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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4142 participants|
|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|
Active Comparator: A
Other: Glucose drink
200 mL each 3 hours up to 8 cm of dilatation
No Intervention: B
- Instrumental extraction rates [ Time Frame: During childbirth ]
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
|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|
|Hospital, Mont Saint Aignan|
|Mont Saint Aignan, France|
|University Hospital, Rouen|
|Centre Hospitalier Mémorial France Etats-Unis|
|Saint-Lô, France, 50000|
|Principal Investigator:||Thérèse SIMONET, MD||University Hospital, Caen|