AnesthesiaEGTONCT02362815
Ultrasound Assessment of Clear Liquid Intake During Labour
A study testing Apple juice in people with Anesthesia, run by Hopital Foch at 3 sites in France.
Trial summary
We designed a two arms prospective, randomised, simple blinded trial to compare the impact of clear liquid intake on gastric content before delivery. We hypothesize that there will be no difference between the two groups, leading to safety of clear liquid intake during labour. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Anesthesia
- What is being tested?
- Apple juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 3 sitesFrance
- Study dates
- 29 Jan 2014to 30 Jan 2018
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Any pregnant woman at term
Who cannot join
- Pathologic pregnancy
- Twin pregnancy
- Body mass index above 35 kg/m2 before pregnancy
- Cervix dilation above 8 cm
- Refusal
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHI Andre Gregoire
Montreuil, 93100
Tenon
Paris, Île-de-France Region, 75020
Hopital Foch
Suresnes, Hauts-de-Seine, 92151
About this study
Official title: Fluid Intake During Labour, Ultrasound Evaluation
We designed a two arms prospective, randomised, simple blinded trial to compare the impact of clear liquid intake on gastric content before delivery. We hypothesize that there will be no difference between the two groups, leading to safety of clear liquid intake during labour.
Read the detailed description
Gastric emptying is a major concern for anesthetists in obstetric. In order to prevent the risk of gastric aspiration, we are used to forbid to eat and to drink during labour.
However, this behaviour is controversial and some studies have shown that clear liquid intake can be safe during labour. Informations from a bedside ultrasound examination of the stomach content may be a useful tool to balance benefits and risks of such attitude. This technique has recently been shown very promising in pregnant women for the assessment of the gastric volume.
- Conditions
- Anesthesia
- Being tested
- Apple juice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apple juiceOther
Intervention consists in allowing drinks during labour
| Study group | Role | What they receive |
|---|---|---|
| Apple juice | Active comparator | Patient are allowed to drink up to 400 ml of apple juice Receives: Other: Apple juice |
| Control | No intervention | Patient are not allowed to drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of parturients with a full stomach
A full stomach is defined by an antral area above 300 mm2 evaluated by ultrasound imaging
Measured: average of 6 hours
Secondary outcomes (4)
Parturient comfort
Comfort is evaluated using Labour Agentry Scale
Measured: average of 6 hours
Evolution of the antral area
Antral area are measured by gastric ultrasonography at the beginning and at the end of labour
Measured: average of 6 hours
Anxiety
Anxiety is measured by a Visual Analogic Scale
Measured: average of 6 hours
Pain intensity
Pain is measured by a Visual Analogic Scale
Measured: average of 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2015 (estimated)
- Study start29 Jan 2014
- Primary completion30 Jan 2018
- Study completion30 Jan 2018
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 AnesthesiaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02362815
- Sponsor's protocol ID
- 2013/27
- Acronym
- EGTO
- Status last verified
- Aug 2019
- First submitted
- 26 Dec 2014
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rousset J, Clariot S, Tounou F, Burey J, Hafiani EM, Feliot E, Quesnel C, Bonnet F, Fischler M. Oral fluid intake during the first stage of labour: A randomised trial. Eur J Anaesthesiol. 2020 Sep;37(9):810-817. doi: 10.1097/EJA.0000000000001278.
PubMed 32769506
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Intake During Labour, Ultrasound Evaluation
- ClinicalTrials.gov ID
- NCT02362815
- Acronym / sponsor ID
- EGTO / 2013/27
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 29 Jan 2014 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 13 Feb 2015 (estimated)
- 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.
We designed a two arms prospective, randomised, simple blinded trial to compare the impact of clear liquid intake on gastric content before delivery. We hypothesize that there will be no difference between the two groups, leading to safety of clear liquid intake during labour.
Detailed description
Gastric emptying is a major concern for anesthetists in obstetric. In order to prevent the risk of gastric aspiration, we are used to forbid to eat and to drink during labour.
However, this behaviour is controversial and some studies have shown that clear liquid intake can be safe during labour. Informations from a bedside ultrasound examination of the stomach content may be a useful tool to balance benefits and risks of such attitude. This technique has recently been shown very promising in pregnant women for the assessment of the gastric volume.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apple juice | Active comparator | Other: Apple juicePatient are allowed to drink up to 400 ml of apple juice |
| Control | No intervention | –Patient are not allowed to drink |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Any pregnant woman at term
Key exclusion criteria (5 listed)
- Pathologic pregnancy
- Twin pregnancy
- Body mass index above 35 kg/m2 before pregnancy
- Cervix dilation above 8 cm
- Refusal
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 |
|---|---|---|
| Apple juiceIntervention consists in allowing drinks during labour | Other | Apple juice |
Primary outcome
Percentage of parturients with a full stomach
Time frame: average of 6 hours
A full stomach is defined by an antral area above 300 mm2 evaluated by ultrasound imaging
4 secondary outcomes
Parturient comfort
Time frame: average of 6 hours
Evolution of the antral area
Time frame: average of 6 hours
Anxiety
Time frame: average of 6 hours
Pain intensity
Time frame: average of 6 hours
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 15 Aug 2019.
- Derived from this study: PubMed 32769506Rousset J, Clariot S, Tounou F, Burey J, Hafiani EM, Feliot E, Quesnel C, Bonnet F, Fischler M. Oral fluid intake during the first stage of labour: A randomised trial. Eur J Anaesthesiol. 2020 Sep;37(9):810-817. doi: 10.1097/EJA.0000000000001278.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apple juice in people with Anesthesia, run by Hopital Foch at 3 sites 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 1 inclusion and 5 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 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Percentage of parturients with a full stomach (time frame: average of 6 hours). 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 NCT02362815, 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 15 Aug 2019.