| CTRI Number |
CTRI/2025/07/091070 [Registered on: 17/07/2025] Trial Registered Prospectively |
| Last Modified On: |
16/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Diagnostic
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Using Ultrasound to check how empty the stomach is before a C-Section, depending on how long the mother has been fasting |
|
Scientific Title of Study
|
A study of gastric astral contents in relation to duration of fasting in cesarean section using Point of care Ultrasound (POCUS) |
| 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 Swathi SM |
| Designation |
Post Graduate |
| Affiliation |
Mahadevappa Rampure Medical College |
| Address |
Department of Anaesthesiology, 1st floor, Basaveshwara teaching and general Hospital,Sedam road , Rajapur, Kalaburagi
Gulbarga
KARNATAKA
585105
India |
| Phone |
7338551657 |
| Fax |
|
| Email |
swathiservegar4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lata A Shah |
| Designation |
Professor |
| Affiliation |
Mahadevappa Rampure Medical College |
| Address |
Department of Anaesthesiology, 1st floor, Basaveshwara teaching and general Hospital, Sedam road , Rajapur, Kalaburagi
Gulbarga
KARNATAKA
585105
India |
| Phone |
9731046446 |
| Fax |
|
| Email |
latads@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lata A Shah |
| Designation |
Professor |
| Affiliation |
Mahadevappa Rampure Medical College |
| Address |
Department of Anaesthesiology, 1st floor, Basaveshwara teaching and general Hospital , Sedam road , Rajapur, Kalaburagi
Gulbarga
KARNATAKA
585105
India |
| Phone |
9731046446 |
| Fax |
|
| Email |
latads@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Mahadevappa Rampure Medical College, Kalaburagi |
|
|
Primary Sponsor
|
| Name |
Dr Swathi SM |
| Address |
Department of Anaesthesiology, Mahadevappa Rampure Medical College, Rajapur, Sedam Road, Kalaburagi 585105 |
| 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 Swathi S M |
Basaveshwara Teaching and General Hospital |
Department of Anaesthesiology, 1st floor, Basaveshwara teaching and general Hospital, Sedam Road, Rajapur, Kalaburagi 585105
Gulbarga
KARNATAKA |
7338551657
swathiservegar4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| M R Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
PREGNANT WOMEN |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Ultrasound |
Ultrasound will be used to assess the Gastric antrum |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
PREGNANT WOMEN BETWEEN AGE 18-40 YEARS WITH ASA GRADE 2 (AMERICAN SOCIETY OF ANAESTHESIOLOGISTS) UNDERGOING CESAREAN SECTION UNDER SUB ARACHNOID BLOCK |
|
| ExclusionCriteria |
| Details |
Pregnant women with Gastric motility disorders, Upper Gastrointestinal disorders and Psychiatric disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To study gastric antral volume in relation to duration of fasting in cesarean section using point of care ultrasound (POCUS).
2.To study the type of gastric content in relation to duration of fasting in cesarean section using point of care ultrasound(POCUS). |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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 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
|
This study is to assess the Gastric antrum in relation to duration of fasting using point of care ultrasound (POCUS) to know the risk of aspiration in women undergoing Cesarean section. |