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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00569439
Recruitment Status : Completed
First Posted : December 7, 2007
Last Update Posted : December 7, 2007
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Brief Summary:
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 or disease Intervention/treatment Phase
Labor Drug: D5NS Drug: D10NS Drug: NS Phase 2

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  (Clinical Trial)
Actual Enrollment : 301 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing Normal Saline With and Without Dextrose on the Course of Labor in Nulliparas
Study Start Date : November 2000
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

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

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

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00569439

Sponsors and Collaborators
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

Responsible Party: Kenneth Chan, Memorial Care Identifier: NCT00569439     History of Changes
Other Study ID Numbers: 035-00
First Posted: December 7, 2007    Key Record Dates
Last Update Posted: December 7, 2007
Last Verified: June 2006

Keywords provided by MemorialCare:

Additional relevant MeSH terms:
Pharmaceutical Solutions