Effect of Oral Carbohydrate Intake > 44kCal Per Hour During Labour on the Rate of Instrumental Vaginal Delivery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorUniversity Hospital, Caen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
nulliparous women
singleton pregnancy
social insurance
uncomplicated pregnancy
Disqualifiers
scheduled caesarean section
labor < 37 weeks of gestational age
cervical dilation > 8cm at inclusion
scheduled induced delivery
Trial design
Design model
Parallel
Treatments tested in this trial
carbohydrate oral intake
Dietary supplementDuring 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 only
Other interventionWomen will have free access to water only
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: ControlSham comparator 1 intervention
Group B: CarbohydrateExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
instrumental vaginal delivery
rate of instrumental vaginal delivery
Time frame
2 daysSecondary outcomes
1
oxytocin administration
rate of oxytocin administration
Time frame
2 days2
caesarean section
rate of caesarean section
Time frame
2 days3
nausea and vomiting
rate of nausea and vomiting
Time frame
2 days4
thirst sensation on verbal rating scale
self evaluation of thirst using a verbal rating scale from 0 (not thirst to 10 maximal thirst)
Time frame
2 daysSponsors and contacts
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Source ClinicalTrials.gov