| CTRI Number |
CTRI/2024/06/068804 [Registered on: 12/06/2024] Trial Registered Prospectively |
| Last Modified On: |
02/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating the effect of abdominal to hip circumference ratio on need for usage of medications for fall in blood pressure during caesarean delivery under spinal anaesthesia |
|
Scientific Title of Study
|
Effect of abdominal to hip circumference ratio on vasopressor requirement 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 |
Dr Ramesh K R |
| Designation |
PG Resident |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anesthesia and Intensive Care, ground floor, main operation theatre building, Safdarjung Hospital Campus, Ansari Nagar East, New Delhi, Delhi
New Delhi
DELHI
110029
India |
| Phone |
7356669616 |
| Fax |
|
| Email |
ramkrishnarkr97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parul Mullick |
| Designation |
Professor |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anesthesia and Intensive Care, ground floor, main operation theatre building, Safdarjung Hospital Campus, Ansari Nagar East, New Delhi, Delhi
New Delhi
DELHI
110029
India |
| Phone |
9810606262 |
| Fax |
|
| Email |
drparulmullick@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parul Mullick |
| Designation |
Professor |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anesthesia and Intensive Care, ground floor, main operation theatre building, Safdarjung Hospital Campus, Ansari Nagar East, New Delhi, Delhi
New Delhi
DELHI
110029
India |
| Phone |
9810606262 |
| Fax |
|
| Email |
drparulmullick@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhaman mahavir medical College and Safdarjung Hospital |
|
|
Primary Sponsor
|
| Name |
Vardhaman Mahavir Medical College and Safdarjung Hospital |
| Address |
Ansari nagar East, New Delhi, Delhi |
| 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 Ramesh K R |
VMMC and Safdarjung Hospital |
Safdarjung Hospital Campus, Ansari Nagar East, New Delhi, Delhi New Delhi DELHI
New Delhi
DELHI |
73566-69616
ramkrishnarkr97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O749||Complication of anesthesia duringlabor and delivery, unspecified, (2) ICD-10 Condition: O749||Complication of anesthesia duringlabor and delivery, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Primigravida with term singleton pregnancy scheduled for elective caesarean delivery under spinal anaesthesia
Age 20 years to 40 years, Weight 50kg to 70kg, Height 155cm to 165cm
American society of anaesthesiologists -grade2 |
|
| ExclusionCriteria |
| Details |
Parturients with known medical disorders
Known fetal anomalies
Any contraindications for spinal anaesthesia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the correlation between abdominal to hip circumference ratio and vasopressor requirement in parturients undergoing caesarean delivery under spinal anaesthesia |
0, 2min, 4min, 6min, 8min, 10min, 15min, 20min, 25min, 30min, 45min, 60min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the correlation between abdominal circumference and vasopressor requirement
To determine the correlation between hip circumference and vasopressor requirement
To determine the correlation between abdominal to hip circumference ratio and the incidence of hypotension. |
0, 2min, 4min, 6min, 8min, 10min, 15min, 20min, 25min, 30min, 45min, 60min |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
20/06/2024 |
| 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="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
|
Abdominal to hip circumference ratio which is measured preoperatively for parturients undergoing caesarean delivery under spinal anaesthesia will be correlated with requirement of vasopressor intraoperatively. |