EGTO: Ultrasound Assessment of Clear Liquid Intake During Labour

• Sponsor: Hopital Foch (Other)
• Overall Status: Completed
• CT.gov ID: NCT02362815
• Collaborator: (none)
• Enrollment: 156
• Locations: 3
• Arms: 2
• Actual Duration (Months): 48
• Patients Per Site: 52
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Other: Apple juice	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 156 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Fluid Intake During Labour, Ultrasound Evaluation
• Actual Study Start Date: Jan 29, 2014
• Actual Primary Completion Date: Jan 30, 2018
• Actual Study Completion Date: Jan 30, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Parturient comfort [average of 6 hours]

   Comfort is evaluated using Labour Agentry Scale

2. 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

3. Anxiety [average of 6 hours]

   Anxiety is measured by a Visual Analogic Scale

4. Pain intensity [average of 6 hours]

   Pain is measured by a Visual Analogic Scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hopital Foch	Suresnes	Hauts-de-Seine	France	92151
2	Tenon	Paris	Ile De France	France	75020
3	CHI Andre Gregoire	Montreuil		France	93100

Sponsors and Collaborators

• Hopital Foch

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hopital Foch
• ClinicalTrials.gov Identifier: NCT02362815
• Other Study ID Numbers: 2013/27
• First Posted: Feb 13, 2015
• Last Update Posted: Aug 15, 2019
• Last Verified: Aug 1, 2019

Study Results

No Results Posted as of Aug 15, 2019