Ultrasound Assessment of Clear Liquid Intake During Labour (EGTO)

Fluid Intake During Labour, Ultrasound Evaluation

We designed a two arms prospective, randomised, simple blinded trial to compare the impact of clear liquid intake on gastric content before delivery. We hypothesize that there will be no difference between the two groups, leading to safety of clear liquid intake during labour.

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Other: Apple juice

Detailed Description

Gastric emptying is a major concern for anesthetists in obstetric. In order to prevent the risk of gastric aspiration, we are used to forbid to eat and to drink during labour.

However, this behaviour is controversial and some studies have shown that clear liquid intake can be safe during labour. Informations from a bedside ultrasound examination of the stomach content may be a useful tool to balance benefits and risks of such attitude. This technique has recently been shown very promising in pregnant women for the assessment of the gastric volume.

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montreuil, France, 93100
    • CHI André Grégoire
  • Hauts-de-Seine
    • Suresnes, Hauts-de-Seine, France, 92151
      • Hopital Foch
  • Ile De France
    • Paris, Ile De France, France, 75020
      • Tenon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Any pregnant woman at term

Exclusion Criteria:

• Pathologic pregnancy
• Twin pregnancy
• Body mass index above 35 kg/m2 before pregnancy
• Cervix dilation above 8 cm
• Refusal

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Apple juice; Patient are allowed to drink up to 400 ml of apple juice	Other: Apple juice; Intervention consists in allowing drinks during labour
No Intervention: Control; Patient are not allowed to drink

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of parturients with a full stomach	A full stomach is defined by an antral area above 300 mm2 evaluated by ultrasound imaging	average of 6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parturient comfort	Comfort is evaluated using Labour Agentry Scale	average of 6 hours
Evolution of the antral area	Antral area are measured by gastric ultrasonography at the beginning and at the end of labour	average of 6 hours
Anxiety	Anxiety is measured by a Visual Analogic Scale	average of 6 hours
Pain intensity	Pain is measured by a Visual Analogic Scale	average of 6 hours

Collaborators and Investigators

• Sponsor: Hopital Foch

Publications and helpful links

General Publications

• Rousset J, Clariot S, Tounou F, Burey J, Hafiani EM, Feliot E, Quesnel C, Bonnet F, Fischler M. Oral fluid intake during the first stage of labour: A randomised trial. Eur J Anaesthesiol. 2020 Sep;37(9):810-817. doi: 10.1097/EJA.0000000000001278.

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2014
• Primary Completion (Actual): January 30, 2018
• Study Completion (Actual): January 30, 2018

Study Registration Dates

• First Submitted: December 26, 2014
• First Submitted That Met QC Criteria: February 12, 2015
• First Posted (Estimate): February 13, 2015

Study Record Updates

• Last Update Posted (Actual): August 15, 2019
• Last Update Submitted That Met QC Criteria: August 13, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2013/27