| CTRI Number |
CTRI/2025/04/083929 [Registered on: 02/04/2025] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ultrasound reliability to identify the volume status and severity of hypotension in pregnant hypertensive patients undergoing cesarian section under spinal anaesthesia. |
|
Scientific Title of Study
|
Point of care ultrasound in predicting severity of spinal hypotension and volume status in preeclamptic parturients posted for LSCS surgeries A Prospective observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pavithra Duraisamy |
| Designation |
Post graduate |
| Affiliation |
Institute of anaesthesiology, Madurai Medical college |
| Address |
Institute of Anaesthesiology,
Madurai Rajaji GOvernment hospital and Medical college,
Madurai
Namakkal
TAMIL NADU
625020
India |
| Phone |
9600728279 |
| Fax |
|
| Email |
dr.pavidurai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pavithra Duraisamy |
| Designation |
Post graduate |
| Affiliation |
Institute of anaesthesiology, Madurai Medical college |
| Address |
Institute of Anaesthesiology,
Madurai Rajaji govt hospital and medical college
Madurai
Namakkal
TAMIL NADU
625020
India |
| Phone |
9600728279 |
| Fax |
|
| Email |
dr.pavidurai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pavithra Duraisamy |
| Designation |
Post graduate |
| Affiliation |
Institute of anaesthesiology, Madurai Medical college |
| Address |
Institute of Anaesthesiology,
Madurai Rajaji govt medical college and hospital,
Madurai.
Namakkal
TAMIL NADU
625020
India |
| Phone |
9600728279 |
| Fax |
|
| Email |
dr.pavidurai@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Anaesthesiology,Madurai medical college,Madurai (dt),Tamil Nadu, India. Pincode-625020 |
|
|
Primary Sponsor
|
| Name |
DrVijaya G |
| Address |
Institute of Anaesthesiology,Madurai Medical college,Madurai - 625020 |
| 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 Vijaya G |
Madurai Rajaji Govt hospital |
Institue of Anaesthesiology,
Madurai medical college,Alwarpuram
Madurai
TAMIL NADU |
9443774381
doctorvijayag@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-Madurai medical college and govt Rajaji hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O140||Mild to moderate pre-eclampsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
ASS PS 2 and 3
Mild and moderate preeclampsia
Without multisystem involvement
Singleton pregnancy
|
|
| ExclusionCriteria |
| Details |
Severe preeclampsia
Other system involvement(cardiovascular/renal/cerebrovascular)
Abruptio placenta
Contraindications to spinal anaesthesia
Lack of consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
% of IVC CI in hypotension patients
Echo comet score in hypervolemic patients |
Baseline
5mins
10mins
15mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Vasopressor requirement |
Baseline
5mins
10mins
15mins |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
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)
|
10/04/2025 |
| 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="6" |
|
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
|
The primary objective of the study is to predict if the point of care ultrasound parameters like IVC CI and ECS are helpful to identify the severity of hypotension after spinal anaesthesia and also to predict the volume status in preeclampsia patients undergoing LSCS, as preeclampsia patients have very extreme volume status either hypo or hypervolemic and also blood pressure management is very crucial one in them. So an observational study is done to identify the predicting capacity of pocus parameters so that in future we can use these parameters to guide fluid management in pre eclamptic patients and also could predict the severity of hypotension prior to spinal anaesthesia. |