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

NCT06210308 | Completed

• 1 other identifier: 2023-13Obs-CHRMT
• Study Type: observational
• Target: 304
• Locations: 1 country
• Sites: 1

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.

Conditions

Voluntary Termination of Pregnancy

Keywords

Voluntary Termination of Pregnancy; Preoperative gastric content

Outcome Measures

Primary Outcomes (1)

• Prediction of gastric content by ultrasound

  according to the presence of nausea or vomiting : Sensitivity, specificity, positive and negative predictive values

  Day 0

Secondary Outcomes (4)

• Prevalence of presence of gastric content

  Day 0

• nausea or vomiting

  Day 0

• Anesthesia protocol

  Day 0

• Respiratory complications

  At discharge from the recovery room up to one hour

Interventions

Data collection from gastric ultrasound PROCEDURE

observational study

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing Voluntary termination of pregnancy by dilatation and aspiration before 14 weeks of amenorrhea

You may qualify if:

• Adult patients
• Patients undergoing Voluntary termination of pregnancy by dilatation and aspiration before 14 weeks of amenorrhea

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead

Study Sites (1)

CHR Metz-Thionville/Hopital Mercy

Metz, 57085, France

Location

Study Officials

• Léo COINUS, MD

  CHR Metz Thionville Hopital Mercy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 18, 2024
• Study Start: January 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)