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

Study Overview
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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. 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.

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

Conditions
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Delivery Complication, Labor Long, Pregnancy Related

Intervention / Treatment
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* Dietary Supplement: carbohydrate oral intake
* Other: free water only


Participation Criteria
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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 daibetes mellitus, hypertension, heart disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: controlled and monitored oral fruit juice intake in order to achieve an oral calory intake > 44kCal/hour during labor
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control<br>During labor the women will have free access to water only but not fruit juice or other calory source. | Other: free water only<br>* Women will have free access to water only<br>|
| Experimental: Carbohydrate<br>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<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| instrumental vaginal delivery | rate of instrumental vaginal delivery | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxytocin administration | rate of oxytocin administration | 2 days | 
| caesarean section | rate of caesarean section | 2 days | 
| nausea and vomiting | rate of nausea and vomiting | 2 days | 
| 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 | 
| 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 | 
| fatigue | self evaluation of fatigue using a verbal rating scale from 0 (0 no fatigue to 10 exhausted) | 2 days | 
| umbilical blood pH | umbilical blood pH measured at child birth | 1 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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labor, intrumental vaginal delivery, oral intake, nulliparous