NCT00569439

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
301

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2000

Longer than P75 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2000

Completed
6.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2007

Completed
Last Updated

December 7, 2007

Status Verified

June 1, 2006

First QC Date

December 6, 2007

Last Update Submit

December 6, 2007

Conditions

Labor

Keywords

LaborCarbohydrateDystocia

Outcome Measures

Primary Outcomes (1)

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

    Prospective

Secondary Outcomes (4)

  • Carbohydrate solutions can decrease the incidence of prolonged labor (> 12 hours

    Prospective

  • Carbohydrate solutions can decrease the incidence of chorioamnionitis during labor

    Prospective

  • Carbohydrate solutions can decrease the need for oxytocin (a contraction stimulant) augmentation of labor

    Prospective

  • Carbohydrate solutions can decrease the frequency of cesarean sections for prolonged labor

    Prospective

Study Arms (3)

D5

EXPERIMENTAL

5% Dextrose Solution in Normal Saline

Drug: D5NS

D10

EXPERIMENTAL
Drug: D10NS

NS

PLACEBO COMPARATOR
Drug: NS

Interventions

D5NSDRUG

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

D5
D10NSDRUG

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

D10
NSDRUG

Normal Saline solution at 125 cc/hr

NS

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dystocia

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 6, 2007

First Posted

December 7, 2007

Study Start

November 1, 2000

Study Completion

June 1, 2007

Last Updated

December 7, 2007

Record last verified: 2006-06