Gastric Emptying of Water in Obese Term Pregnant Women

NCT04116749 | Terminated DMC

• 1 other identifier: KBSMC 2019-08-039
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related

Outcome Measures

Primary Outcomes (1)

• Gastric antral cross-sectional area

  Cross-sectional area of gastric antrum assessed by ultrasonography

  2 hours after the time allowed to drink water.

Secondary Outcomes (3)

• Preoperative anxiety

  2 hours after the time allowed to drink water.

• Hunger score

  2 hours after the time allowed to drink water.

• Thirst score

  2 hours after the time allowed to drink water.

Study Arms (2)

Non-obese women

body mass index lower than 30 (kg/m\^2) at term

Other: Water

Obese women

body mass index equal or greater than 30 (kg/m\^2) at term

Other: Water

Interventions

Water OTHER

Drink water freely until 2 hours before anesthesia.

Non-obese women; Obese women

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Women undergoing elective cesarean section.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Non laboring, term (≥37 weeks) pregnant women uldergoing elective cesarean section, in our medical center.

You may qualify if:

• Non laboring, term (≥37 weeks) pregnant women
• Scheduled for elective cesarean section
• aged ≥ 18 years old
• American Society of Anesthesiology physical class 1-3

You may not qualify if:

• multigestational pregnancy
• diagnosed for delayed gastric emptying (GERD, gastrointestinal disease)
• diabetes

Sponsors & Collaborators

• Kangbuk Samsung Hospital: lead

Study Sites (1)

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Eunah Cho, MD

  KangbukSamsung Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 7, 2019
• Study Start: November 27, 2019
• Primary Completion: August 11, 2021
• Study Completion: August 11, 2021
• Last Updated: April 7, 2022

Record last verified: 2022-03

Locations

KR (1)