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

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Related; Delivery Complication; Labor Long
• Intervention / Treatment: Other: free water only; Dietary supplement: carbohydrate oral intake

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: jean-luc hanouz; Phone Number: 33 2 31 06 47 36; Email: hanouz-jl@chu-caen.fr

Study Locations

• France
  • Caen, France
    • Recruiting
    • Caen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control; During labor the women will have free access to water only but not fruit juice or other calory source.	Other: free water only; Women will have free access to water only
Experimental: Carbohydrate; 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)	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
instrumental vaginal delivery	rate of instrumental vaginal delivery	2 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Investigators: Study Chair: jean-luc hanouz, M.D., Ph.D., University hospital of Caen

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2022
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): September 3, 2028

Study Registration Dates

• First Submitted: July 22, 2021
• First Submitted That Met QC Criteria: October 13, 2021
• First Posted (Actual): October 15, 2021

Study Record Updates

• Last Update Posted (Actual): July 25, 2025
• Last Update Submitted That Met QC Criteria: July 22, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: labor; oral intake; nulliparous; instrumental vaginal delivery
• Other Study ID Numbers: 21-0017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No