PregnancyNCT07482098
Gastric Ultrasound After Clear Fluid Intake in Diabetic and Non-Diabetic Pregnant Women
A study testing Oral water intake in people with Pregnancy and Gestational Diabetes Mellitus (GDM), run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Pulmonary aspiration of gastric contents during anesthesia is a serious perioperative complication associated with significant morbidity and mortality. Pregnant women are at increased risk of aspiration because of physiological changes such as delayed gastric emptying and increased intra-abdominal pressure. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pregnancy, Gestational Diabetes Mellitus (GDM)
- What is being tested?
- Oral water intake
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to 29 Jul 2026
- Phase
- Interventional
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women aged 18-40 years
- Scheduled for elective cesarean delivery
- ASA physical status II or III
- Patients who provide written informed consent
- Singleton pregnancy
- No contraindication to regional anesthesia
- Compliance with standard preoperative fasting requirements
Who cannot join
- Active labor
- Refusal to participate in the study
- Contraindication to regional anesthesia
- Previously diagnosed diabetic gastroparesis
- Pregestational diabetes mellitus (type 1 or type 2)
- History of upper gastrointestinal disease or gastroesophageal reflux disease
Show all 12Show fewer
- History of esophageal, gastric, or upper abdominal surgery
- Anatomical abnormalities of the upper gastrointestinal tract
- ASA physical status IV or higher
- Inability to adequately visualize the gastric antrum by ultrasonography
- Pre-existing neurological disease
- Infection at the spinal puncture site
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Ankara, 06800
About this study
Official title: Effect of Preoperative Clear Fluid Intake on Gastric Volume in Diabetic and Non-Diabetic Pregnant Women Assessed by Gastric Ultrasonography
Pulmonary aspiration of gastric contents during anesthesia is a serious perioperative complication associated with significant morbidity and mortality. Pregnant women are at increased risk of aspiration because of physiological changes such as delayed gastric emptying and increased intra-abdominal pressure. In addition, gestational diabetes mellitus (GDM) may affect gastric motility and gastric emptying.
Current fasting guidelines allow the intake of clear fluids up to two hours before anesthesia. However, the effect of preoperative oral clear fluid intake on gastric volume in pregnant women with GDM remains unclear.
Read more
This prospective interventional study compares gastric volume measured by gastric ultrasonography in term pregnant women with and without gestational diabetes mellitus (GDM) undergoing elective cesarean delivery. Participants receive 200 mL of oral water after baseline gastric ultrasonography. Gastric ultrasonography is performed before water intake (T1), immediately after completion of water intake (T2), and two hours after water intake immediately before anesthesia (T3) to evaluate gastric volume and gastric content.
The study aims to improve the assessment of gastric volume and perioperative fasting in pregnant women, particularly those with gestational diabetes mellitus.
Read the detailed description
Pulmonary aspiration of gastric contents is one of the most feared complications of obstetric anesthesia and may lead to significant morbidity and mortality. Pregnancy is associated with physiological changes including increased intra-abdominal pressure, gastroesophageal reflux, and alterations in gastric emptying, which may increase perioperative aspiration risk. Gestational diabetes mellitus (GDM) may further affect gastric motility and gastric emptying.
Preoperative fasting guidelines from major anesthesia societies allow the intake of clear fluids up to two hours before anesthesia. However, the effect of preoperative oral clear fluid intake on gastric volume in pregnant women with gestational diabetes mellitus remains unclear.
This single-center prospective interventional study evaluates term pregnant women scheduled for elective cesarean delivery. Participants are included in two groups according to the presence or absence of gestational diabetes mellitus. The GDM group includes women with gestational diabetes mellitus managed with diet or insulin during pregnancy, while the control group includes pregnant women without GDM.
After standard preoperative fasting, baseline gastric ultrasonography is performed immediately before oral fluid intake (T1). Participants then consume 200 mL of room-temperature drinking water orally. Gastric ultrasonography is repeated immediately after completion of water intake (T2) and two hours after water intake, immediately before anesthesia (T3).
Gastric ultrasonography is performed in the semi-recumbent and right lateral decubitus positions. The gastric antrum is identified using anatomical landmarks including the left lobe of the liver, pancreas, aorta, and inferior vena cava. The gastric antral cross-sectional area is calculated using the formula CSA = (D1 × D2 × π) / 4.
Gastric volume is estimated using the Roukhomovsky equation. Gastric contents are also qualitatively assessed using the three-grade Perlas grading system (Grade 0, 1, or 2).
Gastric volume is standardized to body weight in mL/kg. A standardized gastric volume greater than 1.5 mL/kg is classified as exceeding the high gastric volume threshold. This threshold is used as an ultrasonographic indicator of high gastric volume rather than as a direct threshold for pulmonary aspiration.
The primary objective is to compare the pattern of gastric volume change across the three predefined time points between pregnant women with GDM and those without GDM. Secondary assessments include qualitative evaluation of gastric contents using the Perlas grading system and the proportion of participants exceeding the high gastric volume threshold.
- Conditions
- Pregnancy, Gestational Diabetes Mellitus (GDM)
- Being tested
- Oral water intake
- Keywords
- Gastric Ultrasound, Cesarean Delivery, Preoperative Fasting, Gastric Volume, Pregnant Women, high gastric volume, Gestational Diabetes Mellitus
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral water intakeOther
Participants consume 200 mL of room-temperature drinking water orally immediately after the baseline gastric ultrasonography assessment (T1). Gastric ultrasonography is then repeated immediately after completion of water intake (T2) and 2 hours after water intake (T3).
| Study group | Role | What they receive |
|---|---|---|
| Gestational Diabetes Mellitus (GDM) Group | Experimental | Term pregnant women with gestational diabetes mellitus managed with diet or insulin during pregnancy. Participants receive 200 mL of oral water after baseline gastric ultrasonography and undergo gastric ultrasonography at three predefined time points: before water intake (T1), immediately after water intake (T2), and 2 hours after water intake (T3). Receives: Other: Oral water intake |
| Control Group | Experimental | Term pregnant women without gestational diabetes mellitus. Participants receive 200 mL of oral water after baseline gastric ultrasonography and undergo gastric ultrasonography at three predefined time points: before water intake (T1), immediately after water intake (T2), and 2 hours after water intake (T3). Receives: Other: Oral water intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric Volume Across Three Time Points
Gastric volume (mL) will be calculated from gastric antral cross-sectional area measurements obtained by ultrasonography using the Roukhomovsky equation. Gastric volume will be assessed at three predefined time points in women with gestational diabetes mellitus and women without gestational diabetes mellitus. The primary outcome is the difference in the pattern of gastric volume change over time between the two groups.
Measured: T1: after standard preoperative fasting, immediately before intake of 200 mL water; T2: immediately after completion of 200 mL water intake; T3: 2 hours after water intake, immediately before anesthesia.
Secondary outcomes (2)
Qualitative Assessment of Gastric Contents Using the Perlas Grading System
Gastric contents will be qualitatively assessed using the three-grade Perlas grading system (Grade 0, 1, or 2) based on ultrasonographic examination in the semi-recumbent and right lateral decubitus positions. The distribution of Perlas grades will be compared between groups and across the three measurement time points.
Measured: T1: before 200 mL water intake; T2: immediately after 200 mL water intake; T3: 2 hours after water intake.
Proportion of Participants Exceeding the High Gastric Volume Threshold (>1.5 mL/kg)
Gastric volume will be standardized to body weight (mL/kg). A standardized gastric volume >1.5 mL/kg will be classified as exceeding the high gastric volume threshold. This threshold is used as an ultrasonographic classification of high-volume gastric contents and is not considered a direct threshold for pulmonary aspiration. The proportion of participants exceeding this threshold will be compared between groups and across time points.
Measured: T1: before 200 mL water intake; T2: immediately after 200 mL water intake; T3: 2 hours after water intake.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start1 Dec 2025
- Primary completion29 Jul 2026
- Study completion29 Jul 2026
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants are enrolled into two parallel groups based on the presence or absence of gestational diabetes mellitus. All participants receive 200 mL of oral water and undergo gastric ultrasonography at predefined time points.
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Uyar Türkyılmaz, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07482098
- Sponsor's protocol ID
- IDGASTRICUSG2025
- Status last verified
- Oct 2026
- First submitted
- 16 Mar 2026
- Last updated
- 15 Oct 2026
- 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 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Clear Fluid Intake on Gastric Volume in Diabetic and Non-Diabetic Pregnant Women Assessed by Gastric Ultrasonography
- ClinicalTrials.gov ID
- NCT07482098
- Acronym / sponsor ID
- IDGASTRICUSG2025
- Conditions
- Pregnancy, Gestational Diabetes Mellitus (GDM)
- Keywords
- Gastric Ultrasound, Cesarean Delivery, Preoperative Fasting, Gastric Volume, Pregnant Women, high gastric volume, Gestational Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 29 Jul 2026 (actual)
- Study completion
- 29 Jul 2026 (actual)
- First posted
- 19 Mar 2026 (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.
Pulmonary aspiration of gastric contents during anesthesia is a serious perioperative complication associated with significant morbidity and mortality. Pregnant women are at increased risk of aspiration because of physiological changes such as delayed gastric emptying and increased intra-abdominal pressure. In addition, gestational diabetes mellitus (GDM) may affect gastric motility and gastric emptying.
Current fasting guidelines allow the intake of clear fluids up to two hours before anesthesia. However, the effect of preoperative oral clear fluid intake on gastric volume in pregnant women with GDM remains unclear.
This prospective interventional study compares gastric volume measured by gastric ultrasonography in term pregnant women with and without gestational diabetes mellitus (GDM) undergoing elective cesarean delivery. Participants receive 200 mL of oral water after baseline gastric ultrasonography. Gastric ultrasonography is performed before water intake (T1), immediately after completion of water intake (T2), and two hours after water intake immediately before anesthesia (T3) to evaluate gastric volume and gastric content.
The study aims to improve the assessment of gastric volume and perioperative fasting in pregnant women, particularly those with gestational diabetes mellitus.
Detailed description
Pulmonary aspiration of gastric contents is one of the most feared complications of obstetric anesthesia and may lead to significant morbidity and mortality. Pregnancy is associated with physiological changes including increased intra-abdominal pressure, gastroesophageal reflux, and alterations in gastric emptying, which may increase perioperative aspiration risk. Gestational diabetes mellitus (GDM) may further affect gastric motility and gastric emptying.
Preoperative fasting guidelines from major anesthesia societies allow the intake of clear fluids up to two hours before anesthesia. However, the effect of preoperative oral clear fluid intake on gastric volume in pregnant women with gestational diabetes mellitus remains unclear.
This single-center prospective interventional study evaluates term pregnant women scheduled for elective cesarean delivery. Participants are included in two groups according to the presence or absence of gestational diabetes mellitus. The GDM group includes women with gestational diabetes mellitus managed with diet or insulin during pregnancy, while the control group includes pregnant women without GDM.
After standard preoperative fasting, baseline gastric ultrasonography is performed immediately before oral fluid intake (T1). Participants then consume 200 mL of room-temperature drinking water orally. Gastric ultrasonography is repeated immediately after completion of water intake (T2) and two hours after water intake, immediately before anesthesia (T3).
Gastric ultrasonography is performed in the semi-recumbent and right lateral decubitus positions. The gastric antrum is identified using anatomical landmarks including the left lobe of the liver, pancreas, aorta, and inferior vena cava. The gastric antral cross-sectional area is calculated using the formula CSA = (D1 × D2 × π) / 4.
Gastric volume is estimated using the Roukhomovsky equation. Gastric contents are also qualitatively assessed using the three-grade Perlas grading system (Grade 0, 1, or 2).
Gastric volume is standardized to body weight in mL/kg. A standardized gastric volume greater than 1.5 mL/kg is classified as exceeding the high gastric volume threshold. This threshold is used as an ultrasonographic indicator of high gastric volume rather than as a direct threshold for pulmonary aspiration.
The primary objective is to compare the pattern of gastric volume change across the three predefined time points between pregnant women with GDM and those without GDM. Secondary assessments include qualitative evaluation of gastric contents using the Perlas grading system and the proportion of participants exceeding the high gastric volume threshold.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are enrolled into two parallel groups based on the presence or absence of gestational diabetes mellitus. All participants receive 200 mL of oral water and undergo gastric ultrasonography at predefined time points.
| Arm | Type | Receives |
|---|---|---|
| Gestational Diabetes Mellitus (GDM) Group | Experimental | Other: Oral water intakeTerm pregnant women with gestational diabetes mellitus managed with diet or insulin during pregnancy. Participants receive 200 mL of oral water after baseline gastric ultrasonography and undergo gastric ultrasonography at three predefined time points: before water intake (T1), immediately after water intake (T2), and 2 hours after water intake (T3). |
| Control Group | Experimental | Other: Oral water intakeTerm pregnant women without gestational diabetes mellitus. Participants receive 200 mL of oral water after baseline gastric ultrasonography and undergo gastric ultrasonography at three predefined time points: before water intake (T1), immediately after water intake (T2), and 2 hours after water intake (T3). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Pregnant women aged 18-40 years
- Scheduled for elective cesarean delivery
- ASA physical status II or III
- Patients who provide written informed consent
- Singleton pregnancy
Key exclusion criteria (12 listed)
- Active labor
- Refusal to participate in the study
- Contraindication to regional anesthesia
- Previously diagnosed diabetic gastroparesis
- Pregestational diabetes mellitus (type 1 or type 2)
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 |
|---|---|---|
| Oral water intakeParticipants consume 200 mL of room-temperature drinking water orally immediately after the baseline gastric ultrasonography assessment (T1). Gastric ultrasonography is then repeated immediately after completion of water intake (T2) and 2 hours after water intake (T3). | Other | Control Group, Gestational Diabetes Mellitus (GDM) Group |
Primary outcome
Gastric Volume Across Three Time Points
Time frame: T1: after standard preoperative fasting, immediately before intake of 200 mL water; T2: immediately after completion of 200 mL water intake; T3: 2 hours after water intake, immediately before anesthesia.
Gastric volume (mL) will be calculated from gastric antral cross-sectional area measurements obtained by ultrasonography using the Roukhomovsky equation. Gastric volume will be assessed at three predefined time points in women with gestational diabetes mellitus and women without gestational diabetes mellitus. The primary outcome is the difference in the pattern of gastric volume change over time between the two groups.
2 secondary outcomes
Qualitative Assessment of Gastric Contents Using the Perlas Grading System
Time frame: T1: before 200 mL water intake; T2: immediately after 200 mL water intake; T3: 2 hours after water intake.
Proportion of Participants Exceeding the High Gastric Volume Threshold (>1.5 mL/kg)
Time frame: T1: before 200 mL water intake; T2: immediately after 200 mL water intake; T3: 2 hours after water intake.
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 15 Oct 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral water intake in people with Pregnancy and Gestational Diabetes Mellitus (GDM), run by Ankara City Hospital Bilkent at 1 site 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 7 inclusion and 12 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 15 Oct 2026. 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 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 Volume Across Three Time Points (time frame: T1: after standard preoperative fasting, immediately before intake of 200 mL water; T2: immediately after completion of 200 mL water intake; T3: 2 hours after water intake, immediately before anesthesia.). 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 15 Oct 2026.