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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06210308
Acronym
ECHONAV
Enrollment
304
Registered
2024-01-18
Start date
2024-01-01
Completion date
2024-11-01
Last updated
2025-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Voluntary Termination of Pregnancy

Keywords

Voluntary Termination of Pregnancy, Preoperative gastric content

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?

Interventions

PROCEDUREData collection from gastric ultrasound

observational study

Sponsors

Centre Hospitalier Régional Metz-Thionville
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
Prediction of gastric content by ultrasoundDay 0according to the presence of nausea or vomiting : Sensitivity, specificity, positive and negative predictive values

Secondary

MeasureTime frameDescription
Prevalence of presence of gastric contentDay 0Solid / liquid / none
nausea or vomitingDay 0Presence of nausea or vomiting on the day of surgery, or use of anti-nausea medication during pregnancy
Anesthesia protocolDay 0incidence of modification of anesthesia protocol consecutive of the realization of gastric ultrasound
Respiratory complicationsAt discharge from the recovery room up to one hourany respiratory complications that may have occurred during the operation, right up to the time of discharge from the recovery room

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026