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OpenTrials
Completed

NCT Number: NCT01904617

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

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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Long Beach Memorial Medical Center

Long Beach, California, 90806, United States

About this study

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:

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

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Dextrose

Other

Normal Saline

Other

Other names: Intravenous fluids, normal saline

Primary outcomes

  1. Length of labor

    Time frame: Time from fluid initiation to delivery

Secondary outcomes

  1. Time of second stage of labor

    Time frame: Time from initiation of pushing to delivery

Sponsors and collaborators

Lead sponsor

MemorialCare Health System

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 22, 2013
Registry last updated
Jan 8, 2015

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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