FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/02/063200 [Registered on: 27/02/2024] Trial Registered Prospectively
Last Modified On: 06/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A study to see the effect of Enhanced recovery after surgery (ERAS) in patients undergoing Lower Segment Cesarian Section  
Scientific Title of Study   A two arm, single centre, prospective, randomized, interventional study to evaluate the effect of ERAS pathway Vs traditional methods in patients undergoing Lower Segment Cesarian Section (LSCS). 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kamalapriya Thiyagarajan 
Designation  Consultant Gynaecologist & Obstetrics  
Affiliation  Bhaktivedanta Hospital and Research Institute 
Address  Ground Floor, OPD No 1, Gynaecology Department

Thane
MAHARASHTRA
401107
India 
Phone  8879614447  
Fax    
Email  drkamalapriyat@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kamalapriya Thiyagarajan 
Designation  Consultant Gynaecologist & Obstetrics  
Affiliation  Bhaktivedanta Hospital and Research Institute 
Address  Ground Floor, OPD No 1, Gynaecology Department

Thane
MAHARASHTRA
401107
India 
Phone  8879614447  
Fax    
Email  drkamalapriyat@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kamalapriya Thiyagarajan 
Designation  Consultant Gynaecologist & Obstetrics  
Affiliation  Bhaktivedanta Hospital and Research Institute 
Address  Ground Floor, OPD No 1, Gynaecology Department

Thane
MAHARASHTRA
401107
India 
Phone  8879614447  
Fax    
Email  drkamalapriyat@gmail.com  
 
Source of Monetary or Material Support  
Bhaktivedanat Hospital and Research Institute, Mira Road, Thane, Maharashtra 
 
Primary Sponsor  
Name  Bhaktivedanta Hospital and Research Institute 
Address  Bhaktivedanta Swami Marg, Sector 6, Sector 1, Srishti Complex, Mira Road East, Mira Bhayandar, Thane, Maharashtra 401107 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kamalapriya Thiyagarajan   Bhaktivedanta Hospital and Research Institute  Dwing,4th Floor,Maternity ward, Bhaktivedanta Swami Marg, Sector 6, Sector 1, Srishti Complex, Mira Road East, Thane, Maharashtra 401107
Thane
MAHARASHTRA 
8879614447

drkamalapriyat@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bhaktivedanta Hospital Ethics Committee for Biomedical and Health Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O759||Complication of labor and delivery, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ERAS Pathway  The intervention includes ERAS pathway procedures which consists of mainly two components i.e., Education and fasting guidelines. A. Education: ï‚§ Dedicated preoperative counselling. B. Fasting Guidelines: ï‚§ May ingest light meal up to 6 hours before the procedure; may drink clear liquids up to 2 hours before procedure; fasting 2 hours before procedure (expect indicated preoperative medications) ï‚§ Day of surgery: Commercially available carbohydrate loading drink (to be completed at 2 hours before planned procedure start time) ï‚§ Eliminate anal mechanical bowel prep.  
Comparator Agent  Nil  Nil 
Intervention  Standard of care  2. Traditional method includes “fasting from midnight” which includes no food before 12 hours and no liquid intake before 6 hours perioperatively. 3. The recovery will be assessed by using the recovery based on obstetric-specific QoR 11 questionnaire in the timepoint of 12 hours ,24 hours postoperatively and at the timepoint of discharge. 4. The pain will be evaluated by using Visual Analog Scale (VAS Scale) on the day of surgery, 12 hours and 24 hours postoperatively and at the timepoint of discharge.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. All pregnant patients with gestational age ≥ 34 weeks
2. Patients under ASA grade I-II
3. Patients scheduled for elective cesarean section surgery.
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Dates of Birth or day of the Week 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. To check the efficacy of predefined ERAS protocol for better management of elective cesarean section patients.  At the timepoint of surgery, 24 hours post surgery, discharge 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the changes in the OBS QOL score in both the group , to compare the changes in VAS score in both the groups  24 hours post surgery, discharge 
 
Target Sample Size   Total Sample Size="94"
Sample Size from India="94" 
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)   18/03/2024 
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)
Modification(s)  
Not Applicable 
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
Modification(s)  

1. Current guidelines of Enhanced Recovery After Surgery (ERAS) recommend food and liquid intake perioperatively  6 hours and 2 hours respectively, for caesarean section to prevent complications.  ERAS accelerates patient recovery by standardizing perioperative care, including preoperative counselling and early mobilization. A study in India found that ERAS improved breastfeeding initiation, with 50.5% starting within the first hour and 34.7% within 2 to 4 hours postoperatively, compared to traditional care. ERAS also led to earlier ambulation, catheter removal, and reduced analgesic requirement, resulting in higher Quality of Recovery (QoR) scores at 24 hours postoperative. Despite the significant body of evidence indicating that ERAS protocols lead to improved outcomes, they challenge traditional surgical doctrine, and as a result their implementation has been slow. Therefore this study is being conducted with an objective to implement predefined ERAS protocol for better management of elective cesarean section patients, to compare quality of recovery based on obstetric-specific QoR 11 questionnaire. between patients undergoing ERAS and traditional protocol for elective LSCS, To compare the intensity of pain using Visual Analog Scale (VAS) score, Comparison of total duration of hospitalization between ERAS and traditional protocols, To evaluate the requirement of analgesics within 24 hours between both groups, To evaluate the duration in which the mobilization was initiated post operatively between both group.

2. All pregnant patients with gestational age ≥ 34 weeks, Patients under ASA grade I-II, Patients scheduled for elective cesarean section surgery will be included in the study. However, the patients with preexisting cardiac disease, extreme preterm labor < 34 weeks, diabetes, autoimmune disorder, severe and uncontrolled hypertension. , severe uncontrolled hypo/hyperthyroidism. patients with antepartum hemorrhage i.e., abruption placenta and placenta previa will be excluded from the study

3. This study is two arm in which the patients will be randomized based on computer based randomization technique

4. The patients who are randomized in Arm 1 (Control group) will follow the traditional method i.e.  “fasting from midnight” which includes no food before 12 hours and no liquid intake before 6 hours perioperatively.

5. The patients who are randomized in Arm 2 (Interventional group) will follow ERAS pathway procedure which includes the following

A. Preoperative procedures a day before the surgery.

a.     Education:

§  Dedicated preoperative counselling.

§  Counselling for enhanced protocol which will include details of ERAS program: its goals and benefits, spinal anaesthesia, benefits of early skin to skin contact and breast feeding.

B.  On the day of surgery:

§  Fasting for solid 6 h prior to surgery

§  Clear liquid will be allowed till 2 h before surgery.

§  25 g of glucose dissolved in 200 ml of water 2 h before surgery

C. Post surgery:

A.    Resumption of oral intake

§  Chewing gum/Lozenges and sips of water at 2h.

§  Clear fluid/juices at 4 h. Semisolid at 8 h after surgery.

B.    Mobilization

§  Early mobilization within 6 h of surgery.

The patients enrolled in both the groups will be assessed based on following questionnaire:

A.    The recovery will be assessed by using the recovery based on obstetric-specific QoR 11 questionnaire in the timepoint of 12 hours ,24 hours postoperatively and at the timepoint of discharge.

B.    The pain will be evaluated by using Visual Analog Scale (VAS Scale) on the day of surgery, 12 hours and 24 hours postoperatively and at the timepoint of discharge.

C.    At the timepoint of discharge (Day n): The patient feeding, mobilization patterns and QOL will be captured by using “Patient Questionnaire” which is validated and approved by EC

6. The data parameters includes the above mentioned questionnaires as well as , total hours within which attempt for mobilization was performed, total hours within which breast feeding was initiated,requirement of analgesics within 24 hours, total hours within which the catheter was removed post operatively, number of days of hospitalization, duration in which the bowel movement is back to normal, need for readmission of the patient (Yes/No) will be recorded

 

 

 

 

 
Close