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

This study has been completed.
Sponsor:
Information provided by:
MemorialCare
ClinicalTrials.gov Identifier:
NCT00569439
First received: December 6, 2007
Last updated: NA
Last verified: June 2006
History: No changes posted

December 6, 2007
December 6, 2007
November 2000
Not Provided
Carbohydrate solutions can decrease the total duration of labor by 20% (from 560 minutes to 450 minutes) [ Time Frame: Prospective ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Labor
  • Drug: D5NS
    5% Dextrose in Normal Saline (6.25 gr/hr) at 125 cc/hr
  • Drug: D10NS
    10% Dextrose Solution (12.5 gr/h) in Normal Saline at 125 cc/hr
  • Drug: NS
    Normal Saline solution at 125 cc/hr
  • Experimental: D5
    5% Dextrose Solution in Normal Saline
    Intervention: Drug: D5NS
  • Experimental: D10
    Intervention: Drug: D10NS
  • Placebo Comparator: NS
    Intervention: Drug: NS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
301
June 2007
Not Provided
  • 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
Female
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00569439
035-00
No
Kenneth Chan, Memorial Care
MemorialCare
Not Provided
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
MemorialCare
June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP