Clinical trial NCT03800251: Rate of Gastric Emptying in Term Parturients Undergoing Elective Cesarean Section
Official title: Rate of Gastric Emptying in Term Parturients Undergoing Elective Cesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Emptying
Pregnancy
Keywords: Gastric Emptying
Pregnancy
Elective Cesarean section
Fasting
Lead sponsor: Coombe Women and Infants University Hospital
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients who are fasting according to the guidelines and agree to partake in the study will, on the day of their elective LSCS, be given a 400ml carbohydrate drink at least 2hrs before their scheduled theatre time and will then have their gastric volume assessed at 15min intervals for 2hrs to determine how long it takes for the ingested fluid to leave the stomach.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Elective LSCS
* 18yrs
* gestation \>38 gestation weeks

Exclusion Criteria:

* Multiple pregnancy
* Previous upper GI surgery
* Known disorder of gastric emptying
* Hiatus Hernia
* BMI \>40
* Diabetes Mellitus, Gestational Diabetes

Primary outcomes:
measure: Time interval required to return to the fasting grade.
timeFrame: 2 hours
Secondary outcomes:
measure: Number of participants with grade 0, 1 and 2 in fasting term parturients attending for elective cesarean section
timeFrame: 10 minutes
measure: Time taken for the antral cross sectional area (measured by ultrasound) to reach <9.6 cm2 (suggested cut off value for ingested volumes < 1.5ml.kg-1) after ingesting 400 ml carbohydrate drink
timeFrame: 2 hours
measure: Antral cross sectional area at 2 hours
timeFrame: 2 hours
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Coombe Women and Infants University Hospital
Study officials:
References: