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

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: Completed
• Conditions: Voluntary Termination of Pregnancy
• Intervention / Treatment: Procedure: Data collection from gastric ultrasound

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: Observational
• Enrollment (Actual): 304

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prediction of gastric content by ultrasound	according to the presence of nausea or vomiting : Sensitivity, specificity, positive and negative predictive values	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of presence of gastric content	Solid / liquid / none	Day 0
nausea or vomiting	Presence of nausea or vomiting on the day of surgery, or use of anti-nausea medication during pregnancy	Day 0
Anesthesia protocol	incidence of modification of anesthesia protocol consecutive of the realization of gastric ultrasound	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	At discharge from the recovery room up to one hour

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional Metz-Thionville
• Investigators: Principal Investigator: Léo COINUS, MD, CHR Metz Thionville Hopital Mercy

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): November 1, 2024
• Study Completion (Actual): November 1, 2024

Study Registration Dates

• First Submitted: January 4, 2024
• First Submitted That Met QC Criteria: January 15, 2024
• First Posted (Actual): January 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 20, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Voluntary Termination of Pregnancy; Preoperative gastric content
• Other Study ID 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