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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01904617
Enrollment
300
Registered
2013-07-22
Start date
2013-04-30
Completion date
2014-04-30
Last updated
2015-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intravenous Hydration of Labor, Length of Labor, Second Stage of Labor

Keywords

Length of labor, second stage of labor, intravenous hydration of labor, intravenous glucose

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.

Interventions

OTHERDextrose
OTHERNormal Saline

Sponsors

MemorialCare Health System
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Length of laborTime from fluid initiation to delivery

Secondary

MeasureTime frame
Time of second stage of laborTime from initiation of pushing to delivery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026