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Ultrasound Assessment of Clear Liquid Intake During Labour

Fluid Intake During Labour, Ultrasound Evaluation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02362815
Acronym
EGTO
Enrollment
156
Registered
2015-02-13
Start date
2014-01-29
Completion date
2018-01-30
Last updated
2019-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

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.

Interventions

Intervention consists in allowing drinks during labour

Sponsors

Hopital Foch
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of parturients with a full stomachaverage of 6 hoursA full stomach is defined by an antral area above 300 mm2 evaluated by ultrasound imaging

Secondary

MeasureTime frameDescription
Parturient comfortaverage of 6 hoursComfort is evaluated using Labour Agentry Scale
Evolution of the antral areaaverage of 6 hoursAntral area are measured by gastric ultrasonography at the beginning and at the end of labour
Anxietyaverage of 6 hoursAnxiety is measured by a Visual Analogic Scale
Pain intensityaverage of 6 hoursPain is measured by a Visual Analogic Scale

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026