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Rate of Gastric Emptying in Term Parturients Undergoing Elective Cesarean Section

Rate of Gastric Emptying in Term Parturients Undergoing Elective Cesarean Section

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03800251
Enrollment
40
Registered
2019-01-11
Start date
2018-06-06
Completion date
2019-03-31
Last updated
2019-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Emptying, Pregnancy

Keywords

Gastric Emptying, Pregnancy, Elective Cesarean section, Fasting

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.

Interventions

DIETARY_SUPPLEMENTNutricia 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

Sponsors

Coombe Women and Infants University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Time interval required to return to the fasting grade.2 hoursThe 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).

Secondary

MeasureTime frameDescription
Number of participants with grade 0, 1 and 2 in fasting term parturients attending for elective cesarean section10 minutesInitial fasting scan will be performed in all patients
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 drink2 hoursSequential ultrasound scans will be performed at 15 min intervals for 2 hours.
Antral cross sectional area at 2 hours2 hoursUltrasound measurement of antral cross sectional area will be performed at 2 hours after consumption of 400 ml clear carbohydrate drink (Nutricia PreOp).

Countries

Ireland

Contacts

Primary ContactPetar Popivanov
ppopivanov@coombe.ie+353 (01) 4085662
Backup ContactMichelle Walsh
michowalsh@gmail.com+353 (01) 4085662

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026