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

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

Summary

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.

Description

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

Conditions

Ketosis

Intervention

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

Location

Lehigh Valley Hospital
Allentown
Pennsylvania
United States
17901

Status

Enrolling by invitation

Source

Penn State University

Results (where available)

View Results

Links

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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