Use of Normal Saline With or Without Dextrose During Induction of Labor in Nulliparous

Delivery Uterine Clinical Trial

— DEXTRONS  

Official title:

Utilisation parentérale de Normal Salin Avec ou Sans Dextrose Durant l'Induction du Travail Chez Les Nullipares

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02655783
• Other study ID #: 12-143
• Status: Completed
• Phase: N/A
• First received: March 4, 2015
• Last updated: October 27, 2016
• Start date: January 2013
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ministère santé et services sociaux du Québec
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to compare the effects of use of normal saline (250 cc / h), with or without dextrose supplement, on the evolution of labor in nulliparous.

Description:

There is some controversy regarding intravenous hydration of patients during labor. While the use of a fast flow of hydration appears to be recognized beneficial, the addition of glucose is less well accepted. However studies on exercise physiology clearly demonstrates improved performance of skeletal muscle by increased hydration and carbohydrate replacement during prolonged exercise. This situation is similar to the condition of the uterus in labor especially since it is now established that glucose represents its principal source of energy.

However, the effect of an additional carbohydrate intake on the evolution of labor has not been extensively studied until now, and there are several schools of thought on this subject. While some studies show that such glucose addition could reduce the total duration of labor as well as its second stage, others claim that this glucose supplement offers no benefit and may even be harmful to the fetus.

It therefore seems imperative to conduct a study to compare the use of hydration with normal saline with or without dextrose during labor, as recommended in current flow (250 cc / h). To our knowledge, this has never been done.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• nulliparous woman

• monofetal pregnancy

• delivery at term

• elective induction

• favorable cervix (Bishop score of at least 6)

• cephalic presentation

Exclusion Criteria:

• diabetes

• preeclampsia

• maternal heart disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Delivery Uterine

Intervention

Other:
• 5% dextrose
women with an elective induction of labor receive IV hydratation (250 ml/h) with a normal saline solution + 5% dextrose
• normal saline
women with an elective induction of labor receive IV hydratation (250 ml/h) with a normal saline solution

Locations

Country	Name	City	State
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2nd stage of labor		during delivery of a first baby, for an average of 5 hours	No