Gastric Emptying of Water in Obese Term Pregnant Women

March 29, 2022 updated by: Eunah Cho, MD, Kangbuk Samsung Hospital

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Non-obese women
body mass index lower than 30 (kg/m^2) at term
Other: Water
Drink water freely until 2 hours before anesthesia.
Obese women
body mass index equal or greater than 30 (kg/m^2) at term
Other: Water
Drink water freely until 2 hours before anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 hours after the time allowed to drink water.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preoperative anxiety
Time Frame: 2 hours after the time allowed to drink water.
Preoperative anxiety is scored from 0 (never) to 10 (very much).
2 hours after the time allowed to drink water.
Hunger score
Time Frame: 2 hours after the time allowed to drink water.
Hunger score is scored from 0 (never) to 10 (very much).
2 hours after the time allowed to drink water.
Thirst score
Time Frame: 2 hours after the time allowed to drink water.
Thirst score is scored from 0 (never) to 10 (very much).
2 hours after the time allowed to drink water.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kangbuk Samsung Hospital

Investigators

  • Principal Investigator: Eunah Cho, MD, Kangbuksamsung Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2019

Primary Completion (Actual)

August 11, 2021

Study Completion (Actual)

August 11, 2021

Study Registration Dates

First Submitted

October 3, 2019

First Submitted That Met QC Criteria

October 4, 2019

First Posted (Actual)

October 7, 2019

Study Record Updates

Last Update Posted (Actual)

April 7, 2022

Last Update Submitted That Met QC Criteria

March 29, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • KBSMC 2019-08-039

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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