Comparison of Gastric Volumes With Ultrasound in Diabetic and Non-diabetic Term Pregnant Women Before Elective Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Gastric Antrum Quality
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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 -
结局指标
主要结局
Gastric Antrum Quality
时间窗: 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.
次要结局
- Preoperative Anxiety Effect(12 moths)
- Gastric Volume(12 months)
- Aspiration Risk(12 months)
研究者
Feyza Calisir
Assistant professor
Kahramanmaras Sutcu Imam University