| CTRI Number |
CTRI/2026/01/101348 [Registered on: 16/01/2026] Trial Registered Prospectively |
| Last Modified On: |
15/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Randomized Controlled Trial on the Effectiveness of a Modified Enhanced Recovery After Surgery Protocol (mERAS) in Reducing Surgical Site Infection Following Emergency Cesarean Delivery. |
|
Scientific Title of Study
|
Effectiveness of a Modified Enhanced Recovery After Surgery (mERAS) Protocol in Reducing Surgical Site Infection After Emergency Cesarean Delivery: A Randomized Controlled Trial.” |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vibha Rani Pipal |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
OPD Room no 150, Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, Gorakhpur
Kunraghat
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9799745624 |
| Fax |
|
| Email |
vibha2005kgmu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vibha Rani Pipal |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
OPD Room no 150, Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, Gorakhpur
Kunraghat
UTTAR PRADESH
273008
India |
| Phone |
9799745624 |
| Fax |
|
| Email |
vibha2005kgmu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vibha Rani Pipal |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
OPD Room no 150, Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, Gorakhpur
Kunraghat
UTTAR PRADESH
273008
India |
| Phone |
9799745624 |
| Fax |
|
| Email |
vibha2005kgmu@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Kunraghat, Gorakhpur, Uttar Pradesh, India
Pin 273008 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vibha Rani Pipal |
All India Institute of Medical Sciences |
OPD Room no 150, Department of Obstetrics and Gynecology, Kunraghat
Gorakhpur
UTTAR PRADESH |
09799745624
vibha2005kgmu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IHEC/AIIMS-GKP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, (2) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group – Standard Care |
Routine fasting and delayed feeding.
Catheter removal after 24 hours.
Ambulation after 24 hours.
Analgesia and care as per conventional hospital practice.
|
| Intervention |
Modified ERAS Protocol for Emergency Cesarean |
Preoperative
Minimal preoperative fasting allowed as per safety (e.g. clear fluids up to 2 h, solids 6 h when
feasible in emergency context). Preoperative counselling (brief) about early mobilization,
pain management, and feeding.
Intraoperative
Standard prophylactic antibiotics as per institutional protocol (ensuring timely administration,
e.g. 30–60 min before incision). Measures to maintain normothermia (warmed fluids,
blankets if available).
Postoperative
Multimodal analgesia (e.g. paracetamol + NSAID + regional techniques as applicable) to
reduce opioid use.
Early removal of urinary catheter (e.g. within 12–24 h if stable).
Early oral intake (clear liquids, then soft diet as tolerated).
Early mobilization (first ambulation within 6–12 h where clinically feasible).
Standard wound care with structured wound inspection schedule. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women undergoing emergency cesarean delivery (any indication).
Willing to provide informed consent and comply with follow-up (up to 30 days post-
surgery). |
|
| ExclusionCriteria |
| Details |
Elective cesarean deliveries.
Known immunocompromised state (e.g. HIV with low CD4, long-term steroids,
chemotherapy).
Severe comorbidities (e.g., uncontrolled diabetes, severe anaemia, chronic kidney or
chronic liver disease, ICU admissions).
Pre-existing infection at or near the proposed incision site.
Ongoing systemic antibiotic therapy for other infections at the time of surgery (beyond
routine prophylaxis).
Refusal to participate or inability to follow up (e.g. no reachable contact). |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence of Surgical Site Infection (SSI) as per CDC criteria within 4 weeks of emergency cesarean delivery,
defined as per CDC criteria (superficial, deep, or organ/space SSI). |
Incidence of Surgical Site Infection (SSI) within 4 weeks of emergency cesarean delivery,
defined as per CDC criteria (superficial, deep, or organ/space SSI). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time to first ambulation (hours after surgery). |
6-24 hours |
| Time to return of bowel function (time to first flatus and/or first bowel movement). |
6-24 hours |
| Postoperative pain scores |
6,24 and 48 hours |
| Duration of postoperative hospital stay (in days). |
3-7 days |
Patient satisfaction with perioperative care, measured at discharge using a structured,
validated satisfaction questionnaire (e.g. Likert scale). |
3-7 days |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
26/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
26/01/2026 |
| 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 Yet Recruiting |
| 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
|
Enhanced Recovery After Surgery (ERAS) is a comprehensive, evidence-based approach designed to minimize the physiological stress associated with surgical procedures, facilitate functional recovery, reduce complications, and shorten hospital stays. Initially developed for colorectal and significant abdominal surgeries, the ERAS principles have since been adapted to obstetric care, particularly in cesarean deliveries. These guidelines focus on optimizing various aspects of post-surgical care, such as pain management, early mobilization, fluid management, nutritional support, and encouraging early contact between mother and infant.
Guidelines from the ERAS Society delineate specific recommendations tailored for peri-cesarean care, which can be applied in both elective and emergency contexts. Research has led to the establishment of a modified ERAS (mERAS) protocol that prioritizes certain postoperative factors—such as facilitating early oral intake, implementing multimodal analgesia, promoting early movement, and ensuring prompt removal of urinary catheters—with evidence suggesting that these modifications can be safely employed in emergency situations, based on studies of emergent colorectal surgeries.
However, emergency cesarean deliveries present unique challenges. These include the urgency of the procedure, variability in preoperative preparation, a heightened baseline risk of infection, and the limited time available for preparatory measures. Therefore, it is essential to investigate whether implementing modified ERAS protocols can yield benefits, such as a reduction in surgical site infections (SSIs), while ensuring the safety of both mothers and their newborns. Current evidence supporting the application of ERAS in emergency cesarean deliveries remains less robust compared to that for elective cesarean births. |