Clinical trial NCT01022697: Evaluation of the Benefits of Glucose Drinks During Childbirth
Official title: Randomized Control Study : Evaluation of the Benefits of Glucose Drinks During Childbirth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childbirth
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2009-12-01
Enrollment: 4142
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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

Primary outcomes:
measure: Instrumental extraction rates
timeFrame: During childbirth
Secondary outcomes:
Other outcomes:
Locations:
city: Avranches
country: France
facility: Hospital, Avranches
city: Bayeux
country: France
facility: Centre Hospitalier
city: Caen
country: France
facility: Clinique du Parc
city: Caen
country: France
facility: University Hospital, Caen
city: Elbeuf
country: France
facility: Centre Hospitalier du Rouvray
city: Lille
country: France
facility: University Hospital, Lille
city: Mont Saint Aignan
country: France
facility: Hospital, Mont Saint Aignan
city: Rouen
country: France
facility: University Hospital, Rouen
city: Saint-Lô
country: France
facility: Centre Hospitalier Mémorial France Etats-Unis
Study officials:
affiliation: University Hospital, Caen
name: Thérèse SIMONET, MD
role: PRINCIPAL_INVESTIGATOR
References: