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

Not Applicable

• Conditions: Pregnancy Related; Labor Long; Delivery Complication
• Interventions: Other: free water only; Dietary Supplement: carbohydrate oral intake

• Registration Number: NCT05080309
• Lead Sponsor: University Hospital, Caen

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.

Following Siliso study we found a trend toward a decrease in instrumental vaginal delivery and the mount of carbohydrate intake durong 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-07-22
• Study First Submitted QC: 2021-10-13
• Last Update Submitted: 2021-10-13
• Study First Posted: 2021-10-15
• Last Update Posted: 2021-10-15
• Study Start: 2021-11-01
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 600

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 daibetes mellitus, hypertension, heart disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	free water only	During labor the women will have free access to water only but not fruit juice or other calory source.
Carbohydrate	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)

Primary Outcome Measures

Name	Time	Method
instrumental vaginal delivery	2 days	rate of instrumental vaginal delivery

Secondary Outcome Measures

Name	Time	Method
caesarean section	2 days	rate of caesarean section
nausea and vomiting	2 days	rate of nausea and vomiting
oxytocin administration	2 days	rate of oxytocin administration
hunger sensation on verbal rating scale	2 days	self evaluation of hunge rusing a verbal rating scale from 0 (no hunger to 10 maximal hunger)
fatigue	2 days	self evaluation of fatigue using a verbal rating scale from 0 (0 no fatigue to 10 exhausted)
thirst sensation on verbal rating scale	2 days	self evaluation of thirst using a verbal rating scale from 0 (not thirst to 10 maximal thirst)
umbilical blood pH	1 min	umbilical blood pH measured at child birth