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CTRI Number  CTRI/2020/10/028398 [Registered on: 13/10/2020] Trial Registered Prospectively
Last Modified On: 28/09/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Postural Impact on Gastric Ultrasound assessment In Pregnancy  
Scientific Title of Study   Postural Impact on Gastric Ultrasound assessment In Pregnancy: An Observational Study  
Trial Acronym  PIGUP 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Yudhyavir Singh 
Designation  Assistant Professor 
Affiliation  All India Institute Of Medical Sciences,New Delhi 
Address  Department of Anaesthesia,Pain medicine,and Critical Care All India Institute Of Medical Sciences Ansari Nagar, New Delhi 110029

South
DELHI
110029
India 
Phone    
Fax    
Email  yudhyavir@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Soumya Sarkar 
Designation  Senior Resident 
Affiliation  All India Institute Of Medical Sciences,New Delhi 
Address  Department of Anaesthesia,Pain medicine,and Critical Care All India Institute Of Medical Sciences Ansari Nagar, New Delhi 110029

South
DELHI
110029
India 
Phone  8427483176  
Fax    
Email  soumyacmconline@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Soumya Sarkar 
Designation  Senior Resident 
Affiliation  All India Institute Of Medical Sciences,New Delhi 
Address  Department of Anaesthesia,Pain medicine,and Critical Care All India Institute Of Medical Sciences Ansari Nagar, New Delhi 110029


DELHI
110029
India 
Phone  8427483176  
Fax    
Email  soumyacmconline@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology Pain medicine and Critical care AIIMS New Delh 
 
Primary Sponsor  
Name  Department of Anaesthesiology Pain medicine and Critical care AIIMS New Delhi 
Address  Department of Anaesthesiology Pain medicine and Critical care AIIMS New Delhi Ansari Nagar New Delhi 110029  
Type of Sponsor  Research institution and hospital 
 
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 Yudhyavir Singh  All India Institute Of Medical Sciences,New Delhi   Ansari Nagar New Delhi 110029
South
DELHI 
9811140057

yudhyavir@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee,All India Institute Of Medical Sciences   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  42.00 Year(s)
Gender  Female 
Details  1.>18-year-old
2.Women with singleton pregnancy
3.Gestational age ≥ 36 weeks, not in active labour
4.Elective Cesarean Section
5.Pre pregnancy ASA physical status I & II
 
 
ExclusionCriteria 
Details  1.Any mental disorder
2.Patient refusal
3.Emergency Caesarean Section
4.Pre pregnancy body mass index greater than 30
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
assessment of the impact of different positioning on qualitative assessment of gastric volume in non-labouring pregnant patients at term.   An ultrasound assessment of the antrum will be done for the first time at 8 hours of solid and 2 hours for clear liquid fasting. Thereafter, the antrum area will be examined 10 mins after ingestion of 100 ml water. Subjects will be scanned in supine and right lateral position in a medical cot with the upper part at 0o, 30o and 45o. Each assessment will be performed 20 s after each change in bed and body position, and each to be completed within 40 s.
 
 
Secondary Outcome  
Outcome  TimePoints 
Gastric emptying of clear fluid in pregnancy  An ultrasound assessment of the antrum will be done for the first time at 8 hours of solid and 2 hours for clear liquid fasting. Thereafter, the antrum area will be examined 10 mins after ingestion of 100 ml water. Subjects will be scanned in supine and right lateral position in a medical cot with the upper part at 0o, 30o and 45o. Each assessment will be performed 20 s after each change in bed and body position, and each to be completed within 40 s. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   02/11/2020 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   To be published when the study will be completed.  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Gastric physiology in pregnancy is not well understood. Conventionally all term pregnant women are treated as ‘full stomach’ with increased risk of aspiration due to upward displacement of the stomach by the gravid uterus, progesterone-induced relaxation of the lower oesophageal sphincter, and comparatively lower gastric ph. Gastric ultrasound has emerged as a useful point-of-care tool for pre-operative estimation of gastric contents and volume. However, gastric ultrasound is technically more challenging in pregnancy due to upward displacement of the stomach, the rotation of the stomach into a more horizontal position, and an increase in respiratory rate. Probe placement also becomes difficult due to the steep angle between the xiphoid and the abdomen. Gastric contents are affected by gravity and body position. The posture of the patient may influence the consistency and reliability of qualitative and quantitative ultrasound assessments It has been seen that raising the upper section of the bed significantly alters the assessment of gastric fluid contents using the Perlas qualitative grading scale in non-pregnant healthy adult volunteers. Thus, the primary objective of our study is to assess the impact of different positioning on qualitative assessment of gastric volume in non-labouring pregnant patients at term.

 
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