Delivery Complicationsoliso-2NCT05080309
Effect of Oral Carbohydrate Intake > 44kCal Per Hour During Labour on the Rate of Instrumental Vaginal Delivery
A study testing carbohydrate oral intake and free water only in people with Delivery Complication and Labor Long, run by University Hospital, Caen at 1 site in France.
Trial summary
Carbohydrate intake during physical exercise improves muscle performance and decreases fatigue. We hypothesized that carbohydrate intake during labor which is a period of significant physical activity can decrease the instrumental vaginal delivery rate. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Delivery Complication, Labor Long, Pregnancy Related
- What is being tested?
- carbohydrate oral intake and free water only
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- 11 Feb 2022to 3 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- nulliparous women
- singleton pregnancy
- social insurance
- uncomplicated pregnancy
- no contraindication to vaginal delivery
Who cannot join
- scheduled caesarean section
- labor < 37 weeks of gestational age
- cervical dilation > 8cm at inclusion
- scheduled induced delivery
- contraindication to pushing effort during labor and delivery
- BMI > 40 kg/m2
- medical history of diabetes mellitus, hypertension, heart disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Carbohydrate intake during physical exercise improves muscle performance and decreases fatigue. We hypothesized that carbohydrate intake during labor which is a period of significant physical activity can decrease the instrumental vaginal delivery rate.
In a previous study we reported a trend toward a decrease in instrumental vaginal delivery and the mount of carbohydrate intake during labour. However due to some limitations no clear conclusion could be drawn.
The present study is designed to examine the relationship between a high calory oral intake (>44 kCal/hour during labour) and the rate of instrumental delivery.
- Conditions
- Delivery Complication, Labor Long, Pregnancy Related
- Being tested
- carbohydrate oral intake, free water only
- Keywords
- labor, instrumental vaginal delivery, oral intake, nulliparous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbohydrate oral intakeDietary supplement
During labor the women will have free access to water and 20 ml commercial fruit juice bricks containing between 430 or 660 kcal/l. Every 2 hours the midwife or the nurse will measure the fruit juice oral intake volume and will advise women to drink the planned volume (1 brick/2hours)
free water onlyOther
Women will have free access to water only
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | During labor the women will have free access to water only but not fruit juice or other calory source. Receives: Other: free water only |
| Carbohydrate | Experimental | During labor the women will have free access to water and 20 ml commercial fruit juice bricks containing between 430 or 660 kcal/l. Every 2 hours the midwife or the nurse will measure the fruit juice oral intake volume and will advise women to drink the planned volume (1 brick/2hours) Receives: Dietary Supplement: carbohydrate oral intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
instrumental vaginal delivery
rate of instrumental vaginal delivery
Measured: 2 days
Secondary outcomes (7)
oxytocin administration
rate of oxytocin administration
Measured: 2 days
caesarean section
rate of caesarean section
Measured: 2 days
nausea and vomiting
rate of nausea and vomiting
Measured: 2 days
thirst sensation on verbal rating scale
self evaluation of thirst using a verbal rating scale from 0 (not thirst to 10 maximal thirst)
Measured: 2 days
hunger sensation on verbal rating scale
self evaluation of hunger using a verbal rating scale from 0 (no hunger to 10 maximal hunger)
Measured: 2 days
fatigue
self evaluation of fatigue using a verbal rating scale from 0 (0 no fatigue to 10 exhausted)
Measured: 2 days
umbilical blood pH
umbilical blood pH measured at child birth
Measured: 1 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start11 Feb 2022
- Primary completion1 Feb 2028 (estimated)
- Study completion3 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delivery ComplicationStudies 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
- Model description
- controlled and monitored oral fruit juice intake in order to achieve an oral calory intake \> 44kCal/hour during labor
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jean-luc hanouz, M.D., Ph.D., Study chair, University Hospital of Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080309
- Sponsor's protocol ID
- 21-0017
- Acronym
- soliso-2
- Status last verified
- Jul 2025
- First submitted
- 22 Jul 2021
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Carbohydrate Intake > 44kCal Per Hour During Labour on the Rate of Instrumental Vaginal Delivery
- ClinicalTrials.gov ID
- NCT05080309
- Acronym / sponsor ID
- soliso-2 / 21-0017
- Conditions
- Delivery Complication, Labor Long, Pregnancy Related
- Keywords
- labor, instrumental vaginal delivery, oral intake, nulliparous
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 3 Sep 2028 (estimated)
- First posted
- 15 Oct 2021 (actual)
- 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.
Carbohydrate intake during physical exercise improves muscle performance and decreases fatigue. We hypothesized that carbohydrate intake during labor which is a period of significant physical activity can decrease the instrumental vaginal delivery rate.
In a previous study we reported a trend toward a decrease in instrumental vaginal delivery and the mount of carbohydrate intake during labour. However due to some limitations no clear conclusion could be drawn.
The present study is designed to examine the relationship between a high calory oral intake (>44 kCal/hour during labour) and the rate of instrumental delivery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- controlled and monitored oral fruit juice intake in order to achieve an oral calory intake > 44kCal/hour during labor
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Other: free water onlyDuring labor the women will have free access to water only but not fruit juice or other calory source. |
| Carbohydrate | Experimental | Dietary Supplement: carbohydrate oral intakeDuring labor the women will have free access to water and 20 ml commercial fruit juice bricks containing between 430 or 660 kcal/l. Every 2 hours the midwife or the nurse will measure the fruit juice oral intake volume and will advise women to drink the planned volume (1 brick/2hours) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- nulliparous women
- singleton pregnancy
- social insurance
- uncomplicated pregnancy
- no contraindication to vaginal delivery
Key exclusion criteria (7 listed)
- scheduled caesarean section
- labor < 37 weeks of gestational age
- cervical dilation > 8cm at inclusion
- scheduled induced delivery
- contraindication to pushing effort during labor and delivery
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 |
|---|---|---|
| carbohydrate oral intakeDuring labor the women will have free access to water and 20 ml commercial fruit juice bricks containing between 430 or 660 kcal/l. Every 2 hours the midwife or the nurse will measure the fruit juice oral intake volume and will advise women to drink the planned volume (1 brick/2hours) | Dietary supplement | Carbohydrate |
| free water onlyWomen will have free access to water only | Other | Control |
Primary outcome
instrumental vaginal delivery
Time frame: 2 days
rate of instrumental vaginal delivery
7 secondary outcomes
oxytocin administration
Time frame: 2 days
caesarean section
Time frame: 2 days
nausea and vomiting
Time frame: 2 days
thirst sensation on verbal rating scale
Time frame: 2 days
hunger sensation on verbal rating scale
Time frame: 2 days
fatigue
Time frame: 2 days
umbilical blood pH
Time frame: 1 min
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: No
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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.
jean-luc hanouz, M.D., Ph.D. study chair
University Hospital of Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing carbohydrate oral intake and free water only in people with Delivery Complication and Labor Long, run by University Hospital, Caen at 1 site 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact jean-luc hanouz (33 2 31 06 47 36, hanouz-jl@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
instrumental vaginal delivery (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2025.