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CTRI Number  CTRI/2026/02/103288 [Registered on: 09/02/2026] Trial Registered Prospectively
Last Modified On: 08/01/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   A study of stomach contents across the menstrual cycle: how hormonal changes influence fasting gastric volume 
Scientific Title of Study   Comparison of Fasting Gastric Volume in different Phases of Menstrual Cycle and Correlation with Hormonal Levels: A Prospective Observational Study Protocol 
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 Amit kumar 
Designation  Assistant Professor 
Affiliation  AIIMS, New Delhi 
Address  Room No. 4 5th floor Teaching block AIIMS New Delhi

New Delhi
DELHI
110029
India 
Phone  8055087505  
Fax    
Email  amit2007kr@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Amit kumar 
Designation  Assistant Professor 
Affiliation  AIIMS, New Delhi 
Address  ROOM NO 4 PORTA CABIN 5TH FLOOR TEACHING BLOCK ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI

New Delhi
DELHI
110029
India 
Phone  8055087505  
Fax    
Email  amit2007kr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Amit kumar 
Designation  Assistant Professor 
Affiliation  AIIMS, New Delhi 
Address  ROOM NO 4 PORTA CABIN 5TH FLOOR TEACHING BLOCK ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI

New Delhi
DELHI
110029
India 
Phone  8055087505  
Fax    
Email  amit2007kr@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences New Delhi 
Address  Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 
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 AMIT KUMAR  Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS  Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
South West
DELHI 
8055087505

amit2007kr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
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: Z409||Encounter for prophylactic surgery, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Follicular phase   Participants in follicular phase of menstrual cycle 
Comparator Agent  Luteal Phase  Participants in luteal phase of menstrual cycle 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  1. Regular menstrual cycles,
2. ASA classes 1 and 2,
3. Consenting to participate.
 
 
ExclusionCriteria 
Details  Irregular menstrual cycle
Hormone replacement therapy
Polycystic ovarian syndrome (PCOS)
Diabetes mellitus,
Gastroesophageal reflux disease,
Chronic kidney disease,
Body mass index more than 30
Pregnancy,
Medications affecting gastric motility,
Upper abdominal surgery history,
Postmenopausal status,
Hormonal contraception use,
Emergency surgery.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare fasting gastric volume quantitatively and qualitatively by ultrasound during the luteal versus follicular phases of the menstrual cycle in premenopausal females undergoing elective surgery.  Just before surgery 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the correlation between fasting gastric volume, cross sectional area (CSA), qualitative grade and serum female sex hormone levels during phases of menstrual cycle.  Just before surgery 
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
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)   01/02/2027 
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 Yet Recruiting 
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  

Pulmonary aspiration remains a serious perioperative complication, particularly in patients with full stomachs. Gastric ultrasonography (USG) serves as a reliable, non-invasive bedside tool to estimate gastric volume and contents, helping assess aspiration risk. Existing research indicates that gastric emptying and motility may be influenced by hormonal changes during different phases of the menstrual cycle, mediated through oestrogen and progesterone effects on smooth muscle tone and nitric oxide synthase pathways. However, the literature presents conflicting findings—some studies report faster gastric emptying in the luteal phase, while others document delayed emptying. Given this inconsistency, the proposed study aims to evaluate the effect of menstrual cycle phase (follicular vs. luteal) on fasting gastric volume in healthy female subjects using point-of-care gastric ultrasonography. The goal is to determine whether hormonal variations across the cycle have clinically relevant implications for preoperative fasting guidelines and aspiration risk assessment in women.

 
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