Evaluation of the Benefits of Glucose Drinks During Childbirth

Childbirth Clinical Trial

— SOLISO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01022697
• Other study ID #: 2007-A00585-48
• Status: Completed
• Phase: N/A
• First received: November 26, 2009
• Last updated: August 31, 2012
• Start date: January 2008
• Est. completion date: July 2012

Study information

• Verified date: August 2012
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4142
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Childbirth

Intervention

Other:
• Glucose drink
200 mL each 3 hours up to 8 cm of dilatation

Locations

Country	Name	City	State
France	Hospital, Avranches	Avranches
France	Centre Hospitalier	Bayeux
France	Clinique du Parc	Caen
France	University Hospital, Caen	Caen
France	Centre Hospitalier du Rouvray	Elbeuf
France	University Hospital, Lille	Lille
France	Hospital, Mont Saint Aignan	Mont Saint Aignan
France	University Hospital, Rouen	Rouen
France	Centre Hospitalier Mémorial France Etats-Unis	Saint-Lô

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Instrumental extraction rates		During childbirth	No