| CTRI Number |
CTRI/2024/05/068218 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
31/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How Belly Size Affects Low Blood Pressure During C-Section with Spinal Anesthesia |
|
Scientific Title of Study
|
Effect of symphysiofundal height on the incidence of hypotension 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 Manupati Naren |
| Designation |
PG Resident |
| Affiliation |
Vardhman Mahavir Medical College 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 |
8143395179 |
| Fax |
|
| Email |
naren.manupati809@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parul Mullick |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir Medical College 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 |
Vardhman Mahavir Medical College 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 Manupati Naren |
VMMC and Safdarjung Hospital |
Department of anaesthesia and intensive care, Ansari nagar east,
New Delhi
DELHI |
8143395179
naren.manupati809@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 |
| Healthy Human Volunteers |
Full Term Pregnant |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Parturients with term (37 to 40 weeks gestation) singleton pregnancy scheduled for elective caesarean delivery
Age 20 to 40 years, weight 50 to 70 kg and height 155 to 165 cm
American Society of Anaesthesiologists grade II |
|
| ExclusionCriteria |
| Details |
Parturients with complicated pregnancy
Known foetal anomalies
Contraindication for spinal anaesthesia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine correlation between symphysiofundal height and incidence of hypotension 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 correlation of symphysiofundal height with maximum level of sensory
block and to determine correlation of symphysiofundal height with vasopressor requirement |
2min, 4min, 6min, 8min, 10min, 12min, 14min |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
15/06/2024 |
| 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="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
|
Symphysiofundal height is measured preoperatively for the parturients who are undergoing caesarean delivery under spinal anaesthesia will be correlated with incidence like hypotension, maximum level of senosry block and need for vasopressor requirement. |