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
|
|
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
|
|
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
|
|
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. |