Skip to main content
OpenTrials
Completed

NCT Number: NCT06210308

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CHR Metz-Thionville/Hopital Mercy

Metz, 57085, France

About this study

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?

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Data collection from gastric ultrasound

Procedure

observational study

Primary outcomes

  1. 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

Secondary outcomes

  1. Prevalence of presence of gastric content

    Time frame: Day 0

    Solid / liquid / none

  2. 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

  3. Anesthesia protocol

    Time frame: Day 0

    incidence of modification of anesthesia protocol consecutive of the realization of gastric ultrasound

  4. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional Metz-Thionville

Other

Registry information

Official study 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

Acronym: ECHONAV

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 18, 2024
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.