| CTRI Number |
CTRI/2025/11/097841 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Association of blood value of uric acid to fall in BP after giving anaesthesia for cesearean section |
|
Scientific Title of Study
|
Association of serum uric acid levels with post spinal hypotension during caesarean delivery an observational study in parturients with and without preeclampsia |
| 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 Shamitha R |
| Designation |
Post-graduate |
| Affiliation |
Rajarajeswari Medical College and Hospital |
| Address |
Department of Anaesthesialogy Rajarajeswari Medical College and Hospital,Mysore road,kambipur,Banglore,KARNATAKA
Bangalore
KARNATAKA
560074
India |
| Phone |
6362197947 |
| Fax |
|
| Email |
shamitharavishankar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nadia rose |
| Designation |
Professor |
| Affiliation |
Rajarajeswari Medical College and Hospital |
| Address |
Department of Anaesthesialogy Rajarajeswari Medical College and Hospital,Mysore road,kambipur,Banglore,KARNATAKA
Bangalore
KARNATAKA
560074
India |
| Phone |
9513454567 |
| Fax |
|
| Email |
dr.nadia.rose@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nadia rose |
| Designation |
Professor |
| Affiliation |
Rajarajeswari Medical College and Hospital |
| Address |
Department of Anaesthesialogy Rajarajeswari Medical College and Hospital,Mysore road,kambipur,Banglore,KARNATAKA
Bangalore
KARNATAKA
560074
India |
| Phone |
9513454567 |
| Fax |
|
| Email |
dr.nadia.rose@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajarajeswari Medical College and Hospital ,Mysore Road,Kambipura,Banglore KARNATAKA 560074 India |
|
|
Primary Sponsor
|
| Name |
Dr Shamitha R |
| Address |
Rajarajeswari Medical College and Hospital ,Mysore Road,Kambipura,Banglore KARNATAKA 560074 India |
| 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 |
| Shamitha R |
Rajarajeswari medical college and hospital |
Ot complex,department of anaesthesiology,Rajarajeswari medical college and hospital,mysore road,Kambipura,Banglore
Bangalore
KARNATAKA |
6362197947
shamitharavishankar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajarajeswari medical college and hospital institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Parturients undergoing emergency caesarean section under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
preexisting coagulation abnormalities
hyperuricemia before pregnancy
twin pregnancy
abnormal placenta
polyhydraminos
oligohydraminos
gestation less than 34weeks
use of general anaesthesia and epidural anaesthesia
height less than 150cm and more than 180cm
contraindication for spinal anaesthesia
eclampsia
medical disorders like cardiac disease ,chronic hypertension, renal disease ,endocrine disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the association between hyperuricemia and the incidence of post spinal hypotension in parturients with and without pre-eclampsia undergoing emergency caesarean section under subarachnoid blockade
|
1,3,5,10 minutes after subarachnoid block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the need for supplemental uterotonic agents |
after delivery of baby to end of surgery |
|
|
Target Sample Size
|
Total Sample Size="190"
Sample Size from India="190"
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)
|
18/12/2025 |
| 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="2"
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
|
Uric acid is the final metabolite of purine metabolism and is mainly excreted by kidneys and intestine.
Uterine contractions during labour causing repeated ischemia and reperfusion can lead to rise in production of reactive oxygen species and
increase serum uric acid levels.
Pre-eclampsia is commonly associated with elevated serum uric acid (UA) levels, which is mainly thought to be due to renal impairment and
breakdown of purines from maternal, foetal, and placental tissues. Raised uric acid levels is considered a marker of hypertension, also it is
related to lesser use of vasopressors following spinal anaesthesia . There are studies that have established a positive correlation between hyperuricemia and decreased fall in blood pressure following spinal
anaesthesia in pre-eclamptic patients.
This study aims to evaluate the relationship between hyperuricemia and hypotension in parturients who have pre-eclampsia as well as
parturients who do not have pre-eclampsia. |