Ultrasound Assessment of Clear Liquid Intake During Labour

NCT ID: NCT02362815

Last Updated: 2019-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-29

Study Completion Date

2018-01-30

Brief Summary

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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

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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.

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Apple juice

Patient are allowed to drink up to 400 ml of apple juice

Group Type ACTIVE_COMPARATOR

Apple juice

Intervention Type OTHER

Intervention consists in allowing drinks during labour

Control

Patient are not allowed to drink

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Apple juice

Intervention consists in allowing drinks during labour

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hopital Foch

Suresnes, Hauts-de-Seine, France

Site Status

CHI Andre Gregoire

Montreuil, , France

Site Status

Tenon

Paris, Île-de-France Region, France

Site Status

Countries

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France

References

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Rousset J, Clariot S, Tounou F, Burey J, Hafiani EM, Feliot E, Quesnel C, Bonnet F, Fischler M. Oral fluid intake during the first stage of labour: A randomised trial. Eur J Anaesthesiol. 2020 Sep;37(9):810-817. doi: 10.1097/EJA.0000000000001278.

Reference Type DERIVED
PMID: 32769506 (View on PubMed)

Other Identifiers

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2013/27

Identifier Type: -

Identifier Source: org_study_id

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