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Trials / Completed

CompletedNCT01022697

Evaluation of the Benefits of Glucose Drinks During Childbirth

Randomized Control Study : Evaluation of the Benefits of Glucose Drinks During Childbirth

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
4,142 (actual)
Sponsor
University Hospital, Caen · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERGlucose drink200 mL each 3 hours up to 8 cm of dilatation

Timeline

Start date
2008-01-01
Primary completion
2012-07-01
Completion
2012-07-01
First posted
2009-12-01
Last updated
2026-04-02

Locations

9 sites across 1 country: France

Source: ClinicalTrials.gov record NCT01022697. Inclusion in this directory is not an endorsement.