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

Not Applicable

Completed

• Conditions: Delivery Uterine
• Interventions: Other: 5% dextrose; Other: normal saline

• Registration Number: NCT02655783
• Lead Sponsor: Université de Sherbrooke

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2015-03-04
• Study First Submitted QC: 2016-01-13
• Study First Posted: 2016-01-14
• Primary Completion: 2016-03
• Study Completion: 2016-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention	5% dextrose	normal saline + 5% dextrose, 250 ml/h, until expulsion of placental
control	normal saline	normal saline, 250 ml/h, until expulsion of placental
intervention	normal saline	normal saline + 5% dextrose, 250 ml/h, until expulsion of placental

Primary Outcome Measures

Name	Time	Method
2nd stage of labor	during delivery of a first baby, for an average of 5 hours

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada