A Trial of Intravenous Fluids During Labor (RARHY)

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

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.

Study Overview

• Status: Completed
• Conditions: Ketosis
• Intervention / Treatment: Other: D5 Lactated Ringer's Solution (D5LR); Other: Lactated Ringer's Solution (LR)

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.

• Study Type: Interventional
• Enrollment (Actual): 318
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 17901
      • LeHigh Valley Hospital
    • Bethlehem, Pennsylvania, United States, 18015
      • St. Luke Hospital
    • Hershey, Pennsylvania, United States, 17033
      • The Penn State University
    • Reading, Pennsylvania, United States, 19611
      • The Reading Hospital and Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Women of any age with a singleton gestation in spontaneous labor at greater than or equal to 36 weeks without contraindication to participation.
2. These women will be in good health and candidates for vaginal delivery.

Exclusion Criteria:

1. Patients who are not candidates for vaginal delivery. This may be due to fetal malpresentation, prior cesarean section, multiple gestations, etc.
2. Patients presenting for induction of labor or requiring induction upon admission.
3. Patients presenting for scheduled cesarean section.
4. Patients with any form of diabetes or glucose dysregulation condition.
5. Concurrent use of steroids.
6. Patients presenting in active labor with advanced cervical dilation (≥ 6 cm).
7. Subjects participating in another labor and delivery related clinical trial that conflicts with this trial (as determined by the site PI).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Collaborators: Lehigh Valley Hospital; St. Luke's Hospital, Pennsylvania; The Reading Hospital and Medical Center
• Investigators: Study Director: Richard S Legro, M.D., The Pennsylvania State University College of Medicine, Hershey, Pennsylvania, United States; Principal Investigator: John Smulian, M.D., Lehigh Valley Hospital, Allentown, Pennsylvania, United States

Publications and helpful links

General Publications

• Dapuzzo-Argiriou LM, Smulian JC, Rochon ML, Galdi L, Kissling JM, Schnatz PF, Gonzalez Rios A, Airoldi J, Carrillo MA, Maines J, Kunselman AR, Repke J, Legro RS. A multi-center randomized trial of two different intravenous fluids during labor. J Matern Fetal Neonatal Med. 2016;29(2):191-6. doi: 10.3109/14767058.2014.998190. Epub 2015 Sep 4.

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: April 9, 2010
• First Submitted That Met QC Criteria: April 22, 2010
• First Posted (Estimated): April 23, 2010

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: D5LR; glucose containing IV solution; LR; non glucose IV solution
• Additional Relevant MeSH Terms: Metabolic Diseases; Acid-Base Imbalance; Acidosis; Ketosis; Pharmaceutical Solutions
• Other Study ID Numbers: 32118

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO