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

NCT03776565 | Completed

• 1 other identifier: 2017029F
• Study Type: observational
• Target: 137
• Locations: 1 country
• Sites: 2

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.

Conditions

Pregnancy Related

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Measure of Perlas score

  Before surgery

• Assessment of anxiety on gastric residue with a numeric scale

  Before surgery

• Assessment of frequency of intraoperative inhalation

  During surgery

• Incidence of fasting on gastric residue between the two populations

  Before surgery

Study Arms (2)

Operative hysteroscopy

women with an operative hysteroscopy planned

Other: Ultrasound

Planned caesarean section

Pregnant women with a planned caesarean section

Other: Ultrasound

Interventions

Ultrasound OTHER

Ultrasound of antrum of stomach

Operative hysteroscopy; Planned caesarean section

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (2)

Hopital Béclère (APHP)

Clamart, 92141, France

Location

Hopital Foch

Suresnes, 92150, France

Location

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Frederic Mercier, MD PhD

  Hopital Beclere (APHP)

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: December 14, 2018
• Study Start: November 26, 2018
• Primary Completion: November 27, 2019
• Study Completion: November 27, 2019
• Last Updated: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)