Ultrasound for Comparison of Gastric Antral Volume in Pregnants and Non-pregnants
1 other identifier
observational
63
0 countries
N/A
Brief Summary
This study evaluates the effectiveness of ultrasound in term pregnant patients posted for elective lower segment cesarean sections and compared them with non pregnant females posted for elective surgeries.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2016
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2017
CompletedFirst Submitted
Initial submission to the registry
December 15, 2017
CompletedFirst Posted
Study publicly available on registry
December 21, 2017
CompletedDecember 21, 2017
December 1, 2017
12 months
December 15, 2017
December 20, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Effectiveness of ultrasound in pregnants and non-pregnants in terms of visibility
The effectiveness is stated in terms of percentage visibility and compared in pregnants and non-pregnants.
October 2016 to October 2017
Secondary Outcomes (2)
Qualitative assessment of Gastric antrum
October 2016 to October 2017
Quantitative assessment of Gastric Antrum
October 2016 to October 2017
Study Arms (1)
Pregnant and non-pregnant females
The pregnant females posted for elective lower segment cesarean section and non-pregnant females posted for elective surgeries are scanned by ultrasound in the pre recovery room. The visibility of the gastric antrum is assessed. The qualitative and quantitative assessment is made and is compared.
Interventions
Sonosite ultrasound (Sonosite, FUJIFILM M-Turbo, made in USA)
Eligibility Criteria
The study population are term pregnants posted for elective lower segment cesarean section and non-pregnant patients posted for elective surgeries in PGIMER.
You may qualify if:
- Control group- Non-pregnant female patients, aged between 18 to 45 years, ASA I \& II, having BMI between 18.5 to 30 kg/m2, scheduled for elective surgery.
You may not qualify if:
- Gastrointestinal pathology
- On any medication delaying gastric motility
- Systemic lupus erythematosis
- Diabetes mellitus
- Gestational diabetes
- Hypothyroidism Those who were not willing to give consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Perlas A, Davis L, Khan M, Mitsakakis N, Chan VW. Gastric sonography in the fasted surgical patient: a prospective descriptive study. Anesth Analg. 2011 Jul;113(1):93-7. doi: 10.1213/ANE.0b013e31821b98c0. Epub 2011 May 19.
PMID: 21596885BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Snigdha Bellapukonda, MBBS
Post graduate institute of medical education and researchh
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Junior resident, MD Anesthesia, Department of Anesthesia and Intensive care
Study Record Dates
First Submitted
December 15, 2017
First Posted
December 21, 2017
Study Start
October 13, 2016
Primary Completion
October 10, 2017
Study Completion
October 10, 2017
Last Updated
December 21, 2017
Record last verified: 2017-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- December 2017 to December 2018
- Access Criteria
- public
Ultrasound for comparison of Gastric volume in pregnants undergoing Elective Lower Segment Cesarean Section and non-pregnant females undergoing elective surgeries.