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Evaluation of the Benefits of Glucose Drinks During Childbirth

NCT ID: NCT01022697

Last Updated: 2012-09-03

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

4142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Childbirth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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A

Glucose drink

Group Type ACTIVE_COMPARATOR

Glucose drink

Intervention Type OTHER

200 mL each 3 hours up to 8 cm of dilatation

B

Fasting

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Glucose drink

200 mL each 3 hours up to 8 cm of dilatation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thérèse SIMONET, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Caen

Locations

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Hospital, Avranches

Avranches, , France

Site Status

Centre Hospitalier

Bayeux, , France

Site Status

Clinique du Parc

Caen, , France

Site Status

University Hospital, Caen

Caen, , France

Site Status

Centre Hospitalier du Rouvray

Elbeuf, , France

Site Status

University Hospital, Lille

Lille, , France

Site Status

Hospital, Mont Saint Aignan

Mont-Saint-Aignan, , France

Site Status

University Hospital, Rouen

Rouen, , France

Site Status

Centre Hospitalier Mémorial France Etats-Unis

Saint-Lô, , France

Site Status

Countries

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France

Other Identifiers

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2007-A00585-48

Identifier Type: -

Identifier Source: org_study_id