PregnancyVGObstetricNCT03490682
Gastric Emptying During the Labour
A study testing Ultrasound assessment of gastric emptying of a flavoured yoghourt. in people with Pregnancy and Healthy Volunteers, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Healthy Volunteers, Parturition
- What is being tested?
- Ultrasound assessment of gastric emptying of a flavoured yoghourt.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- 17 May 2018to 11 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- All pathology of the pregnancy or complication during labour
- Delivery
- Patient admission for therapeutic interruption of the pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Pregnancy, Healthy Volunteers, Parturition
- Being tested
- Ultrasound assessment of gastric emptying of a flavoured yoghourt.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Ultrasound assessment of gastric emptying of a flavoured yoghourt. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
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
Measured: 15 min after the ingestion of a flavoured yoghurt
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
Measured: 90 min after the ingestion of a flavoured yoghurt
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
Measured: 15 min after the ingestion of a flavoured yoghurt
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
Measured: 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.
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.
Measured: 90 min
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.
Measured: 120 min
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
Measured: 15 min after the ingestion of a flavoured yoghurt
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
Measured: 90 min after the ingestion of a flavoured yoghurt
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start17 May 2018
- Primary completion11 Nov 2021
- Study completion11 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lionel BOUVET, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490682
- Sponsor's protocol ID
- 69HCL17_0863
- Other IDs
- 2017-A03605-48
- Acronym
- VGObstetric
- Status last verified
- Aug 2025
- First submitted
- 30 Mar 2018
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35103759
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Labour on the Gastric Emptying of a Light Meal
- ClinicalTrials.gov ID
- NCT03490682
- Acronym / sponsor ID
- VGObstetric / 69HCL17_0863
- Conditions
- Pregnancy, Healthy Volunteers, Parturition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 17 May 2018 (actual)
- Primary completion
- 11 Nov 2021 (actual)
- Study completion
- 11 Nov 2021 (actual)
- First posted
- 6 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-pregnant control | Active comparator | Other: Ultrasound assessment of gastric emptying of a flavoured yoghourt.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. |
| Pregnant control | Active comparator | Other: Ultrasound assessment of gastric emptying of a flavoured yoghourt.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. |
| Analgesia | Experimental | Other: Ultrasound assessment of gastric emptying of a flavoured yoghourt.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. |
| Parturient | Experimental | Other: Ultrasound assessment of gastric emptying of a flavoured yoghourt.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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
- gestation less than 38 weeks
- multiple pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Analgesia, Non-pregnant control, Parturient, Pregnant control |
Primary outcome
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
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
8 secondary outcomes
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
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
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
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
The rate of women having an empty stomach after the ingestion of the test meal in each group.
Time frame: 90 min
The rate of women having an empty stomach after the ingestion of the test meal in each group.
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Results publication: PubMed 35103759Bouvet 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lionel BOUVET, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound assessment of gastric emptying of a flavoured yoghourt. in people with Pregnancy and Healthy Volunteers, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03490682, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.