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

Study Overview
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Brief Summary
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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
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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: 5% dextrose Normal saline (Normal saline plus 5g/dl of glucose) at 125 mL/hr (the current LBMMC default inpatient IV order set) Normal saline (a solution containing sodium and chloride) at 250 mL/hr 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.

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

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

Intervention / Treatment
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* Other: Dextrose
* Other: Normal Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: D5NS at 125 mL/hr<br>5% dextrose in normal saline at 125 mL/hr | Other: Dextrose<br> <br> Other: Normal Saline<br> <br> * Other names: Intravenous fluids, normal saline;|
| Experimental: D2.5NS at 250mL/hr<br>2.5% dextrose in normal saline at 250 mL/hr | Other: Dextrose<br> <br> Other: Normal Saline<br> <br> * Other names: Intravenous fluids, normal saline;|
| Experimental: NS at 250mL/hr<br>Normal saline at 250mL/hr | Other: Normal Saline<br> <br> * Other names: Intravenous fluids, normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of labor |  | Time from fluid initiation to delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of second stage of labor |  | Time from initiation of pushing to delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Length of labor, second stage of labor, intravenous hydration of labor, intravenous glucose