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

NCT ID: NCT00569439

Last Updated: 2007-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

301 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-11-30

Study Completion Date

2007-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Labor

Keywords

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Labor Carbohydrate Dystocia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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D5

5% Dextrose Solution in Normal Saline

Group Type EXPERIMENTAL

D5NS

Intervention Type DRUG

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

D10

Group Type EXPERIMENTAL

D10NS

Intervention Type DRUG

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

NS

Group Type PLACEBO_COMPARATOR

NS

Intervention Type DRUG

Normal Saline solution at 125 cc/hr

Interventions

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D5NS

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

Intervention Type DRUG

D10NS

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

Intervention Type DRUG

NS

Normal Saline solution at 125 cc/hr

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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MemorialCare

OTHER

Sponsor Role lead

Responsible Party

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Memorial Care

Principal Investigators

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Kenneth Chan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Memorial Care

Sherri Jenkins, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Thomas J. Garite, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Other Identifiers

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035-00

Identifier Type: -

Identifier Source: org_study_id