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CTRI Number  CTRI/2020/10/028652 [Registered on: 27/10/2020] Trial Registered Prospectively
Last Modified On: 26/10/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Early recovery after planned caesarean delivery 
Scientific Title of Study   Efficacy and feasibility of Enhanced Recovery After Surgery (ERAS) protocol on functional recovery in women undergoing elective caesarean delivery: A randomized clinical trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vidushi Kulshrestha 
Designation  Associate professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room No 3082-A, Third Floor, Teaching Block, Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, New Delhi

New Delhi
DELHI
110029
India 
Phone  9891910880  
Fax    
Email  drvidushi.kul@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Vidushi Kulshrestha 
Designation  Associate professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room No 3082-A, Third Floor, Teaching Block, Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, New Delhi


DELHI
110029
India 
Phone  9891910880  
Fax    
Email  drvidushi.kul@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Nisha 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room No 3076, Third Floor, Teaching Block, Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, New Delhi

New Delhi
DELHI
110029
India 
Phone  8606189624  
Fax    
Email  nisharao.gudiya@gmail.com  
 
Source of Monetary or Material Support  
AIIMS, New Delhi 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences New Delhi 
Address  Ansari Nagar East, New Delhi -110029 
Type of Sponsor  Research institution and hospital 
 
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 Vidushi Kulshrestha  AIIMS, New Delhi  Department of Obstetrics and Gynecology, AIIMS, Ansari Nagar East, New Delhi
New Delhi
DELHI 
9891910880

drvidushi.kul@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee for Postgraduate Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ERAS Protocol Implementation  Combination of Preoperative counseling, intraoperative optimization and postoperative care (including regional anesthesia, optimizing pain control, prophylactic anti-emetics, early nutrition, early mobilization, early catheter removal etc) 
Comparator Agent  Routine protocol  Routine preoperative, intraoperative and postoperative care as is the routine in the ward 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Women planned for elective caesarean delivery with no significant obstetric and medical complication 
 
ExclusionCriteria 
Details  - Patients with significant obstetric and medical complications
- Previous 2 or more LSCS or other abdominal surgeries or known case abdominal Koch’s
- Contraindications for neuraxial anesthesia
- Not willing to participate in the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Numerical rating scale(NRS)  At 6 hours, 12 hours, 24 hours, 26 hours and 48 hours after caesarean 
 
Secondary Outcome  
Outcome  TimePoints 
-Need for rescue analgesics
-Postoperative recovery
- Postoperative nausea, vomitting
- postoperative complication if any
-adherence to ERAS protocol
Protocol deviation rates and reasons
Time for patients readiness for discharge from Maternity unit
- Patient satisfaction on Likert scale
-Patient satisfaction with semi-structured questionnaire 
24 and 48 hours after caesarean 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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)   29/10/2020 
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="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This prospective randomized clinical trial is being planned to compare efficacy and feasibility of Enhanced Recovery after Surgery (ERAS) protocol implementation vs. routine perioperative care in women undergoing elective cesarean delivery. The primary objective is to compare pain control in terms of Numerical rating scale (NRS). As secondary outcome; postoperative recovery, need for rescue analgesics, adherence to ERAS protocols and factors leading to non-adherence, patient’s readiness for discharge from maternity unit with ERAS protocol vs. routine perioperative care, patient satisfaction on Likert scale; will also be noted. Postoperative recovery will be noted in terms of time taken by patients to achieve postoperative milestones such as tolerance to diet, resumption of bowel function, ambulation and postoperative complications if any.

The purpose of the present study is to evaluate the efficacy and feasibility of ERAS implementation in achieving functional recovery in women undergoing elective cesarean section in Indian scenario. 

Study has been approved by the Institute Ethics committee. Antenatal women booked in the Department of Obstetrics and Gynaecology at All India Institute of Medical Sciences, New Delhi and planned for elective caesarean delivery will be recruited according to the inclusion and exclusion criteria. After explaining the detailed plan and purpose study in their own language and giving a copy of Patient Information Sheet, informed written consent will be taken on a preformed consent form. Enrolled women will be randomized into two groups (70 patients in each group) according to computer generated randomization table. Patients in group 1 will be managed with ERAS protocol and patients in group 2 will be the control group managed with traditional protocol.
Patients will be operated by different surgeons, but all patients will be cared for in the same ward. 

ERAS protocol will involve three components:

Preoperative preparation with Education/Counseling, Preoperative oral intake, Prophylactic antibiotics, Aspiration prophylaxis.

Intraoperative Optimization with Standard anesthetic protocol, Skin cleansing, preventing hypothermia, Skin to skin care and delayed cord clamping, Intra-operative oxytocin, Prophylaxis for postoperative nausea and vomiting, Perioperative fluid and blood pressure management.

Postoperative optimization with adequate pain management, postoperative chewing gum, encouraging early oral intake, mobilization, breastfeeding and catheter removal.

 
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