NCT05080309

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
28mo left

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Feb 2022Sep 2028

First Submitted

Initial submission to the registry

July 22, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 15, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

February 11, 2022

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2028

Last Updated

July 25, 2025

Status Verified

July 1, 2025

Enrollment Period

6 years

First QC Date

July 22, 2021

Last Update Submit

July 22, 2025

Conditions

Delivery ComplicationLabor LongPregnancy Related

Keywords

laborinstrumental vaginal deliveryoral intakenulliparous

Outcome Measures

Primary Outcomes (1)

  • instrumental vaginal delivery

    rate of instrumental vaginal delivery

    2 days

Secondary Outcomes (7)

  • oxytocin administration

    2 days

  • caesarean section

    2 days

  • nausea and vomiting

    2 days

  • thirst sensation on verbal rating scale

    2 days

  • hunger sensation on verbal rating scale

    2 days

  • +2 more secondary outcomes

Study Arms (2)

Control

SHAM COMPARATOR

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

Other: free water only

Carbohydrate

EXPERIMENTAL

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

Interventions

carbohydrate oral intakeDIETARY_SUPPLEMENT

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)

Carbohydrate
free water onlyOTHER

Women will have free access to water only

Control

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsnullparous pregnant women during labor and delivery
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • nulliparous women
  • singleton pregnancy
  • social insurance
  • uncomplicated pregnancy
  • no contraindication to vaginal delivery

You may not qualify if:

  • scheduled caesarean section
  • labor \< 37 weeks of gestational age
  • scheduled induced delivery
  • contraindication to pushing effort during labor and delivery
  • BMI \> 40 kg/m2
  • medical history of diabetes mellitus, hypertension, heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caen University Hospital

Caen, France

RECRUITING

Study Officials

  • jean-luc hanouz, M.D., Ph.D.

    University Hospital of Caen

    STUDY CHAIR

Central Study Contacts

jean-luc hanouz

CONTACT

33 2 31 06 47 36hanouz-jl@chu-caen.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor (i.e. obstetrician) will be unaware of group allocation
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: controlled and monitored oral fruit juice intake in order to achieve an oral calory intake \> 44kCal/hour during labor
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2021

First Posted

October 15, 2021

Study Start

February 11, 2022

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

September 3, 2028

Last Updated

July 25, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)