Clinical trial NCT06493110: Gastric Ultrasound in Term Pregnants
Official title: Comparison of Gastric Volumes With Ultrasound in Diabetic and Non-diabetic Term Pregnant Women Before Elective Cesarean Section
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Diabetes
Keywords: Gastric ultrasound
Term pregnant
Preoperative fasting
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

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. Written informed consent

Exclusion Criteria:

1. Taking any medication known to accelerate or delay gastric emptying, including (but not limited to) opioid-containing medications and antacids.
2. Gastroesophageal reflux, abnormal anatomy of the upper gastrointestinal tract, previous surgical procedures for the esophagus or upper abdomen, etc. any stomach complaints
3. Pregnant women with term labor or obstetric emergency
4. Twin pregnancy -

Primary outcomes:
measure: Gastric Antrum Quality
timeFrame: 12 months
Secondary outcomes:
measure: Gastric Volume
timeFrame: 12 months
measure: Aspiration Risk
timeFrame: 12 months
measure: Preoperative Anxiety Effect
timeFrame: 12 moths
Other outcomes:
Locations:
city: Kahramanmaraş
country: Turkey
facility: KahramanmarasSIU
city: Kahramanmaraş
country: Turkey
facility: Kahramanmaraş Sutcu Imam University
Study officials:
References: