Gastric Emptying During the Labour

NCT03490682 | Completed

• 2 other identifiers: 69HCL17_08632017-A03605-48
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy; Healthy Volunteers; Parturition

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (8)

• Comparison of the rate of gastric emptying between the Control group and the Pregnancy group

  15 min after the ingestion of a flavoured yoghurt

• 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.

  15 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

• The rate of women having an empty stomach after the ingestion of the test meal in each group.

  90 min

Study Arms (4)

Non-pregnant control

ACTIVE COMPARATOR

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.

Other: Ultrasound assessment of gastric emptying of a flavoured yoghourt.

Pregnant control

ACTIVE COMPARATOR

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.

Other: Ultrasound assessment of gastric emptying of a flavoured yoghourt.

Analgesia

EXPERIMENTAL

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.

Other: Ultrasound assessment of gastric emptying of a flavoured yoghourt.

Parturient

EXPERIMENTAL

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.

Other: Ultrasound assessment of gastric emptying of a flavoured yoghourt.

Interventions

Ultrasound assessment of gastric emptying of a flavoured yoghourt. OTHER

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 = π x D1 x D2 / 4.

Analgesia; Non-pregnant control; Parturient; Pregnant control

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon

Bron, 69500, France

Location

Related Publications (1)

• Bouvet L, Schulz T, Piana F, Desgranges FP, Chassard D. Pregnancy and Labor Epidural Effects on Gastric Emptying: A Prospective Comparative Study. Anesthesiology. 2022 Apr 1;136(4):542-550. doi: 10.1097/ALN.0000000000004133.

  PMID: 35103759 BACKGROUND

Study Officials

• Lionel BOUVET, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2018
• First Posted: April 6, 2018
• Study Start: May 17, 2018
• Primary Completion: November 11, 2021
• Study Completion: November 11, 2021
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

FR (1)