| CTRI Number |
CTRI/2018/05/014175 [Registered on: 29/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
23/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of early intake of water, juice or jelly on the post operative outcome of Caesaerean section |
|
Scientific Title of Study
|
To evaluate the effect of early feeding in the postoperative period on the outcome of Casearean section after spinal anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Meenoti Potdar |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Dr. Lakhumal Hiranand Hiranandani Hospital |
| Address |
Department of Anaesthesia,
Hiranandani Gardens, Hillside Avenue, Powai
Hiranandani Gardens, Hillside Avenue, Powai
Mumbai (Suburban)
MAHARASHTRA
400076
India |
| Phone |
9920627839 |
| Fax |
|
| Email |
meenoti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meenoti Potdar |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Dr. Lakhumal Hiranand Hiranandani Hospital |
| Address |
Department of Anaesthesia,
Hiranandani Gardens, Hillside Avenue, Powai
Hiranandani Gardens, Hillside Avenue, Powai
MAHARASHTRA
400076
India |
| Phone |
9920627839 |
| Fax |
|
| Email |
meenoti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavita Velankar |
| Designation |
Resident in Obstetric and Gynaecology |
| Affiliation |
Dr. Lakhumal Hiranand Hiranandani Hospital |
| Address |
Department of Obstetrics and Gynaecology,
Hiranandani Gardens, Hillside Avenue, Powai
Hiranandani Gardens, Hillside Avenue, Powai
Mumbai (Suburban)
MAHARASHTRA
400076
India |
| Phone |
9920627839 |
| Fax |
|
| Email |
kavitavelankar21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Lakhumal Hiranand Hiranandani Hospital
Department of Anaesthesia, Hiranandani Gardens, Hillside Avenue, Powai
Hiranandani Gardens, Hillside Avenue, Powai
Mumbai (Suburban)
MAHARASHTRA
400076
India
|
|
|
Primary Sponsor
|
| Name |
Dr L H Hiranandani Hospital |
| Address |
Hillside Avenue Hiranandani gardens Powai Mumbai |
| 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 Meenoti Potdar |
Dr L H Hiranandani Hospital |
Operation theatre recovery room, wards
Dr L H Hiranandani Hospital 2nd floor Hillside Avenue Hiranandani Gardens Powai Mumbai-400076
Mumbai (Suburban)
MAHARASHTRA |
9920627839
meenoti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Dr L H Hiranandani Hospital Powai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
1. ASA 2 pregnant patients
2. More than 36 weeks
3. Elective Caesarean section
4. Singleton pregnanacy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group C – Patients were destarved as per the conventional protocol |
Patients were destarved with sips of water after 4 hours followed by liquid diet by 6 hours and soft diet after 12 hours.
|
| Intervention |
Group E- Early Destarved within one hour postoperatively in recovery room |
Patients were destarved within one hour postoperatively in recovery room with sips of water followed by jelly. Patients were started with liquid diet within 3 hours and if well tolerated, soft diet given in 6 hours.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. ASA 2 pregnant patients
2. More than 36 weeks
3. Elective Caesarean section
4. Informed valid consent
5. Spinal anaesthesia for LSCS |
|
| ExclusionCriteria |
| Details |
1. Emergency LSCS
2. Controlled diabetic or hypertensive
3. General anaesthesia for LSCS |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Return of Bowel sounds
2. Incidence of nausea, vomiting |
1. Return of Bowel sounds - Immediated post operative perion in the recovery room
2. Incidence of nausea, vomiting - post operative period till first 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Time taken for ambulation and removal of IV cannula
2. Incidence of thirst, hunger and overall patients satisfaction
|
1. Time taken for ambulation and removal of IV cannula - within 24 hours post operative period
2. Incidence of thirst, hunger and overall patients satisfaction - During the first 24 hours post operatively
|
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
03/08/2015 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Notv yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
We have included uncomplicated,
elective LSCS where there is no or minimal Bowel handling.
The early feeding reduces the
incidence of thirst and hunger leading to improvement of hydration status &Rapid ret urn of bowel movement
The incidence of IV fluids given
also reduces in early feed group
We have given jelly to all over
early feed patients it reduces the incidence of nausea and vomiting |