NCT01110005

A Trial of Intravenous Fluids During Labor

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 318 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

Detailed 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), 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.

Conditions

• Ketosis

Interventions

Type	Name	Description
OTHER	D5 Lactated Ringer's Solution (D5LR)	D5LR IV fluid
OTHER	Lactated Ringer's Solution (LR)	LR IV fluid

Timeline

• Start date: 2010-04-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2010-04-23
• Last updated: 2024-01-19
• Results posted: 2017-03-14

Locations

4 sites across 1 country: United States