Gastric Emptying During the Labour

Healthy Volunteers Clinical Trial

— VGObstetric  

Official title:

Effect of Labour on the Gastric Emptying of a Light Meal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03490682
• Other study ID #: 69HCL17_0863
• Secondary ID: 2017-A03605-48
• Status: Completed
• Phase: N/A
• Start date: May 17, 2018
• Est. completion date: November 11, 2021

Study information

• Verified date: November 2021
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: November 11, 2021
• Est. primary completion date: November 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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
• Delivery
• Patient admission for therapeutic interruption of the pregnancy

Related Conditions & MeSH terms

• Healthy Volunteers
• Parturition
• Pregnancy

Intervention

Other:
• Ultrasound assessment of gastric emptying of a flavoured yoghourt.
Each participant will be placed on a table, in the semi-recumbent position with elevation of the head at 45° and a first ultrasound examination will be performed. After that, the participant will be invited to eat a test meal (flavoured yoghurt) in 5 minutes. An ultrasound examination of the antrum allowing measurement of the antral area will be performed at 15, 60, 90 and 120 minutes after the end of the ingestion of the test meal. The participant must stay in the semi-recumbent position during the total duration of the study. The non-invasive ultrasound measurement, of the antral cross-sectional area is performed using a Sonosite ultrasound equiped with a 2 -5.5MHz probe. The diameters (longitudinal D1 and anteroposterior D2) of the antrum are measured in the sagittal plane passing by the abdominal aorta and the left lobe of the liver. The value of the antral cross-sectional area is given by the formula : Antral area = p x D1 x D2 / 4.

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	determination of the rate of gastric emptying of a light meal in the 3 groups of women	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	15 min after the ingestion of a flavoured yoghurt
Primary	determination of the rate of gastric emptying of a light meal in the 3 groups of women	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	90 min after the ingestion of a flavoured yoghurt
Secondary	Comparison of the rate of gastric emptying between the Control group and the Pregnancy group	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	15 min after the ingestion of a flavoured yoghurt
Secondary	Comparison of the rate of gastric emptying between the Control group and the Pregnancy group	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	90 min after the ingestion of a flavoured yoghurt
Secondary	Calculation of the sonographic rate of gastric emptying in the three groups of women.	In each group, the rate of gastric emptying will be calculated using the following formula : Rate = [(Antral area at 60 min / Antral area at 15 min)-1] x 100	15 min after the ingestion of a flavoured yoghurt
Secondary	Calculation of the sonographic rate of gastric emptying in the three groups of women.	In each group, the rate of gastric emptying will be calculated using the following formula : Rate = [(Antral area at 60 min / Antral area at 15 min)-1] x 100	60 min after the ingestion of a flavoured yoghurt
Secondary	The rate of women having an empty stomach after the ingestion of the test meal in each group.	Empty stomach will be defined by the lack of ultrasound visualization of any content in the semirecumbent position with antral area = 505 mm² in groups Parturient and Pregnancy, and by the lack of visualization of any content with antral area = 340 mm² in the Control group, 90 and 120 min after ingestion of the test meal.	90 min
Secondary	The rate of women having an empty stomach after the ingestion of the test meal in each group.	Empty stomach will be defined by the lack of ultrasound visualization of any content in the semirecumbent position with antral area = 505 mm² in groups Parturient and Pregnancy, and by the lack of visualization of any content with antral area = 340 mm² in the Control group, 90 and 120 min after ingestion of the test meal.	120 min
Secondary	Comparison of the rate of gastric emptying between the Analgesia group and the Parturient group	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	15 min after the ingestion of a flavoured yoghurt
Secondary	Comparison of the rate of gastric emptying between the Analgesia group and the Parturient group	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	90 min after the ingestion of a flavoured yoghurt