| CTRI Number |
CTRI/2025/08/093510 [Registered on: 22/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparison between two of groups of pregnant women receiving hydration prior and during the cesarean section and their effect on the wellbeing of the newborn |
|
Scientific Title of Study
|
A Comparison of effect of preloading versus coloading on umbilical arterial pH in parturients undergoing elective cesarean section
A randomized controlled 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 |
Dr Shreeba B V |
| Designation |
post graduate |
| Affiliation |
Bangalore Medical College and Research Institute , RGUHS |
| Address |
Department of Anaesthesiology, Bangalore Medical College and Research Institute, New Tharagupet, KR Market , Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9591453399 |
| Fax |
|
| Email |
shree5396@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nethra S S |
| Designation |
Professor |
| Affiliation |
Bangalore Medical College and Research Institute , RGUHS |
| Address |
Department of Anaesthesiology, Bangalore Medical College and Research Institute, New Tharagupet, KR Market , Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9019397665 |
| Fax |
|
| Email |
nethrassurhone@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shreeba B V |
| Designation |
post graduate |
| Affiliation |
Bangalore Medical College and Research Institute , RGUHS |
| Address |
Department of Anaesthesiology, Bangalore Medical College and Research Institute, New Tharagupet, KR Market , Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9591453399 |
| Fax |
|
| Email |
shree5396@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore Medical College and Research Institute, Bangalore, India, 560002 |
|
|
Primary Sponsor
|
| Name |
Bangalore Medical college and Research Institute |
| Address |
New Tharagupet , KR Market , Bangalore , 560002 |
| Type of Sponsor |
Government medical college |
|
|
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 Shreeba B V |
Vani Vilas Hospital |
Department of Anaesthesiology,3rd floor operation theatre complex ,New Tharagupet , KR market, Bangalore , 560002
Bangalore
KARNATAKA |
9591453399
shree5396@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Bangalore Medical College and Research Institute |
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 |
| Comparator Agent |
nil |
nil |
| Intervention |
Randomized controlled trial |
In this trial the study subjects are enrolled into two groups randomly ( computer based randomization ), further preloading group is taken as a control group and the umbilical arterial pH is compared amongst two groups. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
a)parturients willing to give informed consent
b)ASA status II
c)height measuring between 150-170cms
d)elective cesarean sections done under subarachinoid block |
|
| ExclusionCriteria |
| Details |
a)any contraindications to subarachinoid block
b)known hypersensitivity to local anaesthetics
c)complicated pregnancies
d)obesity
e)inadequate subarachinoid block |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Umbilical Arterial pH
APGAR scores |
Umbilical arterial blood sample collected immediately after delivery of the baby
APGAR scores recorded at 1min and 5mins after the birth of baby |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| hemodynamic parameters of the mother |
hemodynamic parameters recorded from pre-operative period till the end of the surgery |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
17/09/2025 |
| 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="0"
Months="0"
Days="30" |
|
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
|
This study will enroll parturients undergoing elective cesarean section under subarachinoid block randomly allocated into two groups, group P1 preloaded with 1oml/kg of body weight of crystalloids and group P2 coloaded with 10ml/kg of body weight of crystalloids . The umbilical arterial blood sample will be collected and hemodynamic parameters of the parturient will be recorded by an anaesthesiologist who will be blinded to whether the parturient was preloaded or coloaded. The umbilical arterial pH values and hemodynamic parameters of parturients will be compared between the two groups. |