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CTRI Number  CTRI/2021/04/032643 [Registered on: 08/04/2021] Trial Registered Prospectively
Last Modified On: 07/04/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Observational 
Study Design  Single Arm Study 
Public Title of Study   Empty Stomach Assessment in Fasting Pregnant Women Using Ultrasound  
Scientific Title of Study   ASSESSMENT OF RESIDUAL GASTRIC VOLUME AFTER OVERNIGHT FASTING IN PREGNANT WOMEN: AN ULTRASOUND BASED 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 GIRISH SHARANAYYA HIREMATH 
Designation  JUNIOR RESIDENT 
Affiliation  Vijayanagar Institute of Medical Sciences 
Address  Department of Anaesthesiology Vijayanagar Institute of Medical Sciences, Cantonment, Ballari Bellary Department of Anaesthesiology Vijayanagar Institute of Medical Sciences, Cantonment, Ballari

Bellary
KARNATAKA
583104
India 
Phone  9449065507  
Fax    
Email  girish.sh4042@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR GIRISH SHARANAYYA HIREMATH 
Designation  JUNIOR RESIDENT 
Affiliation  Vijayanagar Institute of Medical Sciences 
Address  Department of Anaesthesiology Vijayanagar Institute of Medical Sciences, Cantonment, Ballari Bellary Department of Anaesthesiology Vijayanagar Institute of Medical Sciences, Cantonment, Ballari

Bellary
KARNATAKA
583104
India 
Phone  9449065507  
Fax    
Email  girish.sh4042@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Bala Bhaskar S 
Designation  Professor 
Affiliation  Vijayanagar Institute of Medical Sciences 
Address  Department of Anaesthesiology Vijayanagar Institute of Medical Sciences, Cantonment, Ballari Bellary Department of Anaesthesiology Vijayanagar Institute of Medical Sciences, Cantonment, Ballari

Bellary
KARNATAKA
583104
India 
Phone  9880012349  
Fax    
Email  sbalabhaskar@gmail.com  
 
Source of Monetary or Material Support  
Department of Obstetrics and Gynaecology and Department of Anaesthesiology Vijayanagara Institute of Medical Sciences, Ballari 
 
Primary Sponsor  
Name  Vijayanagar Institute of Medical Sciences 
Address  Vijayanagar Institute of Medical Sciences, Cantonment, Ballari, 583104 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Girish Sharanayya Hiremath  Vijayanagar Institute of Medical Sciences  Department of Anaesthesiology and Department of Obstetrics and Gynecology, Medical College Hospital, Cantonment, Ballari /Bellary- 583104
Bellary
KARNATAKA 		 9449065507

girish.sh4042@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vijayanagar Institute of Medical Sciences Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pregnant women posted for elective caesarean section 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1) All pregnant women of 18-35 years of age, > 36 weeks of gestation, admitted for elective obstetric indication, with one clear overnight inpatient stay preoperatively.
2) ASA physical status II. 
 
ExclusionCriteria 
Details  1) Patient refusal for the procedure.
2) Deviation from proposed fasting times or oral intake advice.
3) Body mass index (BMI) greater than 30 kg/m².
4) Uncontrolled diabetes mellitus.
5) Moderate to severe pre-eclampsia.
6) Hiatus hernia, intestinal disease, previous upper abdominal surgeries.
7) Patients taking H2 receptor blockers, proton pump inhibitors and prokinetic drugs or any other medication known to delay gastric emptying. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The residual gastric volume after overnight fasting in pregnant women.  At 6AM in the morning after overnight fasting. 
 
Secondary Outcome  
Outcome  TimePoints 
Antral grading and assessment for presence of solid food contents in the gastric antrum after overnight fasting.  At 6AM in the morning after overnight fasting. 
 
Target Sample Size   Total Sample Size="306"
Sample Size from India="306" 
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)   12/04/2021 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response (Others) -  Data abstracted as per the results and analysis

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  May contact scientific query e mail girish.sh4042@gmail.com

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - May contact scientific query e mail girish.sh4042@gmail.com
Brief Summary   Gastric ultrasound is valuable point of care ultrasonographic application for the assessment of content and volume, which may alter perioperative clinical management. Gravid uterus introduces variations ultrasound examination, the stomach tends to be displaced cephalad and right when compared to non-pregnant subjects, which would conceivably affect volume estimation. Models have been developed and subsequently implemented assessing the gastric volumes and the contents pregnant females. BN to assess the residue and gastric volume after overnight fasting in pregnant female patients admitted electively under ultrasound guidance. 
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