Comparison of Gastric Emptying of Water in Obese vs. Non-obese Term Pregnant Women Undergoing Elective Cesarean Section
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Gastric antral cross-sectional area
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Gastric antral cross-sectional area
Time Frame: 2 hours after the time allowed to drink water.
Cross-sectional area of gastric antrum assessed by ultrasonography
Secondary Outcomes
- Hunger score(2 hours after the time allowed to drink water.)
- Preoperative anxiety(2 hours after the time allowed to drink water.)
- Thirst score(2 hours after the time allowed to drink water.)
Investigators
Eunah Cho, MD
Clinical Assistant Professor
Kangbuk Samsung Hospital