| CTRI Number |
CTRI/2020/06/025719 [Registered on: 09/06/2020] Trial Registered Prospectively |
| Last Modified On: |
01/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Quantitative assessment of stomach contents before caesarean delivery |
|
Scientific Title of Study
|
Ultrasound assessment of gastric contents before Caesarean section - 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 |
Dr Shivani Wargantiwar |
| Designation |
Obstetric Anesthesia Fellow |
| Affiliation |
Rainbow childrens hospital hyderabad , telangana |
| Address |
Axon Anesthesia, 4th floor, OT complex, Rainbow childrens hospital, road no. 2, Banjara hills.
Hyderabad
TELANGANA
500034
India |
| Phone |
8860442106 |
| Fax |
|
| Email |
shivani236@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gita Nath |
| Designation |
Consultant Anesthesiologist |
| Affiliation |
Rainbow childrens hospital hyderabad , telangana |
| Address |
Axon Anesthesia, 4th floor, OT complex, Rainbow children hospital, road no. 2, Banjara hills.
Hyderabad
TELANGANA
500034
India |
| Phone |
9000241012 |
| Fax |
|
| Email |
drgitanath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR GITA NATH |
| Designation |
Consultant Anesthesiologist |
| Affiliation |
Rainbow childrens hospital hyderabad , telangana |
| Address |
AXON ANESTHESIA, 4TH FLOOR, OT COMPLEX, RAINBOW CHILDREN HOSPITAL, ROAD NO. 2, BANJARA HILLS
Hyderabad
TELANGANA
500034
India |
| Phone |
9000241012 |
| Fax |
|
| Email |
drgitanath@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rainbow childrens hospital, road no. 2, Banjara hills, Hyderabad, Telangana.500034 |
|
|
Primary Sponsor
|
| Name |
Rainbow Childrens Hospital |
| Address |
Road no. 2 Banjara hills, Hyderabad, Telangana, 500034. |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Shivani Wargantiwar |
Rainbow childrens hospital |
Obstetric OT, 4th floor
Hyderabad
TELANGANA |
8860442106
shivani236@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE RAINBOW CHILDRENS HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
All patients planned for Caesarean section. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage of study population with full stomach prior to Caesarean section CAESAREAN SECTION |
30 minutes before Caesarean section |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Antral cross sectional area(cm2) corelated with hours of fasting, percentage of labouring/non labouring patients and percentage of elective/emergency caesarean sections. |
30 minutes before caesarean section. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/06/2020 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The purpose of this study is to implement ultrasound as a bedside tool to know the incidence of full stomach in patients posted for caesarean section and correlate the antral cross-sectional area with the hours of fasting, labouring / non labouring patient and elective/emergency caesarean section. The type and volume of gastric contents could further help the anaesthesiologist in formulating an anesthetic plan that carries the least risk of aspiration or to postpone surgery, whenever feasible. If the patient is at risk of aspiration, then all the measures to decrease the risk of aspiration and its sequelae must be employed.
|