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CTRI Number  CTRI/2025/05/086538 [Registered on: 07/05/2025] Trial Registered Prospectively
Last Modified On: 23/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes
Behavioral
Other (Specify) [Educational pamphlets]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study on impact of different fasting durations before Caesarean section on mother’s health 
Scientific Title of Study   Comparison of the actual fasting duration for liquids/clear fluids, perioperative haemodynamic changes and maternal satisfaction in parturients undergoing caesarean section after introducing educational pamphlets and checklists: An observational quality improvement study 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Moksha Kanwar Sisodiya  
Designation  Resident Doctor 
Affiliation  Dr. SNMC JODHPUR  
Address  E, 329-330, Rameshwar Nagar, Basni, First Phase, Jodhpur, Rajasthan

Jodhpur
RAJASTHAN
342005
India 
Phone  8003543376  
Fax    
Email  sisodiyamoksha26@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sarita Janweja 
Designation  Senior Professor  
Affiliation  Dr. SNMC JODHPUR  
Address  C, 201 Saraswati Nagar, Basni, First Phase, Jodhpur, Rajasthan

Jodhpur
RAJASTHAN
342005
India 
Phone  9829116420  
Fax    
Email  sarita.janweja@gmail.com  
 
Details of Contact Person
Public Query  
Name  Moksha Kanwar Sisodiya  
Designation  Resident Doctor  
Affiliation  Dr. SNMC JODHPUR  
Address  E, 329-330, Rameshwar Nagar, Basni, First Phase, Jodhpur, Rajasthan

Jodhpur
RAJASTHAN
342005
India 
Phone  8003543376  
Fax    
Email  sisodiyamoksha26@gmail.com  
 
Source of Monetary or Material Support  
Dr SNMC Jodhpur Rajasthan India 32003 
 
Primary Sponsor  
Name  Dr S N Medical college Jodhpur  
Address  Residency road, sector D, Shastri Nagar, Jodhpur, Rajasthan, India 324003 
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 Moksha Kanwar Sisodiya  Dr S N Medical college Jodhpur  Department of Anaesthesiology, Near central laboratory, Sector, D, Shastri Nagar, Jodhpur 342003
Jodhpur
RAJASTHAN 		 8003543376

sisodiyamoksha26@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr. SNMC, Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O899||Complication of anesthesia duringthe puerperium, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Blanket fasting orders  This group of individuals will receive blanket fasting order by the surgeon according to institutional protocol 
Intervention  Educational pamphlets and Carbohydrate drink  Educational pamphlets will educate the patients regarding the actual fasting guidelines and when to eat and will improve the overall satisfaction rate by decreasing anxiety and carbohydrate drink 200 mL 2 hours prior to surgery will improve peri operative haemodynamics and improved maternal satisfaction and reduced incidence of postoperative nausea and vomiting 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  (1) full-term childbirth (more than 37 weeks of pregnancy); (2) meeting the indications of cesarean section operation according to the criterion made by Obstetrics group, Obstetrics and Gynecology, (3) receiving the spinal anaesthesia for elective LSCS. 
 
ExclusionCriteria 
Details  (1) women combined with serious surgical diseases; (2) placenta accreta and placenta adhesion; (3) twins and multiple births; (4) esophageal hiatal hernia and gastro esophageal reflux disease history; (5) fetal distress; (6) anemia, pregnancy-induced hypertension, abnormal glucose metabolism, and others with pregnancy complications, and (7) using gastrointestinal stimulation drugs, antacids, anticholinergic drugs before surgery, (8) mental illness, serious heart, lung, liver, kidney, blood system disease. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the impact of optimization of pre operative fasting duration for liquids/clear fluids by introduction of educational pamphlets and checklists on perioperative haemodynamics and maternal satisfaction score using LIKERT scale in parturients undergoing elective LSCS.  Before Subarachnoid block, 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, 6 minutes, 7 minutes, 8 minutes, 9 minutes, 10 minutes, 15 minutes,20 minutes, 25 minutes, 30 minutes, 35 minutes, 40 minutes, 45 minutes, 50 minutes, 55 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, 120 minutes, 135 minutes, 150 minutes, 165 minutes, 180 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate the actual fasting duration for solids for parturients undergoing elective LSCS.
2. To compare the impact of decreasing fasting duration & intra operative vasopressor requirement.
3. To compare the incidence of post operative nausea & vomiting.
4. To compare the occurrence of hypoglycemia of mother & neonate.
5. To evaluate the factors responsible for noncompliance of the recommended fasting guidelines.
 		 Before Subarachnoid block, 1 minutes, 2 minutes, 3 minutes, 4 minutes, 5 minutes, 6 minutes, 7 minutes, 8 minutes, 9 minutes, 10 minutes, 15 minutes,20 minutes, 25 minutes, 30 minutes, 35 minutes, 40 minutes, 45 minutes, 50 minutes, 55 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, 120 minutes, 135 minutes, 150 minutes, 165 minutes, 180 minutes 
 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   08/05/2025 
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="0"
Months="9"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sisodyamoksha26@gmail.com].

  6. For how long will this data be available start date provided 02-01-2025 and end date provided 02-01-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Fasting duration before the surgery is a very debatable topic in India as many surgeons, nursing staff and patients follow blanket fasting orders which contradicts the ASA and ISA fasting guidelines and which leads to perioperative harm to the patients in many ways, such as intra operative hemodynamic changes, changes in the rbs values, decreased overall satisfaction score of the patients, dehydration. hence through this study we want to educate everyone including the patients regarding proper and correct guidelines and plan to work on their compliance or non compliance. 
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