Effect of Oral Carbohydrate Intake > 44kCal Per Hour During Labour on the Rate of Instrumental Vaginal Delivery (soliso-2)

Caen University Hospital

Status: Enrolling

Conditions: Pregnancy Related; Labor Long; Delivery Complication

Treatments: Dietary Supplement: carbohydrate oral intake; Other: free water only

Study type: Interventional

Funder types: Other

Identifiers

NCT05080309

21-0017

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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600 participants in 2 patient groups

Control

Sham Comparator group

Description:

During labor the women will have free access to water only but not fruit juice or other calory source.

Treatment:

Other: free water only

Carbohydrate

Experimental group

Description:

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)

Treatment:

Dietary Supplement: carbohydrate oral intake