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CTRI Number  CTRI/2025/07/089998 [Registered on: 02/07/2025] Trial Registered Prospectively
Last Modified On: 01/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Difference in post-operative outcomes in patients after C-section undergoing traditional pathway care vs ERAS pathway 
Scientific Title of Study   Clinical post operative outcomes in patients undergoing Elective LSCS:Comparing ERAS and Tradition Management – A Randomized Trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Taskeen Rehman 
Designation  Junior Resident  
Affiliation  AIIMS Guwahati 
Address  Room no. 60, OPD block, Department of Obstetrics and Gynecology All India institute of medical science, GUWAHATI, Silbharal, Changsari, Assam

Kamrup
ASSAM
781101
India 
Phone  8302478844  
Fax    
Email  taskeenbkn@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Saswati Tripathi 
Designation  Professor 
Affiliation  AIIMS Guwahati 
Address  Room no. 60, OPD block, Department of Obstetrics and Gynecology All India institute of medical science, GUWAHATI, Silbharal, Changsari, Assam

Kamrup
ASSAM
781101
India 
Phone  9600134042  
Fax    
Email  saswatitripathy@aiimsguwahati.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Saswati Tripathi 
Designation  Professor 
Affiliation  AIIMS Guwahati 
Address  Room no. 60, OPD block, Department of Obstetrics and Gynecology All India institute of medical science, GUWAHATI, Silbharal, Changsari, Assam

Kamrup
ASSAM
781101
India 
Phone  9600134042  
Fax    
Email  saswatitripathy@aiimsguwahati.ac.in  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  AIIMS Guwahati 
Address  AIIMS Guwahati, Changsari, Kamrup, 781101 
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 Taskeen Rehman  AIIMS Guwahati  Room no. 60, OPD block, Department of Obstetrics and Gynecology All India institute of medical science, GUWAHATI, Silbharal, Changsari, Assam
Kamrup
ASSAM 		 8302478844

taskeenbkn@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS Guwahati  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ERAS group   Received care as per evidence-based ERAS protocol including early oral intake, early ambulation, multimodal analgesia, and early catheter removal. Analysis within 24 hours of LSCS and post operative day 10 and 42 
Comparator Agent  Traditional group   Received standard institutional care involving delayed oral intake, routine opioid use, delayed ambulation and catheter removal. Analysis within 24 hours of LSCS and post operative day 10 and 42 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Pregnant women at term with ASA physical status I or II. 
 
ExclusionCriteria 
Details  Patients with cardiac disease, uncontrolled hypertension or diabetes, autoimmune disorders, thyroid dysfunction, placental abnormalities, severe hepatic or renal dysfunction, neurological or psychiatric illness, or contraindications for spinal anaesthesia such as coagulopathy. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary outcome: Quality of recovery assessed by QoR-11 score within 24 hours postoperatively.
Secondary outcomes: Length of hospital stay, Well’s score, maternal satisfaction, pain scores, early breastfeeding initiation, ambulation, catheter removal timing, readmission rates.
 		 Within 24 hours of LSCS, post-operative day 10 and day 42 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcomes: Length of hospital stay, Well’s score, maternal satisfaction, pain scores, early breastfeeding initiation, ambulation, catheter removal timing, readmission rates.
 		 Within 24 hours of LSCS, post-operative day 10 and day 42 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   15/07/2025 
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 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 - All of the individual participant data collected during the trial, after de-identification.

  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 - Any purpose.

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

  6. For how long will this data be available start date provided 01-07-2025 and end date provided 01-07-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

To compare clinical outcomes in patients undergoing LSCS based on ERAS and traditional postoperative care protocols.

Primary objective

To assess clinical outcomes in patients undergoing LSCS through ERAS versus traditional pathways.

Secondary objectives

To compare maternal satisfaction, readmission rates within 30 days, incidence of thromboembolic events, hospital cost per patient, and the need for additional post-discharge medical consultations.

To compare patient’s satisfaction and post operative complications between ERAS and traditional care protocols.

 

Study participants : All pregnant females scheduled for elective LSCS at term gestation who give written informed conset(can be taken by post graduate students or interns) at AIIMS Guwahati.

Inclusion criteria:

•          Pregnant women at term with ASA physical status I or II.

Exclusion criteria:

•          Patients with cardiac disease, uncontrolled hypertension or diabetes, autoimmune disorders, thyroid dysfunction, placental abnormalities, severe hepatic or renal dysfunction, neurological or psychiatric illness, or contraindications for spinal anaesthesia such as coagulopathy.

Study design : Prospective, single-center, randomized controlled trial.

Study setting and period : Department of Obstetrics and Gynaecology, AIIMS Guwahati over an 18-month period.

Intervention

Participants randomized into two groups:

ERAS group: received care as per evidence-based ERAS protocol including early oral intake, early ambulation, multimodal analgesia, and early catheter removal.

Traditional group: received standard institutional care involving delayed oral intake, routine opioid use, delayed ambulation and catheter removal.

Eligible patients will be identified during preoperative evaluation and approached by a research team member to explain the study purpose, methodology, and benefits. Written informed consent will be obtained, and baseline demographic and clinical information collected. Participants will then be randomized into either the ERAS protocol group or traditional care group using a sealed envelope method.

Study Instruments and Tools

1. QoR-11 questionnaire (Quality of Recovery-11)

2. Visual analog scale (VAS) for pain

3. Well’s score for deep vein thrombosis (DVT) risk 
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