Gastric Emptying of Water in Obese Term Pregnant Women

Study Overview
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Brief Summary
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It has been believed that the risk of pulmonary aspiration in term pregnant women is increased, and should be considered that all term pregnant women to have full stomach. Recently, gastric ultrasound has been adopted as a useful tool for quantitative and qualitative assessment of stomach before anesthesia, and predict the risk of pulmonary aspiration. Although, both the obesity and pregnancy are known to be the risk of pulmonary aspiration, it is suggested in the American Society of Anesthesiology fasting guidelines, that the same fasting time should be applied in the obese and non-obese parturients. However, this was based on one study done in a small (10) numbers of volunteers. Therefore, the investigators aimed to compare the gastric antral cross-sectional area in both obese and non-obese term pregnant women, scheduled for elective cesarean section.

Detailed Description
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This study is a prospective, observational study. 42 term (≥37 weeks) pregnant, non-laboring adult women scheduled for cesarean delivery will be included in the study. They will be allowed to drink water freely, until 2 hours before the anesthesia. Gastric ultrasound will be performed in 21 non-obese women, and 21 obese women. The obesity is defined by the body mass index at term.

Official Title
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Comparison of Gastric Emptying of Water in Obese vs. Non-obese Term Pregnant Women Undergoing Elective Cesarean Section

Conditions
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Pregnancy Related

Intervention / Treatment
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* Other: Water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non laboring, term (≥37 weeks) pregnant women Scheduled for elective cesarean section aged ≥ 18 years old American Society of Anesthesiology physical class 1-3 Exclusion Criteria: multigestational pregnancy diagnosed for delayed gastric emptying (GERD, gastrointestinal disease) diabetes

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-obese women<br>body mass index lower than 30 (kg/m^2) at term | Other: Water<br>* Drink water freely until 2 hours before anesthesia.<br>|
| Obese women<br>body mass index equal or greater than 30 (kg/m^2) at term | Other: Water<br>* Drink water freely until 2 hours before anesthesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric antral cross-sectional area | Cross-sectional area of gastric antrum assessed by ultrasonography | 2 hours after the time allowed to drink water. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preoperative anxiety | Preoperative anxiety is scored from 0 (never) to 10 (very much). | 2 hours after the time allowed to drink water. | 
| Hunger score | Hunger score is scored from 0 (never) to 10 (very much). | 2 hours after the time allowed to drink water. | 
| Thirst score | Thirst score is scored from 0 (never) to 10 (very much). | 2 hours after the time allowed to drink water. |