| CTRI Number |
CTRI/2025/11/097831 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
21/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [benefits of oral hydration over infusionntravenousi] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the benefits Of Early Oral Hydration Over Late Oral Hydration Immediately After Caesarean Section |
|
Scientific Title of Study
|
Early Oral Feeding Versus Conventional Late Oral Feeding For Postoperative Management Of Caesarean Section Performed Under Regional Anaesthesia |
| Trial Acronym |
no |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nadim Ul Haque |
| Designation |
Post graduate trainee |
| Affiliation |
IPGMER and SSKM |
| Address |
IPGMER and SSKM doctors hostel ,Harish Mukherjee road ,bhowanipore
Kolkata
WEST BENGAL
700020
India |
| Phone |
8420209358 |
| Fax |
|
| Email |
nadim91.nh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Doctor Professor Narayan Jana |
| Designation |
Professor,Head of department, obstertics and gynecology |
| Affiliation |
IPGMER and SSKM |
| Address |
IPGMER and Sskm hospital, department of obstetrics and gynecology, bhowanipore ,kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9331035392 |
| Fax |
|
| Email |
drnjana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Doctor Professor Narayan Jana |
| Designation |
Professor,Head of department, obstertics and gynecology |
| Affiliation |
IPGMER and SSKM |
| Address |
IPGMER and Sskm hospital, department of obstetrics and gynecology, bhowanipore ,kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9331035392 |
| Fax |
|
| Email |
drnjana@gmail.com |
|
|
Source of Monetary or Material Support
|
| Departmental fund
Department of obstetrics and
gynaecology
Institute of Postgraduate Medical Education and Research
244, AJC Bose Road, Kolkata 700020 |
|
|
Primary Sponsor
|
| Name |
Nadim Ul Haque |
| Address |
IPGMER and SSKM,Bhowanipore, kolkata, 700020 |
| Type of Sponsor |
Other [Self] |
|
|
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 Nadim Ul Haque |
Labour ward and Postnatal ward, Department of Obstetrics and Gynaecology IPGMER and SSKM Hospital |
244, A.J.C Bose road, Kolkata 700020
Kolkata
WEST BENGAL |
8420209358
nadim91.nh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGMER Research Oversight Committee |
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 |
Early oral feeding initiated soon after LUCS and followed up till discharge. |
oral fluid will be started 4 hours after LUCS and will be continued till discharge. |
| Comparator Agent |
IV fluid started for initial 6 hours after LUCS and then shifted to oral liquid. |
oral liquid is started after 6 hours of LUCS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
Singleton pregnancy, term gestation 37- 42 weeks, low risk status. |
|
| ExclusionCriteria |
| Details |
High risk pregnancies including those with preexisting medical conditions , previous ceaseran delivery, or pregnancies requiring induction of labor. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain score, return of Intestinal Peristaltic Sound, nausea and vomiting |
Date and time of Operation is considered as Day-1, 0 (zero) hour; Assessment will be done at 2 hours, 4 hours, 6 hours, 12 hours, 24 hours (Day1 completed), and then Day 2, Day 3, Day 4, Day 5, Day 6 , Day 7 of operation; and on the day of Discharge. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Surgical site infection, return of appetite, early ambulation, initiation of breastfeeding |
Date & time of Operation is considered as Day-1, 0 (zero) hour; Assessment will be done at 2 hours, 4 hours, 6 hours, 12 hours, 24 hours (Day1 completed), & then Day 2, Day 3, Day 4, Day 5, Day 6 , Day 7 of operation; & on the day of Discharge. |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
02/12/2025 |
| 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="3"
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 - NO
|
|
Brief Summary
|
Women who had Caesarean section under spinal anaesthesia with uneventful operative procedure were included in study . The population did not have any major medical or surgical comorbidities/complications prior to or during pregnancy, and labour. They will fulfill predefined inclusion and exclusion criteria , and they will criteria included in the proposed study .We will conduct a prospective, randomized controlled trial[open label] to compare the effects of early oral feeding to late oral feeding during the post caesarean section period . The statistical analysis will enable us to draw meaningful conclusions from the data, specifically regarding the efficacy of early oral feeding compare to late oral feeding during post caesarean section period. Feeding and hydration methods are clinically very relevant because it greatly affects physical and psychological wellbeing of mothers. At early oral feeding enhance mobilization of mothers in postoperative period it is likely to enhance early breast feeding of neonates. |