Effect of Oral Carbohydrate Intake > 44kCal Per Hour During Labour on the Rate of Instrumental Vaginal Delivery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: carbohydrate oral intake, free water only.
- Who it may be relevant to
- Registry conditions: Delivery Complication, Labor Long, Pregnancy Related. Basic parameters: 18 years — 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 supplement carbohydrate 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) - Other free water only
Women will have free access to water only
Primary outcome measures
- instrumental vaginal delivery [Time frame: 2 days]
Secondary outcome measures (7)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
France · 1 center
- Caen University Hospital — Caen
Identifiers
NCT: NCT05080309 · 21-0017