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CTRI Number  CTRI/2023/08/056381 [Registered on: 10/08/2023] Trial Registered Prospectively
Last Modified On: 07/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study done to assess the perception of labour pain relief management among mothers who undergo delivery at our institute. 
Scientific Title of Study   Perception of postnatal women on intrapartum analgesia in a tertiary care hospital - a Quantitative analysis. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shilpa Dan D 
Designation  Post Graduate Registrar 
Affiliation  Christian Medical College 
Address  Department of Anaesthesiology, Christian Medical College, Vellore.

Vellore
TAMIL NADU
632004
India 
Phone  9443518928  
Fax    
Email  shilpadan610@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Smitha Elizabeth George 
Designation  PROFESSOR 
Affiliation  Christian Medical College 
Address  Department of Anaesthesiology, Christian Medical College, Vellore.

Vellore
TAMIL NADU
632004
India 
Phone  9655820582  
Fax    
Email  smitha.lizgeorge@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shilpa Dan D 
Designation  Post Graduate Registrar 
Affiliation  Christian Medical College 
Address  Department of Anaesthesiology, Christian Medical College, Vellore.

Vellore
TAMIL NADU
632004
India 
Phone  9443518928  
Fax    
Email  shilpadan610@gmail.com  
 
Source of Monetary or Material Support  
Fluid Research Grant, Christian Medical College, Vellore - 632004, Tamil Nadu, Indi. 
 
Primary Sponsor  
Name  Shilpa Dan D 
Address  Dr Shilpa Dan, Department of Anaesthesiology, Christian Medical College, Vellore 632004, Tamil Nadu, India. 
Type of Sponsor  Other [] 
 
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 Shilpa Dan D  Christian Medical College  Department of Anaesthesiology, Vellore.
Vellore
TAMIL NADU 
9443518928

shilpadan610@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, Christian Medical College, Vellore.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  All women who had delivered in our institution via normal vaginal delivery, instrumental delivery, emergency Caesarean section 
 
ExclusionCriteria 
Details  Women who are not willing to participate in the study
Women who have undergone elective Caesarean section
Women in the age group of less than 19 years or more than 40 years
Women who are unable to read and write on their own 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the perception of postnatal women on labour pain relief methods  24hrs to 48hrs 
 
Secondary Outcome  
Outcome  TimePoints 
Correlation between socio-demographic factors & the perception on labour pain relief methods & labour epidural will be assessed. The variables in the questionnaire include age, level of education of the women, income, occupation, previous experience on labour, previous knowledge of epidural analgesia.
To find out the various reasons for the refusal of labour epidural among our postnatal patients.
 
24hrs to 48hrs 
 
Target Sample Size   Total Sample Size="256"
Sample Size from India="256" 
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)   17/08/2023 
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="10"
Days="30" 
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  

Most of the women experience moderate to severe pain at the time of delivery. There are various labour pain relief methods available. This study will be done among postnatal women who will undergo delivery  in our institution. All postnatal women in the early postpartum period during their stay in hospital after delivery will be included in this study after getting approval from IRB. Written informed consent will be obtained by the principal investigator from the postnatal women after explaining the purpose and intention of the study. First, a set of structured questionnaire will be prepared. These questions will contain three sections. First section will include the demographic characteristics. Second section will contain a set of self-administered questionnaire to assess the perception of labour analgesia and the third section to assess the perception toward labour epidural analgesia. Answer types include Yes/ No, multiple choice questions. This questionnaire will be tested out on a sample population of the postnatal women. The questionnaire will be validated by obstetricians, anaesthesiologists and staff nurses working in the labour room. The validated questionnaire will be given to the participants after taking consent in their preferred language and they will be requested to complete them.  Investigators will also be available to clarify any doubts regarding the questions. The completed questionnaire will be collected, evaluated and analysed to assess the knowledge of the postnatal women about labour pain relief methods and the reasons for the refusal of labor epidural.

 
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