Pregnancy RelatedECHOCESARNCT03776565
Comparison of Antrum Surface Between Women With Operative Hysteroscopy or Planned Caesarean Section
An observational study of Pregnancy Related, run by Hopital Foch at 2 sites in France.
Trial summary
Realization of a gastric ultrasound just before surgery, to measure the surface of antrum of stomach and compare if divergence sizes can be observed between women with a operative hysteroscopy and women with a planned caesarean section. To know if anaesthesia need to be adapted to the population. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Ultrasound
- How many people
- 137 participants
- Where
- 2 sitesFrance
- Study dates
- 26 Nov 2018to 27 Nov 2019
- Phase
- Observational
- 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
- Adult
Study population: Women comming to hospital/sites for a planned caesarean section or operative hysteroscopy.
Who may be able to join
- Age between 18 and 40
- Membership of a national insurance scheme
- Written consent
- Physical status score or American Society of Anesthesiologists (ASA) score = 1 or 2
- Planned caesarean section or operative hysteroscopy
Who cannot join
- Not able to give her written consent (not speaking French), under legal protection
- Insulin-dependant diabetes
- Hiatus hernia
- History of gastro-oesophageal surgery
- Contraindication to right lateral decubitus
- Treatments with anti-acids before ultrasounds.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hopital Béclère (APHP)
Clamart, 92141
Hopital Foch
Suresnes, 92150
About this study
Official title: Gastric Ultrasound Before Planned Caesarean Section or Operative Hysteroscopy : How Much Pregnancy Changes Surface of Antrum of the Stomach ? Comparative Observational Study
Realization of a gastric ultrasound just before surgery, to measure the surface of antrum of stomach and compare if divergence sizes can be observed between women with a operative hysteroscopy and women with a planned caesarean section. To know if anaesthesia need to be adapted to the population.
- Conditions
- Pregnancy Related
- Being tested
- Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundOther
Ultrasound of antrum of stomach
| Study group | Role | What they receive |
|---|---|---|
| Operative hysteroscopy | women with an operative hysteroscopy planned Receives: Other: Ultrasound | |
| Planned caesarean section | Pregnant women with a planned caesarean section Receives: Other: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of antral surface
Measure of gastric antrum surface by Ultrasound on operative hysteroscopy women and planned caesarean section women.
Measured: Just before anesthesia and surgery
Secondary outcomes (4)
Measure of Perlas score
Perlas score (Grade 0, defined as an empty antrum in both the supine and the right lateral decubitus positions, indicates that the stomach is completely empty; grade 1, defined as visualisation of gastric fluid content in the right lateral position only, corresponds to low gastric fluid volume; grade 2, defined by visualisation of liquid contents in both supine and right lateral positions, suggests a high gastric fluid volume with increased risk for pulmonary aspiration) measure by Ultrasound on operative hysteroscopy women and planned caesarean section women.
Measured: Before surgery
Assessment of anxiety on gastric residue with a numeric scale
Measure of anxiety with a numeric scale (0 = no anxiety, 10 = maximal anxiety)
Measured: Before surgery
Assessment of frequency of intraoperative inhalation
Comparison of proportion of inhalation between the two population
Measured: During surgery
Incidence of fasting on gastric residue between the two populations
Comparison of antral surface with fasting as covariable
Measured: Before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start26 Nov 2018
- Primary completion27 Nov 2019
- Study completion27 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederic Mercier, MD PhD, Study director, Hopital Beclere (APHP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776565
- Sponsor's protocol ID
- 2017029F
- Acronym
- ECHOCESAR
- Status last verified
- Dec 2019
- First submitted
- 26 Nov 2018
- Last updated
- 2 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Ultrasound Before Planned Caesarean Section or Operative Hysteroscopy : How Much Pregnancy Changes Surface of Antrum of the Stomach ? Comparative Observational Study
- ClinicalTrials.gov ID
- NCT03776565
- Acronym / sponsor ID
- ECHOCESAR / 2017029F
- Conditions
- Pregnancy Related
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 27 Nov 2019 (actual)
- Study completion
- 27 Nov 2019 (actual)
- First posted
- 14 Dec 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.
Realization of a gastric ultrasound just before surgery, to measure the surface of antrum of stomach and compare if divergence sizes can be observed between women with a operative hysteroscopy and women with a planned caesarean section. To know if anaesthesia need to be adapted to the population.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Operative hysteroscopy | – | Other: Ultrasoundwomen with an operative hysteroscopy planned |
| Planned caesarean section | – | Other: UltrasoundPregnant women with a planned caesarean section |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women comming to hospital/sites for a planned caesarean section or operative hysteroscopy.
Key inclusion criteria (5 listed)
- Age between 18 and 40
- Membership of a national insurance scheme
- Written consent
- Physical status score or American Society of Anesthesiologists (ASA) score = 1 or 2
- Planned caesarean section or operative hysteroscopy
Key exclusion criteria (6 listed)
- Not able to give her written consent (not speaking French), under legal protection
- Insulin-dependant diabetes
- Hiatus hernia
- History of gastro-oesophageal surgery
- Contraindication to right lateral decubitus
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 |
|---|---|---|
| UltrasoundUltrasound of antrum of stomach | Other | Operative hysteroscopy, Planned caesarean section |
Primary outcome
Measure of antral surface
Time frame: Just before anesthesia and surgery
Measure of gastric antrum surface by Ultrasound on operative hysteroscopy women and planned caesarean section women.
4 secondary outcomes
Measure of Perlas score
Time frame: Before surgery
Assessment of anxiety on gastric residue with a numeric scale
Time frame: Before surgery
Assessment of frequency of intraoperative inhalation
Time frame: During surgery
Incidence of fasting on gastric residue between the two populations
Time frame: Before surgery
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 2 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Pregnancy Related
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Not yet recruitingObservational study
Obesity-Related Indices and Albuminuria in Type 2 Diabetes
Obesity and Diabetes Mellitus, Type 2, Albuminuria
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Not yet recruiting
Transcranial Magnetic Stimulation for Methamphetamine Use Disorder During Pregnancy
Methamphetamine Use Disorder, Pregnancy
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.
Frederic Mercier, MD PhD study director
Hopital Beclere (APHP)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related, run by Hopital Foch at 2 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 5 inclusion and 6 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 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Measure of antral surface (time frame: Just before anesthesia and surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jan 2020.