Gastric Emptying of Water in Obese Term Pregnant Women

NCT ID: NCT04116749

Last Updated: 2022-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-27

Study Completion Date

2021-08-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnancy Related

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Non-obese women

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

Water

Intervention Type OTHER

Drink water freely until 2 hours before anesthesia.

Obese women

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

Water

Intervention Type OTHER

Drink water freely until 2 hours before anesthesia.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Water

Drink water freely until 2 hours before anesthesia.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kangbuk Samsung Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Eunah Cho, MD

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Eunah Cho, MD

Role: PRINCIPAL_INVESTIGATOR

KangbukSamsung Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kangbuk Samsung Hospital

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KBSMC 2019-08-039

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.