Clinical Trials Directory

Trials / Terminated

TerminatedNCT04116749

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
Phase
Study type
Observational
Enrollment
26 (actual)
Sponsor
Kangbuk Samsung Hospital · Academic / Other
Sex
Female
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERWaterDrink water freely until 2 hours before anesthesia.

Timeline

Start date
2019-11-27
Primary completion
2021-08-11
Completion
2021-08-11
First posted
2019-10-07
Last updated
2022-04-07

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT04116749. Inclusion in this directory is not an endorsement.