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

Pregnancy Related Clinical Trial

— soliso-2  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05080309
• Other study ID #: 21-0017
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: September 3, 2022

Study information

• Verified date: June 2021
• Source: University Hospital, Caen
• Contact: jean-luc hanouz
• Phone: 33 2 31 06 47 36
• Email: hanouz-jl[@]chu-caen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Following Siliso study we found a trend toward a decrease in instrumental vaginal delivery and the mount of carbohydrate intake durong 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: September 3, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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 daibetes mellitus, hypertension, heart disease

Related Conditions & MeSH terms

• Delivery Complication
• Labor Long
• Pregnancy Related

Intervention

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)

Other:
• free water only
Women will have free access to water only

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	instrumental vaginal delivery	rate of instrumental vaginal delivery	2 days
Secondary	oxytocin administration	rate of oxytocin administration	2 days
Secondary	caesarean section	rate of caesarean section	2 days
Secondary	nausea and vomiting	rate of nausea and vomiting	2 days
Secondary	thirst sensation on verbal rating scale	self evaluation of thirst using a verbal rating scale from 0 (not thirst to 10 maximal thirst)	2 days
Secondary	hunger sensation on verbal rating scale	self evaluation of hunge rusing a verbal rating scale from 0 (no hunger to 10 maximal hunger)	2 days
Secondary	fatigue	self evaluation of fatigue using a verbal rating scale from 0 (0 no fatigue to 10 exhausted)	2 days
Secondary	umbilical blood pH	umbilical blood pH measured at child birth	1 min