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Gastric Emptying of Water in Obese Term Pregnant Women

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04116749
Enrollment
26
Registered
2019-10-07
Start date
2019-11-27
Completion date
2021-08-11
Last updated
2022-04-07

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

Conditions

Pregnancy Related

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.

Interventions

OTHERWater

Drink water freely until 2 hours before anesthesia.

Sponsors

Kangbuk Samsung Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years
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) * diabetes

Design outcomes

Primary

MeasureTime frameDescription
Gastric antral cross-sectional area2 hours after the time allowed to drink water.Cross-sectional area of gastric antrum assessed by ultrasonography

Secondary

MeasureTime frameDescription
Preoperative anxiety2 hours after the time allowed to drink water.Preoperative anxiety is scored from 0 (never) to 10 (very much).
Hunger score2 hours after the time allowed to drink water.Hunger score is scored from 0 (never) to 10 (very much).
Thirst score2 hours after the time allowed to drink water.Thirst score is scored from 0 (never) to 10 (very much).

Countries

South Korea

Outcome results

None listed

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