A Multi-Center, Two-Arm, Single-Blind Randomized Trial of Intravenous Fluids During Labor

2014-08-27 03:14:12 | BioPortfolio


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.


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), Hershey (Penn State College of Medicine), and York (York Hospital). 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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment




D5 Lactated Ringers Solution (D5LR), Lactated Ringers Solution (LR)


Lehigh Valley Hospital
United States


Enrolling by invitation


Penn State University

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:14:12-0400

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Medical and Biotech [MESH] Definitions

Hypertonic sodium chloride solution. A solution having an osmotic pressure greater than that of physiologic salt solution (0.9 g NaCl in 100 ml purified water).

The pressure required to prevent the passage of solvent through a semipermeable membrane that separates a pure solvent from a solution of the solvent and solute or that separates different concentrations of a solution. It is proportional to the osmolality of the solution.

Solution that is usually 10 percent glucose but may be higher. An isotonic solution of glucose is 5 percent.

The washing of the VAGINA cavity or surface with a solution. Agents or drugs can be added to the irrigation solution.

The washing of a body cavity or surface by flowing solution which is inserted and then removed. Any drug in the irrigation solution may be absorbed.

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