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

Second Stage of Labor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01904617
• Other study ID #: 025-11
• Status: Completed
• Phase: N/A
• First received: April 19, 2013
• Last updated: January 7, 2015
• Start date: April 2013
• Est. completion date: April 2014

Study information

• Verified date: January 2015
• Source: MemorialCare Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Intravenous Hydration of Labor
• Length of Labor
• Second Stage of Labor

Intervention

Other:
• Dextrose

• Normal Saline

Locations

Country	Name	City	State
United States	Long Beach Memorial Medical Center	Long Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
MemorialCare Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of labor		Time from fluid initiation to delivery	No
Secondary	Time of second stage of labor		Time from initiation of pushing to delivery	No