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Clinical Trials/NCT06210308
NCT06210308
Completed
Not Applicable

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

Centre Hospitalier Régional Metz-Thionville1 site in 1 country304 target enrollmentJanuary 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Voluntary Termination of Pregnancy
Sponsor
Centre Hospitalier Régional Metz-Thionville
Enrollment
304
Locations
1
Primary Endpoint
Prediction of gastric content by ultrasound
Status
Completed
Last Updated
last year

Overview

Brief 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.

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?

Registry
clinicaltrials.gov
Start Date
January 1, 2024
End Date
November 1, 2024
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Sponsor
Centre Hospitalier Régional Metz-Thionville
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • Prevalence of presence of gastric content(Day 0)
  • Anesthesia protocol(Day 0)
  • nausea or vomiting(Day 0)
  • Respiratory complications(At discharge from the recovery room up to one hour)

Study Sites (1)

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