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

Not Applicable

Completed

• Conditions: Length of Labor; Intravenous Hydration of Labor; Second Stage of Labor
• Interventions: Other: Dextrose; Other: Normal Saline

• Registration Number: NCT01904617
• Lead Sponsor: MemorialCare Health System

Brief 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

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 Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-19
• Study First Submitted QC: 2013-07-17
• Study First Posted: 2013-07-22
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-07
• Last Update Posted: 2015-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
D5NS at 125 mL/hr	Dextrose	5% dextrose in normal saline at 125 mL/hr
D5NS at 125 mL/hr	Normal Saline	5% dextrose in normal saline at 125 mL/hr
D2.5NS at 250mL/hr	Normal Saline	2.5% dextrose in normal saline at 250 mL/hr
NS at 250mL/hr	Normal Saline	Normal saline at 250mL/hr
D2.5NS at 250mL/hr	Dextrose	2.5% dextrose in normal saline at 250 mL/hr

Primary Outcome Measures

Name	Time	Method
Length of labor	Time from fluid initiation to delivery

Secondary Outcome Measures

Name	Time	Method
Time of second stage of labor	Time from initiation of pushing to delivery

Trial Locations

Locations (1)

Long Beach Memorial Medical Center; 🇺🇸 Long Beach, California, United States