Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
FEMALE
ID05080309

Effect of Oral Carbohydrate Intake More Than 44 Kilocalories Per Hour During Labour on the Rate of Instrumental Vaginal Delivery

Led by University Hospital, Caen · Updated on 2025-07-25

600

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying whether taking in carbohydrates during labor, which is a physically demanding time, can reduce the chance of needing an instrumental vaginal delivery. This study focuses on women having their first baby with a single, uncomplicated pregnancy and no conditions that prevent vaginal delivery. The aim is to see if consuming more than 44 kilocalories per hour during labor affects delivery outcomes. Participants are randomly assigned to one of two groups. One group will only have free access to water during labor, while the other group will have free access to water and additional carbohydrate intake from commercial fruit juice bricks, each containing between 430 and 660 kcal per liter. The juice intake is measured every two hours, and women are encouraged to drink one brick every two hours. This approach helps evaluate the impact of higher calorie oral intake on labor outcomes. During the study, researchers will monitor the rate of instrumental vaginal deliveries as the primary outcome within two days of labor. They will also observe other factors such as the use of oxytocin, cesarean section rates, nausea, vomiting, thirst, hunger, fatigue, and umbilical blood pH shortly after birth. The study includes women aged 18 to 60 and tracks these measures to assess how carbohydrate intake during labor may influence delivery and maternal well-being.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 60Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Nulliparous women
  • Singleton pregnancy
  • Social insurance coverage
  • Uncomplicated pregnancy
  • No contraindication to vaginal delivery
Not Eligible

You will not qualify if you...

  • Scheduled cesarean section
  • Labor before 37 weeks of gestational age
  • Cervical dilation greater than 8 cm at inclusion
  • Scheduled induced delivery
  • Contraindication to pushing effort during labor and delivery
  • Body mass index over 40 kg/m2
  • Medical history of diabetes mellitus, hypertension, or heart disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Duration of labor

Participants receive either oral carbohydrate intake with fruit juice every 2 hours or free access to water only during labor.

Continuous monitoring during labor

Follow-up

Duration - 2 days

Participants are monitored for delivery outcomes and related measures.

1 to 2 visits within 2 days after delivery

Trial Site Locations

Total: 1 location

1

Caen University Hospital

Caen, France

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Research Team

J

jean-luc hanouz

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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