Voluntary Termination of PregnancyECHONAVNCT06210308
Preoperative Ultrasound Evaluation of Gastric Contents in Voluntary Termination of Pregnancy During the First Trimester
An observational study of Voluntary Termination of Pregnancy, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial summary
This is an observational, prospective, monocentric, diagnostic study aiming to evaluate the diagnostic properties of the presence of nausea-vomiting in predicting the existence of gastric contents in preoperative surgical abortion. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Voluntary Termination of Pregnancy
- What is being tested?
- Data collection from gastric ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 304 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2024to 1 Nov 2024
- 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 years and older
- Women only
- Adult, Older adult
Study population: Patients undergoing Voluntary termination of pregnancy by dilatation and aspiration before 14 weeks of amenorrhea
Who may be able to join
- Adult patients
- Patients undergoing Voluntary termination of pregnancy by dilatation and aspiration before 14 weeks of amenorrhea
Who cannot join
- Patient under guardianship or curatorship.
- Patient with language barrier.
- Any condition causing the patient to be considered as having a "full stomach" even before the gastric ultrasound:
- body mass index (BMI) > 40 kg/m2
- Hiatal hernia.
- History of gastric or esophageal surgery or neoplasia.
- Gastroparesis (diabetic, hepatocellular insufficiency, severe renal insufficiency, etc.).
- Opposition of the patient to the re-use of her data for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Ultrasound Evaluation of Gastric Contents in Voluntary Termination of Pregnancy (IVG) During the First Trimester: Prospective Observational Study of Patients With Gestational Nausea and Vomiting
This is an observational, prospective, monocentric, diagnostic study aiming to evaluate the diagnostic properties of the presence of nausea-vomiting in predicting the existence of gastric contents in preoperative surgical abortion.
Read the detailed description
Most surgical abortions are performed under general anaesthesia. Inhalation of gastric contents is one of the main complications of general anesthesia, in terms of frequency and severity. Patients in the 1st trimester of pregnancy are frequently subject to nausea and vomiting, even on an empty stomach. The presence of nausea and vomiting prior to surgery means that the anesthetic protocol needs to be modified, as there is a greater risk of complications, particularly allergic ones. Preoperative gastric ultrasound is recognized for its ability to predict the risk of gastric inhalation during anesthesia. It is a non-irradiating, non-invasive, painless and rapid examination. There are no data on the association between gestational nausea and vomiting and the risk of inhalation in the context of preoperative fasting. There are no data on the gastric volume of patients in the 1st trimester of pregnancy with or without nausea. Does gestational nausea and vomiting represent an anesthetic risk of gastric inhalation?
- Conditions
- Voluntary Termination of Pregnancy
- Being tested
- Data collection from gastric ultrasound
- Keywords
- Voluntary Termination of Pregnancy, Preoperative gastric content
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collection from gastric ultrasoundProcedure or surgery
observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of gastric content by ultrasound
according to the presence of nausea or vomiting : Sensitivity, specificity, positive and negative predictive values
Measured: Day 0
Secondary outcomes (4)
Prevalence of presence of gastric content
Solid / liquid / none
Measured: Day 0
nausea or vomiting
Presence of nausea or vomiting on the day of surgery, or use of anti-nausea medication during pregnancy
Measured: Day 0
Anesthesia protocol
incidence of modification of anesthesia protocol consecutive of the realization of gastric ultrasound
Measured: Day 0
Respiratory complications
any respiratory complications that may have occurred during the operation, right up to the time of discharge from the recovery room
Measured: At discharge from the recovery room up to one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start1 Jan 2024
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Voluntary Termination of PregnancyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Léo COINUS, MD, Principal investigator, CHR Metz Thionville Hopital Mercy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210308
- Sponsor's protocol ID
- 2023-13Obs-CHRMT
- Acronym
- ECHONAV
- Status last verified
- Mar 2025
- First submitted
- 4 Jan 2024
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: According to the French law and the French Data Protection Authority (CNIL), we won't be able to publicly share individual participant data, but we plan to share their conclusions through peer-reviewed publications and conferences.
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Ultrasound Evaluation of Gastric Contents in Voluntary Termination of Pregnancy (IVG) During the First Trimester: Prospective Observational Study of Patients With Gestational Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT06210308
- Acronym / sponsor ID
- ECHONAV / 2023-13Obs-CHRMT
- Conditions
- Voluntary Termination of Pregnancy
- Keywords
- Voluntary Termination of Pregnancy, Preoperative gastric content
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 18 Jan 2024 (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.
This is an observational, prospective, monocentric, diagnostic study aiming to evaluate the diagnostic properties of the presence of nausea-vomiting in predicting the existence of gastric contents in preoperative surgical abortion.
Detailed description
Most surgical abortions are performed under general anaesthesia. Inhalation of gastric contents is one of the main complications of general anesthesia, in terms of frequency and severity. Patients in the 1st trimester of pregnancy are frequently subject to nausea and vomiting, even on an empty stomach. The presence of nausea and vomiting prior to surgery means that the anesthetic protocol needs to be modified, as there is a greater risk of complications, particularly allergic ones. Preoperative gastric ultrasound is recognized for its ability to predict the risk of gastric inhalation during anesthesia. It is a non-irradiating, non-invasive, painless and rapid examination. There are no data on the association between gestational nausea and vomiting and the risk of inhalation in the context of preoperative fasting. There are no data on the gastric volume of patients in the 1st trimester of pregnancy with or without nausea. Does gestational nausea and vomiting represent an anesthetic risk of gastric inhalation?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing Voluntary termination of pregnancy by dilatation and aspiration before 14 weeks of amenorrhea
Key inclusion criteria (2 listed)
- Adult patients
- Patients undergoing Voluntary termination of pregnancy by dilatation and aspiration before 14 weeks of amenorrhea
Key exclusion criteria (8 listed)
- Patient under guardianship or curatorship.
- Patient with language barrier.
- Any condition causing the patient to be considered as having a "full stomach" even before the gastric ultrasound:
- Opposition of the patient to the re-use of her data for the study.
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 |
|---|---|---|
| Data collection from gastric ultrasoundobservational study | Procedure or surgery | – |
Primary outcome
Prediction of gastric content by ultrasound
Time frame: Day 0
according to the presence of nausea or vomiting : Sensitivity, specificity, positive and negative predictive values
4 secondary outcomes
Prevalence of presence of gastric content
Time frame: Day 0
nausea or vomiting
Time frame: Day 0
Anesthesia protocol
Time frame: Day 0
Respiratory complications
Time frame: At discharge from the recovery room up to one hour
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 21 Mar 2025.
- Individual participant dataSharing planned: No. According to the French law and the French Data Protection Authority (CNIL), we won't be able to publicly share individual participant data, but we plan to share their conclusions through peer-reviewed publications and conferences.
Related trials for Voluntary Termination of Pregnancy
Active, not recruitingObservational study
Requests for Voluntary Termination and Medical Termination of Pregnancy for Maternal, Psychological or Social Reasons At the Women's Center ( La Maison Des Femmes) in Saint-Denis :
Pregnancy, Violence Against Women (VAW)
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.
Léo COINUS, MD principal investigator
CHR Metz Thionville Hopital Mercy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Voluntary Termination of Pregnancy, run by Centre Hospitalier Régional Metz-Thionville 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 2 inclusion and 8 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 21 Mar 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?
Prediction of gastric content by ultrasound (time frame: Day 0). 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 21 Mar 2025.