Gastric Emptying of Water in Obese Term Pregnant Women

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04116749
• Other study ID #: KBSMC 2019-08-039
• Status: Terminated
• Start date: November 27, 2019
• Est. completion date: August 11, 2021

Study information

• Verified date: March 2022
• Source: Kangbuk Samsung Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: August 11, 2021
• Est. primary completion date: August 11, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

Other:
• Water
Drink water freely until 2 hours before anesthesia.

Locations

Country	Name	City	State
Korea, Republic of	Kangbuk Samsung Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kangbuk Samsung Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric antral cross-sectional area	Cross-sectional area of gastric antrum assessed by ultrasonography	2 hours after the time allowed to drink water.
Secondary	Preoperative anxiety	Preoperative anxiety is scored from 0 (never) to 10 (very much).	2 hours after the time allowed to drink water.
Secondary	Hunger score	Hunger score is scored from 0 (never) to 10 (very much).	2 hours after the time allowed to drink water.
Secondary	Thirst score	Thirst score is scored from 0 (never) to 10 (very much).	2 hours after the time allowed to drink water.