| 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
|
|
|
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
|
|
|
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
|
|
|
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. |