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A Trial of Intravenous Fluids During Labor (RARHY)

This study has been completed.
Sponsor:
Collaborators:
Lehigh Valley Hospital
The Reading Hospital and Medical Center
St. Luke's Hospital, Pennsylvania
Information provided by (Responsible Party):
Richard S. Legro, M.D., Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01110005
First received: April 9, 2010
Last updated: January 24, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention
Ketosis
Other: D5 Lactated Ringer's Solution (D5LR)
Other: Lactated Ringer's Solution (LR)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant
Primary Purpose: Treatment
Official Title: A Multi-Center, Two-Arm, Single-Blind Randomized Trial of IV Fluids During Labor

Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • C-Section [ Time Frame: From onset of labor to delivery ]
    Compare c-section rates between the D5LR and LR treatment groups


Secondary Outcome Measures:
  • Oxytocin Augmentation [ Time Frame: From onset of labor to delivery ]
    Compare augmentation rates between the D5LR and LR treatment groups

  • Time to Delivery [ Time Frame: From onset of labor to delivery ]
    Compare time to delivery between the D5LR and LR treatment groups


Enrollment: 318
Study Start Date: April 2010
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01110005

Locations
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 17901
St. Luke Hospital
Bethlehem, Pennsylvania, United States, 18015
The Penn State University
Hershey, Pennsylvania, United States, 17033
The Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19611
Sponsors and Collaborators
Milton S. Hershey Medical Center
Lehigh Valley Hospital
The Reading Hospital and Medical Center
St. Luke's Hospital, Pennsylvania
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Richard S. Legro, M.D., Professor, Obstetrics and Gynecology and Public Health Sciences, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01110005     History of Changes
Other Study ID Numbers: 32118
Study First Received: April 9, 2010
Results First Received: January 24, 2017
Last Updated: January 24, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Milton S. Hershey Medical Center:
D5LR
glucose containing IV solution
LR
non glucose IV solution

Additional relevant MeSH terms:
Pharmaceutical Solutions

ClinicalTrials.gov processed this record on April 28, 2017