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

July 22, 2025 updated by: University Hospital, Caen

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Caen, France
        • Recruiting
        • Caen University hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 2 days
rate of instrumental vaginal delivery
2 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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