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

MemorialCare Health System

Status: Completed

Conditions: Second Stage of Labor; Length of Labor; Intravenous Hydration of Labor

Treatments: Other: Dextrose; Other: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01904617

025-11

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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300 participants in 3 patient groups

D5NS at 125 mL/hr

Experimental group

Description:

5% dextrose in normal saline at 125 mL/hr

Treatment:

Other: Normal Saline

Other: Dextrose

D2.5NS at 250mL/hr

Experimental group

Description:

2.5% dextrose in normal saline at 250 mL/hr

Treatment:

Other: Normal Saline

Other: Dextrose

NS at 250mL/hr

Experimental group

Description:

Normal saline at 250mL/hr

Treatment:

Other: Normal Saline