| CTRI Number |
CTRI/2025/09/094104 [Registered on: 02/09/2025] Trial Registered Prospectively |
| Last Modified On: |
01/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
This thesis aims to study whether there is any association between preoperative perfusion index and hypothermia in pregnant women undergoing caesarean delivery under spinal anaesthesia |
|
Scientific Title of Study
|
Evaluation of preoperative perfusion index as a predictor of perioperative hypothermia in parturients undergoing caesarean delivery under spinal anaesthesia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vaishali Giri Goswami |
| Designation |
Post graduate resident |
| Affiliation |
Vardhman mahavir medical College and safdarjung hospital |
| Address |
Vardhman mahavir medical College and safdarjung hospital New Delhi
110029
South
DELHI
110029
India |
| Phone |
9582826504 |
| Fax |
|
| Email |
Vaishali23031999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parul Mullick |
| Designation |
Director professor and consultant Vardhman mahavir medical College and safdarjung hospital |
| Affiliation |
Vardhman mahavir medical College and safdarjung hospital |
| Address |
Vardhman mahavir medical College and safdarjung hospital New Delhi
South
DELHI
110029
India |
| Phone |
9810606262 |
| Fax |
|
| Email |
drparulmullick@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parul Mullick |
| Designation |
Director professor and consultant Vardhman mahavir medical College and safdarjung hospital |
| Affiliation |
Vardhman mahavir medical College and safdarjung hospital |
| Address |
Vardhman mahavir medical College and safdarjung hospital New Delhi
Baghpat
DELHI
110029
India |
| Phone |
9810606262 |
| Fax |
|
| Email |
drparulmullick@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman mahavir medical College and safdarjung hospital
New Delhi
India
110029 |
|
|
Primary Sponsor
|
| Name |
Vardhman mahavir medical College and safdarjung hospital |
| Address |
Vardhman mahavir medical College and safdarjung hospital New Delhi
India
1100029 |
| 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 Vaishali Giri Goswami |
Vardhman mahavir medical College and safdarjung hospital |
Vardhman mahavir medical College and safdarjung hospital
Department of anesthesia
New Delhi India
South
DELHI |
9582826504
Vaishali23031999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vmmc and safdarjung hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Term parturients with singleton pregnancy |
|
| ExclusionCriteria |
| Details |
Hypertension, thyroid disorder,on medication affecting thermoregulation, preoperative temperature more than 38 degree Celsius or less than 36 degree Celsius , obesity body mass index greater than 40 , peripheral vascular disease , pre existing ear disease, impacted cerumen or anomaly of auditary canal, any contraindication to spinal anaesthesia , participants requiring intraoperative blood transfusion, participants requiring conversion to general anesthesia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| In parturients undergoing caesarean delivery under spinal anaesthesia, outcome measures noted are perfusion index and hypothermia by measuring ear temperature |
Baseline
Till end of surgery
Recovery room |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Shivering incidence and severity using crossly and mahajan score, maternal thermal comfort score and neonatal apgar score |
Intraoperative and postoperative |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
12/09/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
In this thesis association between preoperative perfusion index and perioperative hypothermia in parturients undergoing caesarean delivery under spinal anaesthesia will be studied. Thus we can prevent the incidence of hypothermia in source limited areas by predicting before the operation. |