Pregnancy RelatedNCT04116749
Gastric Emptying of Water in Obese Term Pregnant Women
An observational study of Pregnancy Related, run by Kangbuk Samsung Hospital at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Water
- How many people
- 26 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Nov 2019to 11 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Non laboring, term (≥37 weeks) pregnant women uldergoing elective cesarean section, in our medical center.
Who may be able to join
- Non laboring, term (≥37 weeks) pregnant women
- Scheduled for elective cesarean section
- aged ≥ 18 years old
- American Society of Anesthesiology physical class 1-3
Who cannot join
- multigestational pregnancy
- diagnosed for delayed gastric emptying (GERD, gastrointestinal disease)
- diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Pregnancy Related
- Being tested
- Water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WaterOther
Drink water freely until 2 hours before anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Non-obese women | body mass index lower than 30 (kg/m^2) at term Receives: Other: Water | |
| Obese women | body mass index equal or greater than 30 (kg/m^2) at term Receives: Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric antral cross-sectional area
Cross-sectional area of gastric antrum assessed by ultrasonography
Measured: 2 hours after the time allowed to drink water.
Secondary outcomes (3)
Preoperative anxiety
Preoperative anxiety is scored from 0 (never) to 10 (very much).
Measured: 2 hours after the time allowed to drink water.
Hunger score
Hunger score is scored from 0 (never) to 10 (very much).
Measured: 2 hours after the time allowed to drink water.
Thirst score
Thirst score is scored from 0 (never) to 10 (very much).
Measured: 2 hours after the time allowed to drink water.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start27 Nov 2019
- Primary completion11 Aug 2021
- Study completion11 Aug 2021
Why it stopped: Unavailable to collect study participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kangbuk Samsung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eunah Cho, MD, Kangbuk Samsung Hospital
- Investigators
- Eunah Cho, MD, Principal investigator, KangbukSamsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04116749
- Sponsor's protocol ID
- KBSMC 2019-08-039
- Status last verified
- Mar 2022
- First submitted
- 3 Oct 2019
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Gastric Emptying of Water in Obese vs. Non-obese Term Pregnant Women Undergoing Elective Cesarean Section
- ClinicalTrials.gov ID
- NCT04116749
- Acronym / sponsor ID
- KBSMC 2019-08-039
- Conditions
- Pregnancy Related
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Unavailable to collect study participants.
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Kangbuk Samsung HospitalUniversity, hospital or other
- Study start
- 27 Nov 2019 (actual)
- Primary completion
- 11 Aug 2021 (actual)
- Study completion
- 11 Aug 2021 (actual)
- First posted
- 7 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-obese women | – | Other: Waterbody mass index lower than 30 (kg/m^2) at term |
| Obese women | – | Other: Waterbody mass index equal or greater than 30 (kg/m^2) at term |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non laboring, term (≥37 weeks) pregnant women uldergoing elective cesarean section, in our medical center.
Key inclusion criteria (4 listed)
- Non laboring, term (≥37 weeks) pregnant women
- Scheduled for elective cesarean section
- aged ≥ 18 years old
- American Society of Anesthesiology physical class 1-3
Key exclusion criteria (3 listed)
- multigestational pregnancy
- diagnosed for delayed gastric emptying (GERD, gastrointestinal disease)
- diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WaterDrink water freely until 2 hours before anesthesia. | Other | Non-obese women, Obese women |
Primary outcome
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
3 secondary outcomes
Preoperative anxiety
Time frame: 2 hours after the time allowed to drink water.
Hunger score
Time frame: 2 hours after the time allowed to drink water.
Thirst score
Time frame: 2 hours after the time allowed to drink water.
Results and safety
The study was stopped early (reason given: Unavailable to collect study participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eunah Cho, MD principal investigator
KangbukSamsung Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related, run by Kangbuk Samsung Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unavailable to collect study participants.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric antral cross-sectional area (time frame: 2 hours after the time allowed to drink water.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022; AzTrials last refreshed its copy on 8 Nov 2026.