Evaluation of the Benefits of Glucose Drinks During Childbirth (SOLISO)

August 31, 2012 updated by: University Hospital, Caen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Avranches, France
        • Hospital, Avranches
      • Bayeux, France, 14400
        • Centre Hospitalier
      • Caen, France, 14033
        • University Hospital, Caen
      • Caen, France, 14000
        • Clinique du Parc
      • Elbeuf, France, 76350
        • Centre Hospitalier du Rouvray
      • Lille, France
        • University Hospital, Lille
      • Mont Saint Aignan, France
        • Hospital, Mont Saint Aignan
      • Rouen, France
        • University Hospital, Rouen
      • Saint-Lô, France, 50000
        • Centre Hospitalier Mémorial France Etats-Unis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Glucose drink
Other: Glucose drink
200 mL each 3 hours up to 8 cm of dilatation
No Intervention: B
Fasting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Instrumental extraction rates
Time Frame: During childbirth
During childbirth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Investigators

  • Principal Investigator: Thérèse SIMONET, MD, University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

November 26, 2009

First Submitted That Met QC Criteria

November 30, 2009

First Posted (Estimate)

December 1, 2009

Study Record Updates

Last Update Posted (Estimate)

September 3, 2012

Last Update Submitted That Met QC Criteria

August 31, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • 2007-A00585-48

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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