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CTRI Number  CTRI/2023/09/057875 [Registered on: 20/09/2023] Trial Registered Prospectively
Last Modified On: 16/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Studying the time taken for stomach to get empty after taking food by performing an ultrasound in normal weight and overweight pregnant women who are planned for delivery by surgery.  
Scientific Title of Study   Ultrasonographic evaluation of gastric emptying time in obese and non-obese full term pregnant women planned for elective caesarean section following standardized meal. 
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 Apurva Sinha 
Designation  Post graduate resident 
Affiliation  Maulana Azad Medical College 
Address  Department of Anaesthesiology Room no.305 3rd floor BL Taneja Block Maulana Azad Medical College Bahadur Shah Zafar Marg New Delhi

Central
DELHI
110002
India 
Phone  8076612477  
Fax    
Email  apurva411@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Neelam Prasad 
Designation  Director Professor 
Affiliation  Maulana Azad Medical College 
Address  Department of Anaesthesiology Room no. 305 3rd floor BL Taneja Block Maulana Azad Medical College Bahadur Shah Zafar Marg New Delhi

Central
DELHI
110002
India 
Phone  9968604372  
Fax    
Email  nprasadgovil@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Apurva Sinha 
Designation  Post graduate resident 
Affiliation  Maulana Azad Medical College 
Address  Department of Anaesthesiology Room no. 305 3rd floor BL Taneja Block Maulana Azad Medical College Bahadur Shah Zafar Marg New Delhi

Central
DELHI
110002
India 
Phone  8076612477  
Fax    
Email  apurva411@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad Medical College and associated Lok Nayak Hospital Bahadur Shah Zafar Marg New Delhi-110002 
 
Primary Sponsor  
Name  Maulana Azad Medical College 
Address  Maulana Azad Medical College Bahadur Shah Zafar Marg New DElhi Delhi-110002 
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 Apurva Sinha  Lok Nayak Hospital  Department of Anaesthesiology Room no.305 3rd floor BL Taneja Block Bahadur Shah Zafar Marg New Delhi-110002
Central
DELHI 		 8076612477

apurva411@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Maulana Azad Medical College and associated hospital (Lok Nayak, G.B. Pant Institute of Postgraduate Medical Education(GIPMER) and Research Hospital, Guru Nanak Eye Centre, New Delhi-110002 (Institutional ethics Committee)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy non-pregnant women with BMI 18.5-24.9 kg/m2 
Patients  (1) ICD-10 Condition: O749||Complication of anesthesia duringlabor and delivery, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Assessment of gastric emptying  Gastric emptying between the three groups will be assessed using the gastric emptying fraction 15-90 min and by assessing the halftime of gastric emptying and number of women with empty stomach at 90min and 120 min after ingestion of meal. 
Intervention  Ultrasonographic evaluation of antral cross-sectional area after a standardized meal  The three groups of women (non-pregnant women, non-obese pregnant women and obese pregnant women) who volunteer to be a part of the study will be included in the study. After ensuring an adequate fasting, that is 6 hours for solids and 2 hours for clear liquids a baseline ultrasound examination will be done. Following this the volunteers will be made to consume a standardized meal- 100g flavoured yogurt (136kcal, 4.1g protein, 4.6g fat, 19.5g carbohydrates) and serial ultrasound of gastric antral cross section will be done at every 15 minutes for a total duration of 120 minutes.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  OBESE PREGNANT WOMEN:
Pregnant women 18-40 years of age
Body mass index ≥30kg/m2
American Society of Anaesthesiologists Grade 2
Singleton pregnancy

NON-OBESE PREGNANT WOMEN:
Pregnant women 18-40 years of age
Body mass index <30kg/m2
American Society of Anaesthesiologists Grade 2
Singleton pregnancy

NON-PREGNANT WOMEN:
Non-Pregnant women 18-40 years of age
Body mass index 18.5-24.9 kg/m2
American Society of Anaesthesiologists Grade 1 and Grade 2
 
 
ExclusionCriteria 
Details  OBESE PREGNANT WOMEN:
Esophageal, duodenal or gastric medical or surgical history
Obstetrical emergencies
Intake of gastric motility altering drugs (e.g., metoclopramide- intake of even a single dose of drug within the last 24h)
History of Diabetes mellitus >10 years
Allergy to dairy and dairy products
Aversion to consumption of yogurt

NON- OBESE PREGNANT WOMEN:
Esophageal, duodenal or gastric medical or surgical history
Obstetrical emergencies
Intake of gastric motility altering drugs (e.g., metoclopramide- intake of even a single dose of drug within the last 24h)
History of Diabetes mellitus >10 years
Allergy to dairy and dairy products
Aversion to consumption of yogurt

NON- PREGNANT WOMEN:
Esophageal, duodenal or gastric medical or surgical history
Intake of gastric motility altering drugs (e.g., metoclopramide- intake of drug within the last 24h)
History of Diabetes mellitus >10 years
Allergy to dairy and dairy products
Aversion to consumption of yogurt
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Antral cross sectional areas at 15 & 90 minutes after ingestion of meal.  Antral cross sectional areas at 15 & 90 minutes after ingestion of meal. 
 
Secondary Outcome  
Outcome  TimePoints 
Gastric emptying fraction from 15-90 minutes after ingestion of meal
 		 15 & 90 minutes after ingestion of meal 
Half time to gastric emptying  serial ultrasound measurements up to 120 minutes after ingestion of meal 
Number of women who had empty stomachs at 90 & 120 min after ingestion of test meal.  90 & 120 minutes after ingestion of meal 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/10/2023 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   Pulmonary aspiration of gastric contents is a rare but serious complication in obstetric anaesthesia and is associated with significant morbidity and mortality. Obesity results in a further increase in this risk because obesity is associated with hiatal hernia and increased intra-abdominal pressure which may further decrease the gastric emptying. This has led to a stringent adoption of preoperative fasting guidelines, that is six hours following solids and two hours following clear liquids. However there are no separate guidelines for fasting in obese patients. Gastric ultrasound is a non-invasive procedure which can be easily performed at bedside and help in rapid risk assessment of the patient.
Women admitted in the maternity ward of lok nayak hospital who fulfill the inclusion and exclusion criteria will be recruited for the study. A special note will be made of the height, weight and BMI of the patients in addition to a detailed pre-anaesthetic checkup. After ensuring an adequate fasting, that is six hours for solids and two hours for clear liquids, an ultrasound examination of abdomen will be performed using the available ultrasound machine equipped with a curvilinear probe (2 to 5 MHz) after making the patient lie in semi recumbent position with head elevated to 45degree. After obtaining a baseline value the participants will be made to ingest a standardized meal(100g flavoured yogurt: 136kcal, 4,1g protein, 4.6g fat, 19.5g carbohydrates) within 5 minutes and serial ultrasounds of gastric antral cross section will be measured at different time intervals-15min/90min/120min in a standardized saggital plane passing through abdominal aorta and left lobe of liver. Similar procedure will be followed for non-pregnant volunteer group as well.
The antral cross section area will be used to measure the gastric emptying fraction at 15-90 minutes and half time to gastric emptying. The number of women with empty stomachs at 90min and 120min after ingestion of meal will also be assessed.
For statistical analysis, comparison of normally distributed continous variables between the groups will be performed using ANOVA. Nominal categorical data between the groups will be compared using Chi-squared test or Fisher’s exact test and non-normal distribution categorical variables will be compared using Kruskal Wallis test and further paired comparisons will be done using Mann Whitney U test.
 
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