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

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ClinicalTrials.gov Identifier: NCT01022697
Recruitment Status : Completed
First Posted : December 1, 2009
Last Update Posted : September 3, 2012
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Childbirth Other: Glucose drink Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Randomized Control Study : Evaluation of the Benefits of Glucose Drinks During Childbirth
Study Start Date : January 2008
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Childbirth
Drug Information available for: Dextrose

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



Primary Outcome Measures :
  1. Instrumental extraction rates [ Time Frame: During childbirth ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01022697


Locations
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France
Hospital, Avranches
Avranches, France
Centre Hospitalier
Bayeux, France, 14400
Clinique du Parc
Caen, France, 14000
University Hospital, Caen
Caen, France, 14033
Centre Hospitalier du Rouvray
Elbeuf, France, 76350
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, France, 50000
Sponsors and Collaborators
University Hospital, Caen
Investigators
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Principal Investigator: Thérèse SIMONET, MD University Hospital, Caen

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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT01022697     History of Changes
Other Study ID Numbers: 2007-A00585-48
First Posted: December 1, 2009    Key Record Dates
Last Update Posted: September 3, 2012
Last Verified: August 2012