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

Completed

• Conditions: Pregnancy Related
• Interventions: Other: Ultrasound

• Registration Number: NCT03776565
• Lead Sponsor: Hopital Foch

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-26
• Study First Submitted: 2018-11-26
• Study First Submitted QC: 2018-12-13
• Study First Posted: 2018-12-14
• Primary Completion: 2019-11-27
• Study Completion: 2019-11-27
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-31
• Last Update Posted: 2020-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 137

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Operative hysteroscopy	Ultrasound	women with an operative hysteroscopy planned
Planned caesarean section	Ultrasound	Pregnant women with a planned caesarean section

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Measure of Perlas score	Before surgery	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.
Assessment of anxiety on gastric residue with a numeric scale	Before surgery	Measure of anxiety with a numeric scale (0 = no anxiety, 10 = maximal anxiety)
Incidence of fasting on gastric residue between the two populations	Before surgery	Comparison of antral surface with fasting as covariable
Assessment of frequency of intraoperative inhalation	During surgery	Comparison of proportion of inhalation between the two population

Trial Locations

Locations (2)

Hopital Béclère (APHP); 🇫🇷 Clamart, France

Hopital Foch; 🇫🇷 Suresnes, France