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

Voluntary Termination of Pregnancy Clinical Trial

— ECHONAV  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06210308
• Other study ID #: 2023-13Obs-CHRMT
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: October 1, 2024

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Régional Metz-Thionville
• Contact: Arpiné EL NAR, PhD
• Phone: 0033387557766
• Email: projet-recherche-clinique[@]chr-metz-thionville.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Voluntary Termination of Pregnancy

Intervention

Procedure:
• Data collection from gastric ultrasound
observational study

Locations

Country	Name	City	State
France	CHR Metz-Thionville/Hopital Mercy	Metz

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional Metz-Thionville

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prediction of gastric content by ultrasound	according to the presence of nausea or vomiting : Sensitivity, specificity, positive and negative predictive values	Day 0
Secondary	Prevalence of presence of gastric content	Solid / liquid / none	Day 0
Secondary	nausea or vomiting	Presence of nausea or vomiting on the day of surgery, or use of anti-nausea medication during pregnancy	Day 0
Secondary	Anesthesia protocol	incidence of modification of anesthesia protocol consecutive of the realization of gastric ultrasound	Day 0
Secondary	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