A Study on the Effects of Dextrose Solutions on the Course of Labor - Full Text View

Sponsored by:	MemorialCare
Information provided by:	MemorialCare
ClinicalTrials.gov Identifier:	NCT00569439

Purpose

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.

Condition	Intervention	Phase
Labor	Drug: D5NS Drug: D10NS Drug: NS	Phase II

Drug Information available for: Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study
Official Title:	A Randomized Controlled Trial Comparing Normal Saline With and Without Dextrose on the Course of Labor in Nulliparas

Further study details as provided by MemorialCare:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	301
Study Start Date:	November 2000
Study Completion Date:	June 2007

Arms	Assigned Interventions
D5: Experimental 5% Dextrose Solution in Normal Saline	Drug: D5NS 5% Dextrose in Normal Saline (6.25 gr/hr) at 125 cc/hr
D10: Experimental	Drug: D10NS 10% Dextrose Solution (12.5 gr/h) in Normal Saline at 125 cc/hr
NS: Placebo Comparator	Drug: NS Normal Saline solution at 125 cc/hr

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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00569439

Sponsors and Collaborators

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

More Information

No publications provided

Responsible Party:	Memorial Care ( Kenneth Chan )
Study ID Numbers:	035-00
Study First Received:	December 6, 2007
Last Updated:	December 6, 2007
ClinicalTrials.gov Identifier:	NCT00569439 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by MemorialCare:

Labor
Carbohydrate
Dystocia

Study placed in the following topic categories:

Dystocia

ClinicalTrials.gov processed this record on May 06, 2009