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

NCT01904617 — Not applicable, Completed, 300 participants, MemorialCare Health System

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

Registry	NCT01904617
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	300 (Actual)
Sponsor	MemorialCare Health System (Other)
Conditions	Length of Labor, Second Stage of Labor, Intravenous Hydration of Labor
Interventions	Dextrose, Normal Saline (Other)
Dates	start 2013-04-01, primary completion 2014-04-01, completion 2014-04-01, first posted 2013-07-22, last updated 2015-01-08
Locations	1 site in United States

-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

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
D5NS at 125 mL/hr	Experimental	Other: Dextrose; Other: Normal Saline	5% dextrose in normal saline at 125 mL/hr
D2.5NS at 250mL/hr	Experimental	Other: Dextrose; Other: Normal Saline	2.5% dextrose in normal saline at 250 mL/hr
NS at 250mL/hr	Experimental	Other: Normal Saline	Normal saline at 250mL/hr

Dextrose (Other)
Normal Saline (Other), also known as Intravenous fluids, normal saline

+Outcome measures

Primary outcomes

Length of labor [Time from fluid initiation to delivery]

Secondary outcomes

Time of second stage of labor [Time from initiation of pushing to delivery]

+Eligibility

Sex: Female, ages: 18 Years to 60 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Long Beach Memorial Medical Center	Long Beach, California	United States

+Investigators

Vineet Shrivastava, MD, Principal investigator, Long Beach Memorial Medical Center