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

Not Applicable

Recruiting

• Conditions: Pregnancy Related; Labor Long; Delivery Complication

• 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.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-22
• Study First Submitted QC: 2021-10-13
• Study First Posted: 2021-10-15
• Study Start: 2022-02-11
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-22
• Last Update Posted: 2025-07-25
• Primary Completion: 2028-02-01
• Study Completion: 2028-09-03

Recruitment & Eligibility

• Status: RECRUITING
• 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 diabetes mellitus, hypertension, heart disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
oxytocin administration	2 days	rate of oxytocin administration
caesarean section	2 days	rate of caesarean section
nausea and vomiting	2 days	rate of nausea and vomiting
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)
hunger sensation on verbal rating scale	2 days	self evaluation of hunger using 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)
umbilical blood pH	1 min	umbilical blood pH measured at child birth

Trial Locations

Locations (1)

Caen University Hospital; 🇫🇷 Caen, France