Ultrasound Assessment of Clear Liquid Intake During Labour

Not Applicable

Completed

• Conditions: Anesthesia
• Interventions: Other: Apple juice

• Registration Number: NCT02362815
• Lead Sponsor: Hopital Foch

Brief 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.

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 Timeline

• Study Start: 2014-01-29
• Study First Submitted: 2014-12-26
• Study First Submitted QC: 2015-02-12
• Study First Posted: 2015-02-13
• Primary Completion: 2018-01-30
• Study Completion: 2018-01-30
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-13
• Last Update Posted: 2019-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 156

Inclusion Criteria

• Any pregnant woman at term

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Apple juice	Apple juice	Patient are allowed to drink up to 400 ml of apple juice

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Tenon; 🇫🇷 Paris, Ile De France, France

CHI Andre Gregoire; 🇫🇷 Montreuil, France

Hopital Foch; 🇫🇷 Suresnes, Hauts-de-Seine, France