ChildbirthSOLISONCT01022697
Evaluation of the Benefits of Glucose Drinks During Childbirth
A study testing Glucose drink in people with Childbirth, run by University Hospital, Caen at 9 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Childbirth
- What is being tested?
- Glucose drink
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,142 participants
- Where
- 9 sitesFrance
- Study dates
- Jan 2008to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >= 18 yrs
- Entering for childbirth
- Informed written consent
Who cannot join
- 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
Show all 10Show fewer
- diabetic neuropsy with troubles in gastric emptying
- IMC > 40 at the end of pregnancy
- understanding of the information
- under guardianship
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Hospital, Avranches
Avranches
Centre Hospitalier
Bayeux, 14400
Clinique du Parc
Caen, 14000
University Hospital, Caen
Caen, 14033
Centre Hospitalier du Rouvray
Elbeuf, 76350
University Hospital, Lille
Lille
Hospital, Mont Saint Aignan
Mont-Saint-Aignan
University Hospital, Rouen
Rouen
Centre Hospitalier Mémorial France Etats-Unis
Saint-Lô, 50000
About this study
Official title: Randomized Control Study : 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:
Read more
- 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.
- Conditions
- Childbirth
- Being tested
- Glucose drink
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose drinkOther
200 mL each 3 hours up to 8 cm of dilatation
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Glucose drink Receives: Other: Glucose drink |
| B | No intervention | Fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Instrumental extraction rates
Measured: During childbirth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2009 (estimated)
- Study startJan 2008
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ChildbirthStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,142 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thérèse SIMONET, MD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01022697
- Sponsor's protocol ID
- 2007-A00585-48
- Acronym
- SOLISO
- Status last verified
- Aug 2012
- First submitted
- 26 Nov 2009
- Last updated
- 2 Apr 2026
- Results posted
- No
Publications
Simonet T, Gakuba C, Desmeulles I, Corouge J, Beucher G, Morello R, Gerard JL, Ducloy-Bouthors AS, Dreyfus M, Hanouz JL. Effect of Oral Carbohydrate Intake During Labor on the Rate of Instrumental Vaginal Delivery: A Multicenter, Randomized Controlled Trial. Anesth Analg. 2020 Jun;130(6):1670-1677. doi: 10.1213/ANE.0000000000004515.
PubMed 31702699
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Study : Evaluation of the Benefits of Glucose Drinks During Childbirth
- ClinicalTrials.gov ID
- NCT01022697
- Acronym / sponsor ID
- SOLISO / 2007-A00585-48
- Conditions
- Childbirth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,142 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 1 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Other: Glucose drinkGlucose drink |
| B | No intervention | –Fasting |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >= 18 yrs
- Entering for childbirth
- Informed written consent
Key exclusion criteria (10 listed)
- more of 8 cm of dilatation
- Caesarean section planned
- natural delivery non-indicated
- pre-partum hemostasis troubles
- salicylic acid or anticoagulant treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucose drink200 mL each 3 hours up to 8 cm of dilatation | Other | A |
Primary outcome
Instrumental extraction rates
Time frame: During childbirth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Results publication: PubMed 31702699Simonet T, Gakuba C, Desmeulles I, Corouge J, Beucher G, Morello R, Gerard JL, Ducloy-Bouthors AS, Dreyfus M, Hanouz JL. Effect of Oral Carbohydrate Intake During Labor on the Rate of Instrumental Vaginal Delivery: A Multicenter, Randomized Controlled Trial. Anesth Analg. 2020 Jun;130(6):1670-1677. doi: 10.1213/ANE.0000000000004515.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thérèse SIMONET, MD principal investigator
University Hospital, Caen
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose drink in people with Childbirth, run by University Hospital, Caen at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Instrumental extraction rates (time frame: During childbirth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01022697, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.