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

NCT ID: NCT06210308

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 304 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-11-01

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?

Conditions

Voluntary Termination of Pregnancy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Data collection from gastric ultrasound

observational study

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Régional Metz-Thionville

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Léo COINUS, MD

Role: PRINCIPAL_INVESTIGATOR

CHR Metz Thionville Hopital Mercy

Locations

CHR Metz-Thionville/Hopital Mercy

Metz, , France

Countries

France

Other Identifiers

2023-13Obs-CHRMT

Identifier Type: -

Identifier Source: org_study_id