Effect of Labour on the Gastric Emptying of a Light Meal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- determination of the rate of gastric emptying of a light meal in the 3 groups of women
研究概览
简要总结
Current recommendations permit the ingestion of all clear fluids (water, apple juice, black coffee..) during labour. However, regarding food during labour, the recommendations vary. British and European guidelines permit the ingestion of low-residue food during labour whilst guidelines from the United States prohibit having any solid food during labour. The reason for this variation in recommendations is the lack of data on gastric emptying during labour with a conservative approach adopted due to the fear of delayed gastric emptying increasing the risk of regurgitation and pulmonary aspiration in the case of general anaesthesia. This study aims, therefore, to evaluate if the gastric emptying of a light meal is slowed down during labour, using a validated, non-invasive ultrasound method, in four groups of women : Women in labour with epidural analgesia (Analgesia group), women in labor without any epidural analgesia (Parturient group), women in the third trimester of pregnancy (Pregnant group) and women who are not currently pregnant (Non-pregnant control group). The investigator propose the hypothesis that the gastric emptying of a light, solid meal is slowed by 30% during labour under epidural analgesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Informed consent must have been signed. The last consumption of solids will have taken place more than 6 hours before the start of the study, the last consumption of clear fluids will have taken place more than 1 hour before the start of the study, in the three groups.
- •Non-pregnant control group : adult females less than 40 years old with no significant medical history (American Society of Anesthesiologists ASA class 1)
- •Pregnant group : adult females less than 40 years old with no significant medical history (American Society of Anesthesiologists ASA class 1) in the third trimester of pregnancy (gestation greater than 32 weeks on the day of the study).
- •Analgesia group : adult females less than 40 years old with no significant medical history (American Society of Anesthesiologists ASA class 1, in labour in the delivery room, receiving effective epidural analgesia, having an empty stomach on the initial ultrasound examination, and authorised to ingest solid foods during labour (cervical dilatation strictly less than 8cm) according to local guidelines.
- •Parturient group : adult females less than 35 years old with no significant medical history (American Society of Anesthesiologists ASA class 1, in labour in the delivery room, no epidural analgesia, having an empty stomach on the initial ultrasound examination, and authorised to ingest solid foods during labour (cervical dilatation strictly less than 8cm) according to local guidelines
排除标准
- •Refusal to participate in this study
- •Patient unable to speak French
- •Oesophageal, duodenal or gastric medical or surgical history Pregnant group : Threatened premature labour, multiple pregnancy, pathological pregnancy
- •Analgesia and Parturient groups :
- •gestation less than 38 weeks
- •multiple pregnancy
- •All pathology of the pregnancy or complication during labour
- •Patient admission for therapeutic interruption of the pregnancy
研究组 & 干预措施
Non-pregnant control
adult females aged less than 40 years, not currently pregnant, without significant medical history (American Society of Anesthesiologists ASA 1), fasting for at least 6 hours for solids and 1 hour for clear fluids.
干预措施: Ultrasound assessment of gastric emptying of a flavoured yoghourt. (Other)
Pregnant control
adult females aged less than 40 years, pregnant in the third trimester (gestation greater than 32 weeks on the day of the study) according to dates and the calculation of term established at the start of the pregnancy by an obstetrician, without significant medical history (American Society of Anesthesiologists ASA 1), fasting for at least 6 hours for solids and I hour for clear fluids.
干预措施: Ultrasound assessment of gastric emptying of a flavoured yoghourt. (Other)
Analgesia
adult females aged less than 40 years, without significant medical history (American Society of Anesthesiologists ASA 1), in labour in the delivery suite, with a working epidural, having consumed solid food more than 6 hours before inclusion in the study and clear fluids more than 1 hour before inclusion in the study, and allowed to ingest solids during labour (cervical dilatation strictly less than 8cm) conforming to local protocols.
干预措施: Ultrasound assessment of gastric emptying of a flavoured yoghourt. (Other)
Parturient
adult females aged less than 35 years, without significant medical history (American Society of Anesthesiologists ASA 1), in labour in the delivery suite, without any epidural analgesia, having consumed solid food more than 6 hours before inclusion in the study and clear fluids more than 1 hour before inclusion in the study, and allowed to ingest solids during labour (cervical dilatation strictly less than 8cm) conforming to local protocols.
干预措施: Ultrasound assessment of gastric emptying of a flavoured yoghourt. (Other)
结局指标
主要结局
determination of the rate of gastric emptying of a light meal in the 3 groups of women
时间窗: 90 min after the ingestion of a flavoured yoghurt
The rate of gastric emptying will be calculated using the following formula : Rate = \[(Antral area at 90 min / Antral area at 15 min)-1\] x 100
determination of the rate of gastric emptying of a light meal in the 3 groups of women
时间窗: 15 min after the ingestion of a flavoured yoghurt
The rate of gastric emptying will be calculated using the following formula : Rate = \[(Antral area at 90 min / Antral area at 15 min)-1\] x 100
次要结局
- Comparison of the rate of gastric emptying between the Control group and the Pregnancy group(90 min after the ingestion of a flavoured yoghurt)
- Calculation of the sonographic rate of gastric emptying in the three groups of women.(60 min after the ingestion of a flavoured yoghurt)
- Comparison of the rate of gastric emptying between the Analgesia group and the Parturient group(90 min after the ingestion of a flavoured yoghurt)
- The rate of women having an empty stomach after the ingestion of the test meal in each group.(120 min)
- Comparison of the rate of gastric emptying between the Control group and the Pregnancy group(15 min after the ingestion of a flavoured yoghurt)
- Calculation of the sonographic rate of gastric emptying in the three groups of women.(15 min after the ingestion of a flavoured yoghurt)
- The rate of women having an empty stomach after the ingestion of the test meal in each group.(90 min)
- Comparison of the rate of gastric emptying between the Analgesia group and the Parturient group(15 min after the ingestion of a flavoured yoghurt)