FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/07/055918 [Registered on: 31/07/2023] Trial Registered Prospectively
Last Modified On: 03/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Views of pregnant women who have delivered their babies towards quality of care given in a hospital in New Delhi 
Scientific Title of Study   A cross-sectional study on the perceptions of respectful maternity care among postnatal women at a tertiary care hospital in New Delhi 
Trial Acronym  RMC 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Irena Mandal 
Designation  Postgraduate Resident 
Affiliation  Maulana Azad Medical College, New Delhi 
Address  Room No. 359, Department of Community Medicine, 3rd Floor, Pathology Block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi
Flat No. B-906, 9th Floor, Kanak Durga CGHS Limited, Plot No. 26, Sector 12, Dwarka, New Delhi-110075
South West
DELHI
110002
India 
Phone  7042008254  
Fax    
Email  irenamandal5940@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  M. Meghachandra Singh 
Designation  Director Professor & Head of Department 
Affiliation  Maulana Azad Medical College, New Delhi 
Address  Room No. 359, Department of Community Medicine, 3rd Floor, Pathology Block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi

Central
DELHI
110002
India 
Phone  9818354458  
Fax    
Email  megharita1@gmail.com  
 
Details of Contact Person
Public Query  
Name  Irena Mandal 
Designation  Postgraduate Resident 
Affiliation  Maulana Azad Medical College, New Delhi 
Address  Room No. 359, Department of Community Medicine, 3rd Floor, Pathology Block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi
Flat No. 906, 9th Floor, Block B, Kanak Durga CGHS Ltd, Plot No. 26, Sector 12, Dwarka, New Delhi-110075
South West
DELHI
110002
India 
Phone  7042008254  
Fax    
Email  irenamandal5940@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad Medical College, Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi, Delhi 110002 
 
Primary Sponsor  
Name  Maulana Azad Medical College 
Address  Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi, Delhi 110002 
Type of Sponsor  Government 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 Irena Mandal  Lok Nayak Hospital, New Delhi  Postnatal ward, 2nd Floor, Department of Obstetrics and Gynaecology, Lok Nayak Hospital, Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi, Delhi 110002
Central
DELHI 		 7042008254

irenamandal5940@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, MAULANA AZAD MEDICAL COLLEGE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  INCLUSION CRITERIA:
Women who have delivered between 12-48 hours in LN Hospital, New Delhi at the time of data collection.
 
 
ExclusionCriteria 
Details  EXCLUSION CRITERIA:
1. Severely ill bedridden women who are not in a position to communicate.
2. Women under the age of 18 and single mothers 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Proportion of postnatal women who perceived disrespect in the following subscales of the modified Person-centered maternity care (PCMC) scale 22 viz; Dignity & Respect, Communication & Autonomy, Supportive Care, Privacy & confidentiality, Trust, Facility & environment, and Predictability and transparency of payment.  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
1. Distribution of primigravida & multigravida women attending institutional delivery.
2. Association of socio-economic and demographic variables with respectful maternity care. 		 1 year 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   01/08/2023 
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="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   In this study, the principal investigator will recruit postnatal patients from postnatal wards from Lok Nayak Hospital, New Delhi who fulfil the study criteria. On obtaining informed consent, the participants will be administered a questionnaire including the Person Centered Maternity scale (PCMC scale). From the responses collected we will ascertain the perceptions of respectful maternity care among postnatal women delivering in a tertiary care hospital in New Delhi. 
Close