeks |  | 
    | Target Sample Size | Total Sample Size="405" Sample Size from India="405"
 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 | 
    | Date of First Enrollment (India) | 13/03/2023 | 
	
| 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="1"
 Days="1"
 | 
    | Recruitment Status of Trial (Global) | Not Yet Recruiting | 
    | Recruitment Status of Trial (India) | Not Yet Recruiting | 
    | Publication Details |  | 
	
| Individual Participant Data (IPD) Sharing Statement | 
    
        Will individual participant data (IPD) be shared publicly (including data dictionaries)?  Response  - NO          | 
    | Brief Summary | Abnormal Uterine Bleeding is the most common presenting complaint among women of all age group visiting Gynecology . One third of patients attending gynaecology OPD present with complaints of abnormal uterine bleeding(1). AUB is charecterised by any deviation form the normal pattern/frequency, duration and severity of normal menstrual flow.Recently, the International Federation of Gynecology and Obstetrics working group on menstrual disorder has developed a classification system (PALM-COEIN) for causes of the AUB in non-gravid women of reproductive age. There are nine main categories, which are arranged according to the acronym PALM-COEIN: Polyp; adenomyosis; leiomyoma; malignancy and hyperplasia; coagulopathy; ovulatory dysfunction; endometritis; iatrogenic; and not yet classified [2].Although radiological examination is the first mode of diagnosis in most cases, Histopathological evaluation is the most relied method for diagnosis and planning further management.The various mode of obtaining Endometrial samples like – D and C, Endocell, Mannual vaccum aspiration have made the diagnosis of AUB much easier. Endometrial biopsy and curettage are chief sampling methods [3].The cause of AUB may widely vary from a simple polyp to malignancy. AUB in perimenopausal and postmenopausal patients warrants thorough evaluation because AUB is the only clinical symptom of endometrial carcinoma in most patients. |