Comparison of Antrum Surface Between Women With Operative Hysteroscopy or Planned Caesarean Section (ECHOCESAR)

Gastric Ultrasound Before Planned Caesarean Section or Operative Hysteroscopy : How Much Pregnancy Changes Surface of Antrum of the Stomach ? Comparative Observational Study

Realization of a gastric ultrasound just before surgery, to measure the surface of antrum of stomach and compare if divergence sizes can be observed between women with a operative hysteroscopy and women with a planned caesarean section. To know if anaesthesia need to be adapted to the population.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related
• Intervention / Treatment: Other: Ultrasound

• Study Type: Observational
• Enrollment (Actual): 137

Contacts and Locations

Study Locations

• France
  • Clamart, France, 92141
    • Hopital Béclère (APHP)
  • Suresnes, France, 92150
    • Hopital FOCH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Women comming to hospital/sites for a planned caesarean section or operative hysteroscopy.

Description

Inclusion Criteria:

• Age between 18 and 40
• Membership of a national insurance scheme
• Written consent
• Physical status score or American Society of Anesthesiologists (ASA) score = 1 or 2
• Planned caesarean section or operative hysteroscopy

Exclusion Criteria:

• Not able to give her written consent (not speaking French), under legal protection
• Insulin-dependant diabetes
• Hiatus hernia
• History of gastro-oesophageal surgery
• Contraindication to right lateral decubitus
• Treatments with anti-acids before ultrasounds.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Operative hysteroscopy; women with an operative hysteroscopy planned	Other: Ultrasound; Ultrasound of antrum of stomach
Planned caesarean section; Pregnant women with a planned caesarean section	Other: Ultrasound; Ultrasound of antrum of stomach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of antral surface	Measure of gastric antrum surface by Ultrasound on operative hysteroscopy women and planned caesarean section women.	Just before anesthesia and surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of Perlas score	Perlas score (Grade 0, defined as an empty antrum in both the supine and the right lateral decubitus positions, indicates that the stomach is completely empty; grade 1, defined as visualisation of gastric fluid content in the right lateral position only, corresponds to low gastric fluid volume; grade 2, defined by visualisation of liquid contents in both supine and right lateral positions, suggests a high gastric fluid volume with increased risk for pulmonary aspiration) measure by Ultrasound on operative hysteroscopy women and planned caesarean section women.	Before surgery
Assessment of anxiety on gastric residue with a numeric scale	Measure of anxiety with a numeric scale (0 = no anxiety, 10 = maximal anxiety)	Before surgery
Assessment of frequency of intraoperative inhalation	Comparison of proportion of inhalation between the two population	During surgery
Incidence of fasting on gastric residue between the two populations	Comparison of antral surface with fasting as covariable	Before surgery

Collaborators and Investigators

• Sponsor: Hopital Foch
• Investigators: Study Director: Frederic Mercier, MD PhD, Hopital Béclère (APHP)

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2018
• Primary Completion (Actual): November 27, 2019
• Study Completion (Actual): November 27, 2019

Study Registration Dates

• First Submitted: November 26, 2018
• First Submitted That Met QC Criteria: December 13, 2018
• First Posted (Actual): December 14, 2018

Study Record Updates

• Last Update Posted (Actual): January 2, 2020
• Last Update Submitted That Met QC Criteria: December 31, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2017029F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No