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Completed

NCT Number: NCT00569439

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

D5NS

Drug

5% Dextrose in Normal Saline (6.25 gr/hr) at 125 cc/hr

D10NS

Drug

10% Dextrose Solution (12.5 gr/h) in Normal Saline at 125 cc/hr

NS

Drug

Normal Saline solution at 125 cc/hr

Primary outcomes

  1. Carbohydrate solutions can decrease the total duration of labor by 20% (from 560 minutes to 450 minutes)

    Time frame: Prospective

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

MemorialCare

Other

Registry information

Official study title

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

Important dates

Study start
2000
Study completion
2007
First posted
Dec 7, 2007
Registry last updated
Dec 7, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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