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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  
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 
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  
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 
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 
Details   
 
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.
 
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