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CTRI Number  CTRI/2025/09/095475 [Registered on: 30/09/2025] Trial Registered Prospectively
Last Modified On: 29/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Impact of Bereavement care on Maternal satisfaction in cases of stillbirth  
Scientific Title of Study   Impact of Bereavement care on Maternal satisfaction in cases of stillbirth. 
Trial Acronym  GRACE 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manisha Kumar 
Designation  Professor Obs and Gynecology  
Affiliation  Lady Hardinge Medical College 
Address  Lady Hardinge Medical College

New Delhi
DELHI
110001
India 
Phone  9818014887  
Fax    
Email  manishaonly@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Bhavya Kejriwal 
Designation  Postgraduate student 
Affiliation  Lady Hardinge Medical College 
Address  Department of Obstetrics and Gynecology Lady Hardinge Medical College


DELHI
110001
India 
Phone  9818014887  
Fax    
Email  bhavya199ff@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Manisha Kumar 
Designation  Professor Obs and Gynecology  
Affiliation  Lady Hardinge Medical College 
Address  Lady Hardinge Medical College


DELHI
110001
India 
Phone  9818014887  
Fax    
Email  manishaonly@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Sarita Beri 
Address  Director, Lady Hardinge Medical College  
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 Manisha Kumar  Lady Hardinge Medical COllege  Dept of Obstetrics and Gynecology , LHMC
New Delhi
DELHI 
9818014887

manishaonly@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ethics committee for human research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O359||Maternal care for (suspected) fetal abnormality and damage, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  19.00 Day(s)
Age To  45.00 Day(s)
Gender  Female 
Details  Women delivering stillborn babies 
 
ExclusionCriteria 
Details  Women not willing to give consent to participate in the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Process measure:
Change in the mean utilization score of the bereavement care guide over 6 weeks.

Outcome measure:
Change in the mean satisfaction score of mothers delivering a stillborn over the period of study. 
end of one year 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcome
The distribution of causes according to ICD -10 PM classification 
End of one year 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   15/10/2025 
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)  Open to Recruitment 
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  

RESEARCH QUESTION: Will improving the practice of bereavement care increase maternal satisfaction after stillbirth in a tertiary care hospital?

 

Primary Objective

1. To assess the maternal satisfaction with the bereavement care provided at LHMC. 

 

Secondary Objective

1. To assess the improvement in the practice of bereavement care at LHMC.

2. To determine the cause of stillbirth according to International classification of diseases -10 Perinatal Mortality (ICD-10 PM) classification. 

 

MATERIAL AND METHODS

 

Inclusion Criteria

All women delivering a stillborn baby. 

 

Operational Definition

For inter country comparisons, World health organization (WHO) defines Stillbirth as the birth of a baby with no signs of life at birth at or after 28 weeks of gestation, or with a birth weight of 1000gms or more when the gestational age is not known.1

 

METHODOLOGY: All subjects fulfilling inclusion criteria will be recruited from the department of obstetrics and gynaecology of Lady Hardinge Medical College and Smt. Sucheta Kriplani Hospital from the time of admission to labour room till 24 hours after delivery. Informed consent will be taken from all mothers participating in the study. 

 

Planning the intervention: 

1.      Making a healthcare team consisting of staff nurses and doctors posted in the labour room.

2.      Assessing the team’s awareness about bereavement care using a pre-structured questionnaire for the healthcare team (appendix I). 

3.      Training of healthcare staff on the first 3 days of the month in the following manner: 

Conducting role play sessions to sensitise them about breaking bad news empathetically, responding to emotional distress and handling emotionally charged situations well. 

Making videos of mothers lived experiences and sharing it with our team to highlight the need of bereavement care. Confidentiality of patients will be ensured. 

This will be followed with an interactive discussion regarding respectful maternity care, psychological support, & lactation suppression.   

 

Implementation of change:

1. In the event of stillbirth, the health team will provide standard bereavement care.

2. A checklist of the essential components of care (bereavement care guide, appendix III) will be ticked according to the care provided and each component will get one point. 

3. Total score will be given for each bereavement counselling session, and two weekly assessments of scores will be done.

4. Fish bone analysis of the possible barriers in implementation will be done.

5. PDSA cycles will be carried out.

6. Change in mean utilization score from beginning to the end of the month will be the process measure.

 

Assessment of outcome: 

1. After 24 hours of stillbirth, “Maternity bereavement experience measure (MBEM)” questionnaire will be filled by the mothers experiencing stillbirth

2. The change in mean satisfaction score from beginning to the end of the study will be the outcome measure. 

 

“STANDARD BEREAVEMENT CARE” BUNDLE 7 : 

Bereavement care will be given in a bereavement room, identified within the labour room complex. 

1. Communication: Healthcare team will be encouraged to follow the SPIKES protocol while breaking the bad news to affected couples (setting, perception, invitation, knowledge, empathy, summary) 

2. Respectful maternity care is to be ensured (dignity, freedom from harm, informed consent, refusal and confidentiality) 

3. Making memories to remember the baby by means of creating handprints & footprints, holding the baby and taking photos.

4. Referral to the department of psychiatry, LHMC as and when mothers feel ready to talk about their grief.

5. Educating mothers about milk let down and milk donation and also giving them appropriate medications to prevent milk production. 

6. Identification of the cause of stillbirth according to the ICD-10 PM classification and appropriate follow up will be done. 

 

A “Bereavement Care Guide” with checklist will be placed in the bereavement rooms to monitor the implementation of standard bereavement care. It will help identify which components are being followed, highlight any gaps, explore the underlying causes, and guide targeted interventions in the subsequent Plan, do, study , act (PDSA) cycles.

 

 

 

 
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