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Effect of Oral Carbohydrate Intake > 44kCal Per Hour During Labour on the Rate of Instrumental Vaginal Delivery

Effect of Oral Carbohydrate Intake > 44kCal Per Hour During Labour on the Rate of Instrumental Vaginal Delivery

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05080309
Acronym
soliso-2
Enrollment
600
Registered
2021-10-15
Start date
2022-02-11
Completion date
2028-09-03
Last updated
2025-07-25

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

Conditions

Delivery Complication, Labor Long, Pregnancy Related

Keywords

labor, instrumental vaginal delivery, oral intake, nulliparous

Brief 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. 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.

Interventions

DIETARY_SUPPLEMENTcarbohydrate oral intake

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)

OTHERfree water only

Women will have free access to water only

Sponsors

University Hospital, Caen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Masking description

The outcome assessor (i.e. obstetrician) will be unaware of group allocation

Intervention model description

controlled and monitored oral fruit juice intake in order to achieve an oral calory intake \> 44kCal/hour during labor

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* nulliparous women * singleton pregnancy * social insurance * uncomplicated pregnancy * no contraindication to vaginal delivery

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
instrumental vaginal delivery2 daysrate of instrumental vaginal delivery

Secondary

MeasureTime frameDescription
caesarean section2 daysrate of caesarean section
nausea and vomiting2 daysrate of nausea and vomiting
thirst sensation on verbal rating scale2 daysself evaluation of thirst using a verbal rating scale from 0 (not thirst to 10 maximal thirst)
oxytocin administration2 daysrate of oxytocin administration
fatigue2 daysself evaluation of fatigue using a verbal rating scale from 0 (0 no fatigue to 10 exhausted)
umbilical blood pH1 minumbilical blood pH measured at child birth
hunger sensation on verbal rating scale2 daysself evaluation of hunger using a verbal rating scale from 0 (no hunger to 10 maximal hunger)

Countries

France

Contacts

Primary Contactjean-luc hanouz
hanouz-jl@chu-caen.fr33 2 31 06 47 36

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026