Ultrasound Assessment of Clear Liquid Intake During Labour

Anesthesia Clinical Trial

— EGTO  

Official title:

Fluid Intake During Labour, Ultrasound Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02362815
• Other study ID #: 2013/27
• Status: Completed
• Phase: N/A
• Start date: January 29, 2014
• Est. completion date: January 30, 2018

Study information

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

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: January 30, 2018
• Est. primary completion date: January 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Other:
• Apple juice
Intervention consists in allowing drinks during labour

Locations

Country	Name	City	State
France	CHI Andre Gregoire	Montreuil
France	Tenon	Paris	Ile De France
France	Hopital Foch	Suresnes	Hauts-de-Seine

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Parturient comfort	Comfort is evaluated using Labour Agentry Scale	average of 6 hours
Secondary	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
Secondary	Anxiety	Anxiety is measured by a Visual Analogic Scale	average of 6 hours
Secondary	Pain intensity	Pain is measured by a Visual Analogic Scale	average of 6 hours