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

NCT ID: NCT05080309

Last Updated: 2025-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-11

Study Completion Date

2028-09-03

Brief Summary

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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

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Conditions

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Delivery Complication Labor Long Pregnancy Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

controlled and monitored oral fruit juice intake in order to achieve an oral calory intake \> 44kCal/hour during labor
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
The outcome assessor (i.e. obstetrician) will be unaware of group allocation

Study Groups

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Control

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

Group Type SHAM_COMPARATOR

free water only

Intervention Type OTHER

Women will have free access to water only

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)

Group Type EXPERIMENTAL

carbohydrate oral intake

Intervention Type DIETARY_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)

Interventions

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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)

Intervention Type DIETARY_SUPPLEMENT

free water only

Women will have free access to water only

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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jean-luc hanouz, M.D., Ph.D.

Role: STUDY_CHAIR

University Hospital of Caen

Locations

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Caen University Hospital

Caen, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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jean-luc hanouz

Role: CONTACT

33 2 31 06 47 36

Other Identifiers

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21-0017

Identifier Type: -

Identifier Source: org_study_id

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