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

C

Centre Hospitalier Régional Metz-Thionville

Status

Enrolling

Conditions

Voluntary Termination of Pregnancy

Treatments

Procedure: Data collection from gastric ultrasound

Study type

Observational

Funder types

Other

Identifiers

NCT06210308
2023-13Obs-CHRMT

Details and patient eligibility

About

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.

Full 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?

Enrollment

200 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

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Central trial contact

Arpiné EL NAR, PhD

Data sourced from clinicaltrials.gov

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