A Trial of Intravenous Fluids During Labor (RARHY)
This study is enrolling participants by invitation only.
Sponsor:
Milton S. Hershey Medical Center
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: December 20, 2012
Last verified: December 2012
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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: | May 2013 |
| Estimated 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:
- 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).
Contacts and Locations
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: | December 20, 2012 |
| 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 |
ClinicalTrials.gov processed this record on May 19, 2013