Clinical trial NCT01904617: Effects of Rate and/or Presence of Dextrose on the Labor Course of Nulliparas
Official title: A Randomized Controlled Trial on the Effects of Rate and/or Presence of Dextrose on the Labor Course of Nulliparas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Length of Labor
Second Stage of Labor
Intravenous Hydration of Labor
Keywords: Length of labor
second stage of labor
intravenous hydration of labor
intravenous glucose
Lead sponsor: MemorialCare Health System
Sponsor class: OTHER
First posted: 2013-07-22
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Length of labor
timeFrame: Time from fluid initiation to delivery
Secondary outcomes:
measure: Time of second stage of labor
timeFrame: Time from initiation of pushing to delivery
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Center
state: California
Study officials:
affiliation: Long Beach Memorial Medical Center
name: Vineet Shrivastava, MD
role: PRINCIPAL_INVESTIGATOR
References: