Evaluation of the Benefits of Glucose Drinks During Childbirth

Not Applicable

Completed

• Conditions: Childbirth
• Interventions: Other: Glucose drink

• Registration Number: NCT01022697
• Lead Sponsor: University Hospital, Caen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2009-11-26
• Study First Submitted QC: 2009-11-30
• Study First Posted: 2009-12-01
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-31
• Last Update Posted: 2012-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 4142

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Glucose drink	Glucose drink

Primary Outcome Measures

Name	Time	Method
Instrumental extraction rates	During childbirth

Trial Locations

Locations (9)

Clinique du Parc; 🇫🇷 Caen, France

Hospital, Avranches; 🇫🇷 Avranches, France

University Hospital, Rouen; 🇫🇷 Rouen, France

Centre Hospitalier du Rouvray; 🇫🇷 Elbeuf, France

Centre Hospitalier; 🇫🇷 Bayeux, France

University Hospital, Lille; 🇫🇷 Lille, France

University Hospital, Caen; 🇫🇷 Caen, France

Centre Hospitalier Mémorial France Etats-Unis; 🇫🇷 Saint-Lô, France

Hospital, Mont Saint Aignan; 🇫🇷 Mont Saint Aignan, France