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CTRI Number  CTRI/2021/03/032159 [Registered on: 19/03/2021] Trial Registered Prospectively
Last Modified On: 18/03/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Mental health of pregnant women during the covid 19 pandemic 
Scientific Title of Study   Mental health of pregnant women during covid 19 pandemic 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr S R Mudanur 
Designation  Head of Department 
Affiliation  Shri BM Patil Medical College 
Address  OBG Department Shri BM Patil Medical College and Research Center Solapur Rd, Bangaramma Sajjan Campus
OBG Department Shri BM Patil Medical College and Research Center Solapur Rd, Bangaramma Sajjan Campus
Bijapur
KARNATAKA
586103
India 
Phone    
Fax    
Email  drmudanurs@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr S R Mudanur 
Designation  Head of Department 
Affiliation  Shri BM Patil Medical College 
Address  OBG Department Shri BM Patil Medical College and Research Center Solapur Rd, Bangaramma Sajjan Campus
OBG Department Shri BM Patil Medical College and Research Center Solapur Rd, Bangaramma Sajjan Campus
Bijapur
KARNATAKA
586103
India 
Phone    
Fax    
Email  drmudanurs@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr S R Mudanur 
Designation  Head of Department 
Affiliation  Shri BM Patil Medical College 
Address  OBG Department Shri BM Patil Medical College and Research Center Solapur Rd, Bangaramma Sajjan Campus
OBG Department Shri BM Patil Medical College and Research Center Solapur Rd, Bangaramma Sajjan Campus
Bijapur
KARNATAKA
586103
India 
Phone    
Fax    
Email  drmudanurs@gmail.com  
 
Source of Monetary or Material Support  
Shri BM Patil Medical College and Research Center 
 
Primary Sponsor  
Name  Dr S R Mudanur 
Address  Bangaramma Sajjan Campus, Vijayapura, Karnataka 586103 
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 Sindhu Manne  Shri BM Patil Medical College and Research Center  OBG Department Shri BM Patil Medical College and Research Center Solapur Rd, Bangaramma Sajjan Campus
Bijapur
KARNATAKA 		 9553114488

drsindhumanne@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Shri BM Patil Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F59||Unspecified behavioral syndromes associated with physiological disturbances and physical factors,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  All pregnant women attending OPD for ANC checkup within private sector/govt setting in Vijayapura 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Socio-demographic scale
Depression Anxiety stress scale
IES-R25 		 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
N/A  N/A 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   01/04/2021 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
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 - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  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 - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drsindhumanne@gmail.com].

  6. For how long will this data be available start date provided 01-04-2021 and end date provided 31-12-2040?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Little is known about the changes in levels of psychological impact, stress, anxiety and depression during this pandemic in pregnant women. This is an attempt to know the above objective factors.  
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