Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-31 @ 3:02 PM
Study NCT ID:
NCT03800251
Status:
UNKNOWN
Last Update Posted:
2019-01-11
First Post:
2019-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rate of Gastric Emptying in Term Parturients Undergoing Elective Cesarean Section
Sponsor:
Coombe Women and Infants University Hospital
Organization:
Study Overview
Official Title:
Rate of Gastric Emptying in Term Parturients Undergoing Elective Cesarean Section
Status:
UNKNOWN
Status Verified Date:
2019-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the study is to use sequential ultrasound evaluation of the gastric volume to determine how long it takes for the stomach of a fasting pregnant woman at term, admitted for elective cesarean section, to empty after ingesting a 400ml carbohydrate drink (Nutricia preOp).
Detailed Description:
Recent research suggests that attention to nutrition before operation leads to a speedier recovery through moderating the metabolic responses to surgery, improving well-being, decreasing post-operative insulin resistance and attenuation loss of lean body mass. On other hand there are fasting guidelines in place to prevent from pulmonary aspiration. The current fasting guidelines of 2hrs for clear fluids come from some small studies performed in healthy non-pregnant adults and consensus agreement.
The aim of the study is to use sequential ultrasound evaluation of the gastric volume to determine how long it takes for the stomach of a fasting pregnant woman at term, admitted for elective cesarean section, to empty after ingesting a 400ml carbohydrate drink (Nutricia preOp - a clear, non-carbonated, lemon flavoured, carbohydrate drink that provides 0.5kcal/ml).
Patients who are fasting according to the current guidelines and agree to partake in the study will, on the day of their elective LSCS, be given a 400ml carbohydrate drink at least 2hours before their scheduled theatre time. Patients will then have their gastric volume assessed at 15minutes intervals for 2 hours to determine how long it takes for the ingested fluid to leave the stomach. The results of the study will give us more information regarding gastric emptying in the investigator's patient population and may lead to reduced fasting times, increasing patient comfort and improving the patient experience.
The aim of the study is to use sequential ultrasound evaluation of the gastric volume to determine how long it takes for the stomach of a fasting pregnant woman at term, admitted for elective cesarean section, to empty after ingesting a 400ml carbohydrate drink (Nutricia preOp - a clear, non-carbonated, lemon flavoured, carbohydrate drink that provides 0.5kcal/ml).
Patients who are fasting according to the current guidelines and agree to partake in the study will, on the day of their elective LSCS, be given a 400ml carbohydrate drink at least 2hours before their scheduled theatre time. Patients will then have their gastric volume assessed at 15minutes intervals for 2 hours to determine how long it takes for the ingested fluid to leave the stomach. The results of the study will give us more information regarding gastric emptying in the investigator's patient population and may lead to reduced fasting times, increasing patient comfort and improving the patient experience.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: