A Trial of Intravenous Fluids During Labor (RARHY)

This study is ongoing, but not recruiting participants.
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: June 17, 2013
Last verified: June 2013
  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 Ringers Solution (D5LR)
Other: Lactated Ringers Solution (LR)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Multi-Center, Two-Arm, Single-Blind Randomized Trial of IV Fluids During Labor

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of C-Section versus Vaginal Birth [ Time Frame: 28 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of Ketosis [ Time Frame: Outcome measure will be assessed approx 28 months. 15 women per center per month over two year enrollment and 3 months to clean data ] [ Designated as safety issue: No ]
  • Influence of Ketonuria [ Time Frame: 28 months ] [ Designated as safety issue: No ]
  • Incidence of Prolonged Labor [ Time Frame: 28 months ] [ Designated as safety issue: No ]
  • Need for Oxytocin Augmentation [ Time Frame: 28 months ] [ Designated as safety issue: No ]
  • Incidence of Operative Vaginal Delivery [ Time Frame: 28 months ] [ Designated as safety issue: No ]
  • Incidence of Chorioamnionitis [ Time Frame: 28 months ] [ Designated as safety issue: No ]
  • Indications for Cesarean Birth [ Time Frame: 28 months ] [ Designated as safety issue: No ]
  • Maternal Nausea/Vomiting in Labor [ Time Frame: 28 months ] [ Designated as safety issue: No ]
  • Reduced Umbilical Artery pH/fetal Acidemia and Increased Umbilical Arter C02/fetal hypercarbia [ Time Frame: 28 months ] [ Designated as safety issue: No ]
  • Neonatal Hypoglycemia [ Time Frame: 28 months ] [ Designated as safety issue: No ]
  • Neonatal Intensive Care Unit Admission [ Time Frame: 28 months ] [ Designated as safety issue: No ]
  • Difficulties with Initiating Breast Feeding [ Time Frame: 28 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1524
Study Start Date: April 2010
Estimated Study Completion Date: August 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: D5 Lactated Ringers solution (D5LR)
Analysis with and without adjusting (post hoc) for ketonuria for primary and secondary outcomes of interest with and without controlling for confounders as indicated.
Other: D5 Lactated Ringers Solution (D5LR)
IV fluid 125 ml/hr infusion rate
Other Name: IV fluid containing glucose
Active Comparator: Lactated Ringers solution (LR)
Analyses with and without adjusting (post-hoc) for ketonuria for primary and secondary outcomes of interest, with and without controlling for confounders as indicated.
Other: Lactated Ringers Solution (LR)
IV fluid 125 ml/hr infusion rate
Other Name: Non-Glucose containing solution

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

Genders 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

No publications provided

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
Last Updated: June 17, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Ketosis
Acidosis
Acid-Base Imbalance
Metabolic Diseases
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014