PregnancyNCT06493110
Gastric Ultrasound in Term Pregnants
An observational study of Pregnancy and Diabetes, run by Kahramanmaras Sutcu Imam University at 2 sites in Turkey (Türkiye).
Trial summary
In this study, the investigators aimed to evaluate the gastric antrum with ultrasound and compare gastric volumes in diabetic and non-diabetic pregnant women in the standard fasting state before surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- What is being tested?
- Gastric ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 12 Mar 2024to 12 Jul 2024
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: This cohort comprised 30 diabetic and 30 non-diabetic individuals. The included participants were mentally healthy, aged 18 and above, classified as ASA II-III according to the American Society of Anesthesiologists, and had a gestational age of 36 weeks or more.
Who may be able to join
- Patients with good mental status
- Pregnant patients aged ≥18 years
- Patients in ASA II-III group
- Patients complying with preoperative fasting instructions (at least 6 hours for solids, at least 2 hours for clear liquids)
- Term pregnant women (gestational age ≥ 36 weeks)
- 50-120kg weight
- 150cm height or taller
- Written informed consent
Who cannot join
- Taking any medication known to accelerate or delay gastric emptying, including (but not limited to) opioid-containing medications and antacids.
- Gastroesophageal reflux, abnormal anatomy of the upper gastrointestinal tract, previous surgical procedures for the esophagus or upper abdomen, etc. any stomach complaints
- Pregnant women with term labor or obstetric emergency
- Twin pregnancy -
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
KahramanmarasSIU
Kahramanmaraş, 46100
Kahramanmaraş Sutcu Imam University
Kahramanmaraş, 46100
About this study
Official title: Comparison of Gastric Volumes With Ultrasound in Diabetic and Non-diabetic Term Pregnant Women Before Elective Cesarean Section
In this study, the investigators aimed to evaluate the gastric antrum with ultrasound and compare gastric volumes in diabetic and non-diabetic pregnant women in the standard fasting state before surgery. The primary aim was qualitative assessment, while secondary objectives included quantitative assessment, comparing gastric volume, aspiration risk, and the effect of preoperative anxiety on stomach contents.
Read the detailed description
Food residues in the stomach of patients scheduled for surgery are a major risk factor for pulmonary aspiration, leading to significant morbidity and mortality. This risk is particularly critical in pregnant women who may require surgery without proper fasting. National guidelines recommend fasting for 6 hours for solid foods, 4 hours for breast milk, and 2 hours for clear liquids. These guidelines apply equally to adults and children. Pregnant patients scheduled for elective surgery follow the same fasting rules as non-pregnant patients.
Gastroparesis, defined as delayed gastric emptying without mechanical obstruction, affects 30-50% of diabetic (DM) patients. Ultrasound measurement of the gastric antral area can help identify whether the stomach is full in symptomatic patients. Gastric ultrasound is a valuable tool for assessing aspiration risk in pregnant women, especially during emergency surgeries, and has shown promise in fasting non-pregnant patients scheduled for elective surgery.
In this study, the investigators aimed to evaluate the gastric antrum using ultrasound and compare gastric volumes in diabetic and non-diabetic pregnant women in a standard fasting state before surgery. The primary goal was qualitative assessment, with secondary objectives including quantitative assessment, comparing gastric volume, aspiration risk, and the effect of preoperative anxiety on stomach contents.
- Being tested
- Gastric ultrasound
- Keywords
- Gastric ultrasound, Term pregnant, Preoperative fasting
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric ultrasoundProcedure or surgery
To compare gastric volumes in standard fasting state before surgery in diabetic and non-diabetic pregnant women by evaluating the gastric antrum with ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| diabetic term pregnant | 1. Patients with good mental status
2. Pregnant patients aged ≥18 years
3. Patients in ASA II-III group
4. Patients complying with preoperative fasting instructions (at least 6 hours for solids, at least 2 hours for clear liquids)
5. Term pregnant women (gestational age ≥ 36 weeks)
6. 50-120kg weight
7. 150cm height or taller
8. Have written informed consent Receives: Procedure: Gastric ultrasound | |
| non-diabetic term pregnant | 1. Patients with good mental status
2. Pregnant patients aged ≥18 years
3. Patients in ASA II-III group
4. Patients complying with preoperative fasting instructions (at least 6 hours for solids, at least 2 hours for clear liquids)
5. Term pregnant women (gestational age ≥ 36 weeks)
6. 50-120kg weight
7. 150cm height or taller
8. Have written informed consent Receives: Procedure: Gastric ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric Antrum Quality
Qualitative evaluation of the gastric antrum using ultrasound: For the qualitative evaluation of the gastric antrum, we used a grading scale where the gastric antrum is classified as Grade 0, 1, or 2. The grading criteria are as follows:
Grade 0: The stomach appears empty in both supine and right lateral decubitus positions.
Grade 1: The stomach appears empty in the supine position but shows clear fluid in the right lateral decubitus position.
Grade 2: Clear fluid is seen in the stomach in both supine and right lateral decubitus positions.
Measured: 12 months
Secondary outcomes (3)
Gastric Volume
Quantitative measurement of gastric volume in milliliters.
Measured: 12 months
Aspiration Risk
Number of participants with a high aspiration risk based on gastric volume.
Measured: 12 months
Preoperative Anxiety Effect
Measurement of stomach content volume related to preoperative anxiety levels.
Measured: 12 moths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start12 Mar 2024
- Primary completion12 Jul 2024
- Study completion12 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feyza Calisir, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06493110
- Sponsor's protocol ID
- 2022/26-12
- Status last verified
- Oct 2024
- First submitted
- 22 Mar 2024
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Gastric Volumes With Ultrasound in Diabetic and Non-diabetic Term Pregnant Women Before Elective Cesarean Section
- ClinicalTrials.gov ID
- NCT06493110
- Acronym / sponsor ID
- 2022/26-12
- Keywords
- Gastric ultrasound, Term pregnant, Preoperative fasting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 12 Jul 2024 (actual)
- Study completion
- 12 Jul 2024 (actual)
- First posted
- 9 Jul 2024 (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.
In this study, the investigators aimed to evaluate the gastric antrum with ultrasound and compare gastric volumes in diabetic and non-diabetic pregnant women in the standard fasting state before surgery. The primary aim was qualitative assessment, while secondary objectives included quantitative assessment, comparing gastric volume, aspiration risk, and the effect of preoperative anxiety on stomach contents.
Detailed description
Food residues in the stomach of patients scheduled for surgery are a major risk factor for pulmonary aspiration, leading to significant morbidity and mortality. This risk is particularly critical in pregnant women who may require surgery without proper fasting. National guidelines recommend fasting for 6 hours for solid foods, 4 hours for breast milk, and 2 hours for clear liquids. These guidelines apply equally to adults and children. Pregnant patients scheduled for elective surgery follow the same fasting rules as non-pregnant patients.
Gastroparesis, defined as delayed gastric emptying without mechanical obstruction, affects 30-50% of diabetic (DM) patients. Ultrasound measurement of the gastric antral area can help identify whether the stomach is full in symptomatic patients. Gastric ultrasound is a valuable tool for assessing aspiration risk in pregnant women, especially during emergency surgeries, and has shown promise in fasting non-pregnant patients scheduled for elective surgery.
In this study, the investigators aimed to evaluate the gastric antrum using ultrasound and compare gastric volumes in diabetic and non-diabetic pregnant women in a standard fasting state before surgery. The primary goal was qualitative assessment, with secondary objectives including quantitative assessment, comparing gastric volume, aspiration risk, and the effect of preoperative anxiety on stomach contents.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diabetic term pregnant | – | Procedure: Gastric ultrasound1. Patients with good mental status 2. Pregnant patients aged ≥18 years 3. Patients in ASA II-III group 4. Patients complying with preoperative fasting instructions (at least 6 hours for solids, at least 2 hours for clear liquids) 5. Term pregnant women (gestational age ≥ 36 weeks) 6. 50-120kg weight 7. 150cm height or taller 8. Have written informed consent |
| non-diabetic term pregnant | – | Procedure: Gastric ultrasound1. Patients with good mental status 2. Pregnant patients aged ≥18 years 3. Patients in ASA II-III group 4. Patients complying with preoperative fasting instructions (at least 6 hours for solids, at least 2 hours for clear liquids) 5. Term pregnant women (gestational age ≥ 36 weeks) 6. 50-120kg weight 7. 150cm height or taller 8. Have written informed consent |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This cohort comprised 30 diabetic and 30 non-diabetic individuals. The included participants were mentally healthy, aged 18 and above, classified as ASA II-III according to the American Society of Anesthesiologists, and had a gestational age of 36 weeks or more.
Key inclusion criteria (8 listed)
- Patients with good mental status
- Pregnant patients aged ≥18 years
- Patients in ASA II-III group
- Patients complying with preoperative fasting instructions (at least 6 hours for solids, at least 2 hours for clear liquids)
- Term pregnant women (gestational age ≥ 36 weeks)
Key exclusion criteria (4 listed)
- Taking any medication known to accelerate or delay gastric emptying, including (but not limited to) opioid-containing medications and antacids.
- Gastroesophageal reflux, abnormal anatomy of the upper gastrointestinal tract, previous surgical procedures for the esophagus or upper abdomen, etc. any stomach complaints
- Pregnant women with term labor or obstetric emergency
- Twin pregnancy -
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 |
|---|---|---|
| Gastric ultrasoundTo compare gastric volumes in standard fasting state before surgery in diabetic and non-diabetic pregnant women by evaluating the gastric antrum with ultrasound. | Procedure or surgery | diabetic term pregnant, non-diabetic term pregnant |
Primary outcome
Gastric Antrum Quality
Time frame: 12 months
Qualitative evaluation of the gastric antrum using ultrasound: For the qualitative evaluation of the gastric antrum, we used a grading scale where the gastric antrum is classified as Grade 0, 1, or 2. The grading criteria are as follows: Grade 0: The stomach appears empty in both supine and right lateral decubitus positions. Grade 1: The stomach appears empty in the supine position but shows clear fluid in the right lateral decubitus position. Grade 2: Clear fluid is seen in the stomach in both supine and right lateral decubitus positions.
3 secondary outcomes
Gastric Volume
Time frame: 12 months
Aspiration Risk
Time frame: 12 months
Preoperative Anxiety Effect
Time frame: 12 moths
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Pregnancy
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Diabetes, run by Kahramanmaras Sutcu Imam University at 2 sites in Turkey (Türkiye).
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 8 inclusion and 4 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: finished, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Antrum Quality (time frame: 12 months). 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 21 Oct 2024.