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A Trial of Intravenous Fluids During Labor (RARHY)

Primary Purpose

Ketosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
D5 Lactated Ringer's Solution (D5LR)
Lactated Ringer's Solution (LR)
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ketosis focused on measuring D5LR, glucose containing IV solution, LR, non glucose IV solution

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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).

Sites / Locations

  • Lehigh Valley Hospital
  • St. Luke Hospital
  • The Penn State University
  • The Reading Hospital and Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

D5 Lactated Ringer's solution (D5LR)

Lactated Ringer's solution (LR)

Arm Description

IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.

Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.

Outcomes

Primary Outcome Measures

C-Section
Compare c-section rates between the D5LR and LR treatment groups

Secondary Outcome Measures

Oxytocin Augmentation
Compare augmentation rates between the D5LR and LR treatment groups
Time to Delivery
Compare time to delivery between the D5LR and LR treatment groups

Full Information

First Posted
April 9, 2010
Last Updated
January 24, 2017
Sponsor
Milton S. Hershey Medical Center
Collaborators
Lehigh Valley Hospital, The Reading Hospital and Medical Center, St. Luke's Hospital, Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT01110005
Brief Title
A Trial of Intravenous Fluids During Labor
Acronym
RARHY
Official Title
A Multi-Center, Two-Arm, Single-Blind Randomized Trial of IV Fluids During Labor
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
Collaborators
Lehigh Valley Hospital, The Reading Hospital and Medical Center, St. Luke's Hospital, Pennsylvania

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ketosis
Keywords
D5LR, glucose containing IV solution, LR, non glucose IV solution

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
318 (Actual)

8. Arms, Groups, and Interventions

Arm Title
D5 Lactated Ringer's solution (D5LR)
Arm Type
Active Comparator
Arm Description
IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.
Arm Title
Lactated Ringer's solution (LR)
Arm Type
Active Comparator
Arm Description
Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.
Intervention Type
Other
Intervention Name(s)
D5 Lactated Ringer's Solution (D5LR)
Intervention Description
D5LR IV fluid
Intervention Type
Other
Intervention Name(s)
Lactated Ringer's Solution (LR)
Intervention Description
LR IV fluid
Primary Outcome Measure Information:
Title
C-Section
Description
Compare c-section rates between the D5LR and LR treatment groups
Time Frame
From onset of labor to delivery
Secondary Outcome Measure Information:
Title
Oxytocin Augmentation
Description
Compare augmentation rates between the D5LR and LR treatment groups
Time Frame
From onset of labor to delivery
Title
Time to Delivery
Description
Compare time to delivery between the D5LR and LR treatment groups
Time Frame
From onset of labor to delivery

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard S Legro, M.D.
Organizational Affiliation
The Pennsylvania State University College of Medicine, Hershey, Pennsylvania, United States
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
John Smulian, M.D.
Organizational Affiliation
Lehigh Valley Hospital, Allentown, Pennsylvania, United States
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lehigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
17901
Country
United States
Facility Name
St. Luke Hospital
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
The Penn State University
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
The Reading Hospital and Medical Center
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25758624
Citation
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.
Results Reference
derived

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A Trial of Intravenous Fluids During Labor

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