NCT02362815

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 29, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 13, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2018

Completed
Last Updated

August 15, 2019

Status Verified

August 1, 2019

Enrollment Period

4 years

First QC Date

December 26, 2014

Last Update Submit

August 13, 2019

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Percentage of parturients with a full stomach

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

    average of 6 hours

Secondary Outcomes (4)

  • Parturient comfort

    average of 6 hours

  • Evolution of the antral area

    average of 6 hours

  • Anxiety

    average of 6 hours

  • Pain intensity

    average of 6 hours

Study Arms (2)

Apple juice

ACTIVE COMPARATOR

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

Other: Apple juice

Control

NO INTERVENTION

Patient are not allowed to drink

Interventions

Apple juiceOTHER

Intervention consists in allowing drinks during labour

Apple juice

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Any pregnant woman at term

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hopital Foch

Suresnes, Hauts-de-Seine, 92151, France

Location

CHI Andre Gregoire

Montreuil, 93100, France

Location

Tenon

Paris, Île-de-France Region, 75020, France

Location

Related Publications (1)

  • 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.

    PMID: 32769506DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2014

First Posted

February 13, 2015

Study Start

January 29, 2014

Primary Completion

January 30, 2018

Study Completion

January 30, 2018

Last Updated

August 15, 2019

Record last verified: 2019-08

Locations

FR(3)