Gastric Ultrasound in Term Pregnants

Kahramanmaraş Sütçü İmam University (KSU)

Status: Completed

Conditions: Diabetes; Pregnancy

Treatments: Procedure: Gastric ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT06493110

2022/26-12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 -

Trial design

60 participants in 2 patient groups

diabetic term pregnant

Description:

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

Treatment:

Procedure: Gastric ultrasound

non-diabetic term pregnant

Description:

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

Treatment:

Procedure: Gastric ultrasound