Rate of Gastric Emptying in Term Parturients Undergoing Elective Cesarean Section

Pregnancy Clinical Trial

Official title:

Rate of Gastric Emptying in Term Parturients Undergoing Elective Cesarean Section

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03800251
• Other study ID #: 8-2018
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2018
• Est. completion date: March 2019

Study information

• Verified date: January 2019
• Source: Coombe Women and Infants University Hospital
• Contact: Petar Popivanov
• Phone: +353 (01) 4085662
• Email: ppopivanov[@]coombe.ie
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Emptying
• Pregnancy

Intervention

Dietary Supplement:
• Nutricia PreOp - a clear, non-carbonated, lemon flavoured, carbohydrate drink that provides 0.5kcal/ml
Fasting parturients at term, admitted for elective cesarean section and consent to partake in the study, will be given the intervention drink

Locations

Country	Name	City	State
Ireland	Coombe Women and Infants University Hospital	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
Coombe Women and Infants University Hospital

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time interval required to return to the fasting grade.	The stomach will be scanned and graded (Perlas grade 0-2) every 15 minutes based on the presence or absence of clear fluid in supine and right lateral decubitus position at 45 degrees elevation of the upper body, after consumption of 400 ml clear carbohydrate drink (Nutricia PreOp).	2 hours
Secondary	Number of participants with grade 0, 1 and 2 in fasting term parturients attending for elective cesarean section	Initial "fasting" scan will be performed in all patients	10 minutes
Secondary	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	Sequential ultrasound scans will be performed at 15 min intervals for 2 hours.	2 hours
Secondary	Antral cross sectional area at 2 hours	Ultrasound measurement of antral cross sectional area will be performed at 2 hours after consumption of 400 ml clear carbohydrate drink (Nutricia PreOp).	2 hours