Randomized Control Study : Evaluation of the Benefits of Glucose Drinks During Childbirth
| Registry | NCT01022697, acronym SOLISO |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, other |
| Enrollment | 4142 (Actual) |
| Sponsor | University Hospital, Caen (Other) |
| Conditions | Childbirth |
| Interventions | Glucose drink (Other) |
| Dates | start 2008-01-01, primary completion 2012-07-01, completion 2012-07-01, first posted 2009-12-01, last updated 2026-04-02 |
| Locations | 9 sites in France |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| A | Active comparator | Other: Glucose drink | Glucose drink |
| B | No intervention | Fasting |
Sex: Female, ages: 18 Years to any, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| 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 | France |