Gastric Emptying During the Labour (VGObstetric)

August 27, 2025 updated by: Hospices Civils de Lyon

Effect of Labour on the Gastric Emptying of a Light Meal

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69500
        • Hospices Civils de Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 36 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
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 = π x D1 x D2 / 4.
Active Comparator: 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.
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 = π x D1 x D2 / 4.
Experimental: 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.
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 = π x D1 x D2 / 4.
Experimental: 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.
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 = π x D1 x D2 / 4.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
determination of the rate of gastric emptying of a light meal in the 3 groups of women
Time Frame: 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
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
Time Frame: 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
90 min after the ingestion of a flavoured yoghurt

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Comparison of the rate of gastric emptying between the Control group and the Pregnancy group
Time Frame: 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
15 min after the ingestion of a flavoured yoghurt
Comparison of the rate of gastric emptying between the Control group and the Pregnancy group
Time Frame: 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
90 min after the ingestion of a flavoured yoghurt
Calculation of the sonographic rate of gastric emptying in the three groups of women.
Time Frame: 15 min after the ingestion of a flavoured yoghurt
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
Calculation of the sonographic rate of gastric emptying in the three groups of women.
Time Frame: 60 min after the ingestion of a flavoured yoghurt
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
The rate of women having an empty stomach after the ingestion of the test meal in each group.
Time Frame: 90 min
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
The rate of women having an empty stomach after the ingestion of the test meal in each group.
Time Frame: 120 min
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
Comparison of the rate of gastric emptying between the Analgesia group and the Parturient group
Time Frame: 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
15 min after the ingestion of a flavoured yoghurt
Comparison of the rate of gastric emptying between the Analgesia group and the Parturient group
Time Frame: 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
90 min after the ingestion of a flavoured yoghurt

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lionel BOUVET, MD, Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 17, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 11, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 11, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 69HCL17_0863
  • 2017-A03605-48 (Other Identifier: ID-RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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