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Completed

NCT Number: NCT02362815

Ultrasound Assessment of Clear Liquid Intake During Labour

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.

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Key information

Conditions

Anesthesia

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Foch, Suresnes, Hauts-de-Seine, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apple juice

Other

Intervention consists in allowing drinks during labour

Primary outcomes

  1. Percentage of parturients with a full stomach

    Time frame: average of 6 hours

    A full stomach is defined by an antral area above 300 mm2 evaluated by ultrasound imaging

Secondary outcomes

  1. Parturient comfort

    Time frame: average of 6 hours

    Comfort is evaluated using Labour Agentry Scale

  2. Evolution of the antral area

    Time frame: average of 6 hours

    Antral area are measured by gastric ultrasonography at the beginning and at the end of labour

  3. Anxiety

    Time frame: average of 6 hours

    Anxiety is measured by a Visual Analogic Scale

  4. Pain intensity

    Time frame: average of 6 hours

    Pain is measured by a Visual Analogic Scale

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study title

Fluid Intake During Labour, Ultrasound Evaluation

Acronym: EGTO

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Feb 13, 2015
Registry last updated
Aug 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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