A Study on the Effects of Dextrose Solutions on the Course of Labor

A Randomized Controlled Trial Comparing Normal Saline With and Without Dextrose on the Course of Labor in Nulliparas

The purpose is to determine in term nulliparas with singletons that present in active labor (3-5 cm) or with ruptured membranes whether the administration of dextrose solutions to normal saline improves or expedites the course of labor. The researchers' hypothesis is that the addition of a carbohydrate substrate will shorten the length of labor and facilitate a vaginal delivery.

Study Overview

• Status: Completed
• Conditions: Labor
• Intervention / Treatment: Drug: D5NS; Drug: D10NS; Drug: NS

Detailed Description

Factors that affect the course of labor have been studied extensively. Surprisingly, there is little data on the effect that different types and rates of intravenous (IV) fluids have during labor. Exercise physiologists have shown that increased fluid intake and carbohydrate replacement improve skeletal muscle performance in prolonged exercise. In a 1992 randomized, controlled study comparing IV fluid rates, Garite et al. showed a lower frequency of prolonged labor, and possibly a decreased need for oxytocin, with higher IV fluid rates in labor. Inadequate hydration may contribute to dysfunctional labor and possibly an increased rate of cesarean section.

We propose that inadequate carbohydrate replacement in labor may also contribute to prolongation of labor and increased need for operative delivery. Glucose is the main energy supply for the pregnant uterus. Physiological requirements for glucose during labor are approximately 10 grams per hour. Adequate supplies of glucose are needed to maintain exercise tolerance and muscle efficiency, which are important factors in the progress of labor. Dysfunctional labor or dystocia, which is the leading indication for primary cesarean delivery, is caused by uterine forces insufficiently strong or inappropriately coordinated to efface and dilate the cervix. Dystocia can also be a result of inadequate voluntary muscle effort in the second stage of labor. It contributes to increased risk for chorioamnionitis, which is a leading cause of maternal and fetal morbidity and mortality. Supplying carbohydrate fuel for working uterine and skeletal muscle may improve progress in labor and, therefore, diminish risk for chorioamnionitis and need for cesarean delivery.

• Study Type: Interventional
• Enrollment (Actual): 301
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

• Primiparous
• Singleton gestation
• Vertex presentation
• Spontaneous active labor with or without pitocin augmentation
• Gestational age > 36 weeks
• Cervical dilation 3 to 5 cm with or without ruptured membranes

Exclusion Criteria:

• Multiparous
• Pregestational or gestational diabetes mellitus
• Preeclampsia at admission
• Previous cesarean section
• Non-vertex presentation
• Multiple gestation
• Chorioamnionitis at admission
• Intrauterine growth restriction (< 10th percentile)
• Patients admitted for induction

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: D5; 5% Dextrose Solution in Normal Saline	Drug: D5NS; 5% Dextrose in Normal Saline (6.25 gr/hr) at 125 cc/hr
Experimental: D10	Drug: D10NS; 10% Dextrose Solution (12.5 gr/h) in Normal Saline at 125 cc/hr
Placebo Comparator: NS	Drug: NS; Normal Saline solution at 125 cc/hr

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Carbohydrate solutions can decrease the total duration of labor by 20% (from 560 minutes to 450 minutes)	Prospective

Secondary Outcome Measures

Outcome Measure	Time Frame
Carbohydrate solutions can decrease the incidence of prolonged labor (> 12 hours	Prospective
Carbohydrate solutions can decrease the incidence of chorioamnionitis during labor	Prospective
Carbohydrate solutions can decrease the need for oxytocin (a contraction stimulant) augmentation of labor	Prospective
Carbohydrate solutions can decrease the frequency of cesarean sections for prolonged labor	Prospective

Collaborators and Investigators

• Sponsor: MemorialCare
• Investigators: Principal Investigator: Kenneth Chan, M.D., Memorial Care; Principal Investigator: Sherri Jenkins, M.D., University of Alabama At Birmingham; Principal Investigator: Thomas J. Garite, M.D., University of California, Irvine

Study record dates

Study Major Dates

• Study Start: November 1, 2000
• Primary Completion: December 7, 2022
• Study Completion (Actual): June 1, 2007

Study Registration Dates

• First Submitted: December 6, 2007
• First Submitted That Met QC Criteria: December 6, 2007
• First Posted (Estimate): December 7, 2007

Study Record Updates

• Last Update Posted (Estimate): December 7, 2007
• Last Update Submitted That Met QC Criteria: December 6, 2007
• Last Verified: June 1, 2006

More Information

Terms related to this study

• Keywords: Labor; Carbohydrate; Dystocia
• Other Study ID Numbers: 035-00

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No