NCT01022697

Brief Summary

Fear of full stomach when emergency general anaesthesia is required is the origin of fastening when giving birth. This behaviour does not warranty perfect security for the general anaesthesia. In addition, well being for women and new born is affected. Giving birth is finally compared to a sportive competition with high-energy needs. As Intravenous energy intake is not regulated by physiologic digestion, it can induce metabolic disorders for the mother that can be amplified for the foetus. Oral glucose drinks could offer some benefits:

  • gastric acidity would be decreased without significant increase in volumes.
  • energy intake would further more active and more efficiency labour
  • an increase in foetus well being However, it has never been shown yet that such behaviour could offer those benefits. Also, it seems that there is not more vomiting, but most of the studies compared oral glucose intake to waterborne intake with the same volumes The expected efficacy is a reduction in labour duration and a reduction in percentage of extraction. Previous studies said that the lack of statistical power due to small number of subjects caused the absence of statistical significant relationship. In addition, even though newborn have less acidosis, there is no clinical relationship proven. The investigators propose a randomised multicentre study to assess efficacy of oral glucose drinks in comparison to traditional fastening when giving birth. Main objective is to significantly reduce instrumental extraction rates. 5400 women will be included in the study in 2 years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4,142

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

9 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 1, 2008

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 26, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 1, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

April 2, 2026

Status Verified

August 1, 2012

Enrollment Period

4.5 years

First QC Date

November 26, 2009

Last Update Submit

March 30, 2026

Conditions

Childbirth

Outcome Measures

Primary Outcomes (1)

  • Instrumental extraction rates

    During childbirth

Study Arms (2)

A

ACTIVE COMPARATOR

Glucose drink

Other: Glucose drink

B

NO INTERVENTION

Fasting

Interventions

Glucose drinkOTHER

200 mL each 3 hours up to 8 cm of dilatation

A

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>= 18 yrs
  • Entering for childbirth
  • Informed written consent

You may not qualify if:

  • more of 8 cm of dilatation
  • Caesarean section planned
  • natural delivery non-indicated
  • pre-partum hemostasis troubles
  • salicylic acid or anticoagulant treatment
  • pre-eclampsia or HELLP syndrome
  • diabetic neuropsy with troubles in gastric emptying
  • IMC \> 40 at the end of pregnancy
  • understanding of the information
  • under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Hospital, Avranches

Avranches, France

Location

Centre Hospitalier

Bayeux, 14400, France

Location

Clinique du Parc

Caen, 14000, France

Location

University Hospital, Caen

Caen, 14033, France

Location

Centre Hospitalier du Rouvray

Elbeuf, 76350, France

Location

University Hospital, Lille

Lille, France

Location

Hospital, Mont Saint Aignan

Mont-Saint-Aignan, France

Location

University Hospital, Rouen

Rouen, France

Location

Centre Hospitalier Mémorial France Etats-Unis

Saint-Lô, 50000, France

Location

Related Publications (1)

  • Simonet T, Gakuba C, Desmeulles I, Corouge J, Beucher G, Morello R, Gerard JL, Ducloy-Bouthors AS, Dreyfus M, Hanouz JL. Effect of Oral Carbohydrate Intake During Labor on the Rate of Instrumental Vaginal Delivery: A Multicenter, Randomized Controlled Trial. Anesth Analg. 2020 Jun;130(6):1670-1677. doi: 10.1213/ANE.0000000000004515.

    PMID: 31702699RESULT

Study Officials

  • Thérèse SIMONET, MD

    University Hospital, Caen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2009

First Posted

December 1, 2009

Study Start

January 1, 2008

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

April 2, 2026

Record last verified: 2012-08

Locations

FR(9)