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OpenTrials
Completed

NCT Number: NCT03776565

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

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.

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Key information

Conditions

Pregnancy Related

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Hopital Béclère (APHP), Clamart, France

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ultrasound

Other

Ultrasound of antrum of stomach

Primary outcomes

  1. Measure of antral surface

    Time frame: Just before anesthesia and surgery

    Measure of gastric antrum surface by Ultrasound on operative hysteroscopy women and planned caesarean section women.

Secondary outcomes

  1. Measure of Perlas score

    Time frame: 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.

  2. Assessment of anxiety on gastric residue with a numeric scale

    Time frame: Before surgery

    Measure of anxiety with a numeric scale (0 = no anxiety, 10 = maximal anxiety)

  3. Assessment of frequency of intraoperative inhalation

    Time frame: During surgery

    Comparison of proportion of inhalation between the two population

  4. Incidence of fasting on gastric residue between the two populations

    Time frame: Before surgery

    Comparison of antral surface with fasting as covariable

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study title

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

Acronym: ECHOCESAR

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 14, 2018
Registry last updated
Jan 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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