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

Pregnancy Related Clinical Trial

— ECHOCESAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03776565
• Other study ID #: 2017029F
• Status: Completed
• Start date: November 26, 2018
• Est. completion date: November 27, 2019

Study information

• Verified date: December 2019
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: November 27, 2019
• Est. primary completion date: November 27, 2019
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

Other:
• Ultrasound
Ultrasound of antrum of stomach

Locations

Country	Name	City	State
France	Hopital Béclère (APHP)	Clamart
France	Hopital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Assessment of frequency of intraoperative inhalation	Comparison of proportion of inhalation between the two population	During surgery
Secondary	Incidence of fasting on gastric residue between the two populations	Comparison of antral surface with fasting as covariable	Before surgery