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

Completed

• Conditions: Voluntary Termination of Pregnancy

• Registration Number: NCT06210308
• Lead Sponsor: Centre Hospitalier Régional Metz-Thionville

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?

Study Timeline

• Study Start: 2024-01-01
• Study First Submitted: 2024-01-04
• Study First Submitted QC: 2024-01-15
• Study First Posted: 2024-01-18
• Primary Completion: 2024-11-01
• Study Completion: 2024-11-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 304

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Prevalence of presence of gastric content	Day 0	Solid / liquid / none
Anesthesia protocol	Day 0	incidence of modification of anesthesia protocol consecutive of the realization of gastric ultrasound
nausea or vomiting	Day 0	Presence of nausea or vomiting on the day of surgery, or use of anti-nausea medication during pregnancy
Respiratory complications	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

Trial Locations

Locations (1)

CHR Metz-Thionville/Hopital Mercy; 🇫🇷 Metz, France