- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01904617
Effects of Rate and/or Presence of Dextrose on the Labor Course of Nulliparas
A Randomized Controlled Trial on the Effects of Rate and/or Presence of Dextrose on the Labor Course of Nulliparas
Study Overview
Status
Intervention / Treatment
Detailed Description
Currently, patients who arrive to labor and delivery automatically receive IV fluid hydration as part of a standard order set. The current default IV fluid order is 125mL/hr of 5% dextrose, either in normal saline or lactated ringers.
Any patient delivering for the first time presenting to labor and delivery in active labor will be screened. If they meet inclusion requirements they will be offered enrollment.
Subjects will be blindly randomized to receive one of three different types of IV fluids:
- 5% dextrose Normal saline (Normal saline plus 5g/dl of glucose) at 125 mL/hr (the current LBMMC default inpatient IV order set)
- Normal saline (a solution containing sodium and chloride) at 250 mL/hr
2.5% dextrose Normal saline at 125 mL/hr
- Management of labor will be at the discretion of the attending physician(s).
- Maternal outcomes to be measured include: 1) total amount of IV fluids administered, 2) length of labor, 3) epidural use, 4) oxytocin use, 5) mode of delivery, 6) development of maternal infections or other morbidity such as postpartum hemorrhage.
- Neonatal outcomes to be measured include: 1) birth weight, 2) Apgar scores, 3) hospital course (nursery placement and length of stay), 4) need for treatment of jaundice.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Long Beach, California, United States, 90806
- Long Beach Memorial Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
• Primiparous
- Singleton gestation
- Vertex presentation
- Spontaneous active labor with or without pitocin augmentation
- Gestational age > 36 weeks
- Cervical dilation 3 to 5 cm with or without ruptured membranes
Exclusion Criteria:
• Multiparous
- Pregestational or gestational diabetes mellitus
- Preeclampsia at admission
- Previous cesarean section
- Non-vertex presentation
- Multiple gestation
- Chorioamnionitis at admission
- Intrauterine growth restriction (< 10th percentile)
- Patients admitted for induction
- BMI > 50
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: D5NS at 125 mL/hr
5% dextrose in normal saline at 125 mL/hr
|
Other Names:
|
Experimental: D2.5NS at 250mL/hr
2.5% dextrose in normal saline at 250 mL/hr
|
Other Names:
|
Experimental: NS at 250mL/hr
Normal saline at 250mL/hr
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Length of labor
Time Frame: Time from fluid initiation to delivery
|
Time from fluid initiation to delivery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time of second stage of labor
Time Frame: Time from initiation of pushing to delivery
|
Time from initiation of pushing to delivery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Vineet Shrivastava, MD, Long Beach Memorial Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 025-11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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