A Trial of Intravenous Fluids During Labor

Study Overview
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Brief Summary
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The purpose of this study is to determine if intrapartum use of a glucose-containing solution will improve the outcomes in pregnant women and their babies.

Detailed Description
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This will be a multi-center, prospective, single-blind randomized trial of two types of IV fluids for maintenance hydration during labor. This study will be conducted at 4 sites: Reading (Reading Hospital), Allentown (Lehigh Valley), St. Luke Hospital and Hershey (Penn State College of Medicine). It will include 1524 pregnant women at ≥ 36 weeks presenting in spontaneous labor for anticipated delivery. The primary research hypothesis is that intravenous hydration during labor with a glucose-containing fluid will lead to more efficient uterine contractility and will lead to a reduction of cesarean delivery. The primary outcome measure is the occurrence of a cesarean birth during the study period. The primary analysis will use an intent-to-treat approach to examine differences between the two IV fluid treatments in the proportion of deliveries requiring cesarean section.

Official Title
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A Multi-Center, Two-Arm, Single-Blind Randomized Trial of IV Fluids During Labor

Conditions
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Ketosis

Intervention / Treatment
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* Other: D5 Lactated Ringer's Solution (D5LR)
* Other: Lactated Ringer's Solution (LR)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women of any age with a singleton gestation in spontaneous labor at greater than or equal to 36 weeks without contraindication to participation. These women will be in good health and candidates for vaginal delivery. Exclusion Criteria: Patients who are not candidates for vaginal delivery. This may be due to fetal malpresentation, prior cesarean section, multiple gestations, etc. Patients presenting for induction of labor or requiring induction upon admission. Patients presenting for scheduled cesarean section. Patients with any form of diabetes or glucose dysregulation condition. Concurrent use of steroids. Patients presenting in active labor with advanced cervical dilation (≥ 6 cm). Subjects participating in another labor and delivery related clinical trial that conflicts with this trial (as determined by the site PI).
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: D5 Lactated Ringer's solution (D5LR)<br>IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr. | Other: D5 Lactated Ringer's Solution (D5LR)<br>* D5LR IV fluid<br>|
| Active Comparator: Lactated Ringer's solution (LR)<br>Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr. | Other: Lactated Ringer's Solution (LR)<br>* LR IV fluid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-Section | Compare c-section rates between the D5LR and LR treatment groups | From onset of labor to delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxytocin Augmentation | Compare augmentation rates between the D5LR and LR treatment groups | From onset of labor to delivery | 
| Time to Delivery | Compare time to delivery between the D5LR and LR treatment groups | From onset of labor to delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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D5LR, glucose containing IV solution, LR, non glucose IV solution