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Clinical Trial Summary

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


Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01904617
Study type Interventional
Source MemorialCare Health System
Contact
Status Completed
Phase N/A
Start date April 2013
Completion date April 2014

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