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NCT Number: NCT05080309

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

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.

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Key information

Conditions

Delivery Complication Labor Long Pregnancy Related

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Caen University Hospital

Caen, France

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

carbohydrate oral intake

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)

free water only

Other

Women will have free access to water only

Primary outcomes

  1. instrumental vaginal delivery

    Time frame: 2 days

    rate of instrumental vaginal delivery

Secondary outcomes

  1. oxytocin administration

    Time frame: 2 days

    rate of oxytocin administration

  2. caesarean section

    Time frame: 2 days

    rate of caesarean section

  3. nausea and vomiting

    Time frame: 2 days

    rate of nausea and vomiting

  4. 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)

  5. 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)

  6. fatigue

    Time frame: 2 days

    self evaluation of fatigue using a verbal rating scale from 0 (0 no fatigue to 10 exhausted)

  7. umbilical blood pH

    Time frame: 1 min

    umbilical blood pH measured at child birth

Study contacts

Contact information is provided by the study sponsor or research team.

jean-luc hanouz

CONTACT

[email protected]

33 2 31 06 47 36

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Acronym: soliso-2

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Oct 15, 2021
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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