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Completed

NCT Number: NCT01022697

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital, Avranches, Avranches, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glucose drink

Other

200 mL each 3 hours up to 8 cm of dilatation

Primary outcomes

  1. Instrumental extraction rates

    Time frame: During childbirth

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

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

Acronym: SOLISO

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Dec 1, 2009
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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