Preoperative Ultrasound Evaluation of Gastric Contents in Voluntary Termination of Pregnancy During the First Trimester (ECHONAV)

March 20, 2025 updated by: Centre Hospitalier Régional Metz-Thionville

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.

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.

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 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.
Observational

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.
304

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Metz, France, 57085
        • CHR Metz-Thionville/Hopital Mercy

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing Voluntary termination of pregnancy by dilatation and aspiration before 14 weeks of amenorrhea

Description

Inclusion Criteria:

  • Adult patients
  • Patients undergoing Voluntary termination of pregnancy by dilatation and aspiration before 14 weeks of amenorrhea

Exclusion Criteria:

  • 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.

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

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
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
Day 0

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
Prevalence of presence of gastric content
Time Frame: Day 0
Solid / liquid / none
Day 0
nausea or vomiting
Time Frame: Day 0
Presence of nausea or vomiting on the day of surgery, or use of anti-nausea medication during pregnancy
Day 0
Anesthesia protocol
Time Frame: Day 0
incidence of modification of anesthesia protocol consecutive of the realization of gastric ultrasound
Day 0
Respiratory complications
Time Frame: At discharge from the recovery room up to one hour
any respiratory complications that may have occurred during the operation, right up to the time of discharge from the recovery room
At discharge from the recovery room up to one hour

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.
Centre Hospitalier Régional Metz-Thionville

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: Léo COINUS, MD, CHR Metz Thionville Hopital Mercy

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.
January 1, 2024

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 1, 2024

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 1, 2024

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).
January 4, 2024

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.
January 15, 2024

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.
January 18, 2024

Study Record Updates

Last Update Posted (Actual)

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.
March 25, 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.
March 20, 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.
March 1, 2025

More Information

Terms related to this study

Keywords

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.
  • 2023-13Obs-CHRMT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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