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Evaluation of the Benefits of Glucose Drinks During Childbirth

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01022697
Acronym
SOLISO
Enrollment
4142
Registered
2009-12-01
Start date
2008-01-01
Completion date
2012-07-01
Last updated
2026-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childbirth

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.

Interventions

200 mL each 3 hours up to 8 cm of dilatation

Sponsors

University Hospital, Caen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Instrumental extraction ratesDuring childbirth

Countries

France

Contacts

PRINCIPAL_INVESTIGATORThérèse SIMONET, MD

University Hospital, Caen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026