Effects of Rate and/or Presence of Dextrose on the Labor Course of Nulliparas

January 7, 2015 updated by: MemorialCare Health System

A Randomized Controlled Trial on the Effects of Rate and/or Presence of Dextrose on the Labor Course of Nulliparas

This randomized controlled trial aims to compare three groups of intravenous fluids and their impact on labor: 1) 125 mL/hr of 5% dextrose in normal saline 2) 250 mL/hr of normal saline 3) 250 mL/hr of 5% dextrose in normal saline

Study Overview

Detailed Description

Currently, patients who arrive to labor and delivery automatically receive IV fluid hydration as part of a standard order set. The current default IV fluid order is 125mL/hr of 5% dextrose, either in normal saline or lactated ringers.

Any patient delivering for the first time presenting to labor and delivery in active labor will be screened. If they meet inclusion requirements they will be offered enrollment.

Subjects will be blindly randomized to receive one of three different types of IV fluids:

  1. 5% dextrose Normal saline (Normal saline plus 5g/dl of glucose) at 125 mL/hr (the current LBMMC default inpatient IV order set)
  2. Normal saline (a solution containing sodium and chloride) at 250 mL/hr
  3. 2.5% dextrose Normal saline at 125 mL/hr

    • Management of labor will be at the discretion of the attending physician(s).
    • Maternal outcomes to be measured include: 1) total amount of IV fluids administered, 2) length of labor, 3) epidural use, 4) oxytocin use, 5) mode of delivery, 6) development of maternal infections or other morbidity such as postpartum hemorrhage.
    • Neonatal outcomes to be measured include: 1) birth weight, 2) Apgar scores, 3) hospital course (nursery placement and length of stay), 4) need for treatment of jaundice.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Long Beach, California, United States, 90806
        • Long Beach Memorial Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • • 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
    • BMI > 50

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: D5NS at 125 mL/hr
5% dextrose in normal saline at 125 mL/hr
Other Names:
  • Intravenous fluids, normal saline
Experimental: D2.5NS at 250mL/hr
2.5% dextrose in normal saline at 250 mL/hr
Other Names:
  • Intravenous fluids, normal saline
Experimental: NS at 250mL/hr
Normal saline at 250mL/hr
Other Names:
  • Intravenous fluids, normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Length of labor
Time Frame: Time from fluid initiation to delivery
Time from fluid initiation to delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
Time of second stage of labor
Time Frame: Time from initiation of pushing to delivery
Time from initiation of pushing to delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Vineet Shrivastava, MD, Long Beach Memorial Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

April 19, 2013

First Submitted That Met QC Criteria

July 17, 2013

First Posted (Estimate)

July 22, 2013

Study Record Updates

Last Update Posted (Estimate)

January 8, 2015

Last Update Submitted That Met QC Criteria

January 7, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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