Clinical trial NCT06210308: Preoperative Ultrasound Evaluation of Gastric Contents in Voluntary Termination of Pregnancy During the First Trimester
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Voluntary Termination of Pregnancy
Keywords: Voluntary Termination of Pregnancy
Preoperative gastric content
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 304
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing Voluntary termination of pregnancy by dilatation and aspiration before 14 weeks of amenorrhea

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?

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.

Primary outcomes:
measure: Prediction of gastric content by ultrasound
timeFrame: Day 0
Secondary outcomes:
measure: Prevalence of presence of gastric content
timeFrame: Day 0
measure: nausea or vomiting
timeFrame: Day 0
measure: Anesthesia protocol
timeFrame: Day 0
measure: Respiratory complications
timeFrame: At discharge from the recovery room up to one hour
Other outcomes:
Locations:
city: Metz
country: France
facility: CHR Metz-Thionville/Hopital Mercy
Study officials:
affiliation: CHR Metz Thionville Hopital Mercy
name: Léo COINUS, MD
role: PRINCIPAL_INVESTIGATOR
References: