Effects of Rate and/or Presence of Dextrose on the Labor Course of Nulliparas
NCT ID: NCT01904617
Last Updated: 2015-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
300 participants
INTERVENTIONAL
2013-04-30
2014-04-30
Brief Summary
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Detailed Description
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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:
1. 5% dextrose Normal saline (Normal saline plus 5g/dl of glucose) at 125 mL/hr (the current LBMMC default inpatient IV order set)
2. Normal saline (a solution containing sodium and chloride) at 250 mL/hr
3. 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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D5NS at 125 mL/hr
5% dextrose in normal saline at 125 mL/hr
Dextrose
Normal Saline
D2.5NS at 250mL/hr
2.5% dextrose in normal saline at 250 mL/hr
Dextrose
Normal Saline
NS at 250mL/hr
Normal saline at 250mL/hr
Normal Saline
Interventions
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Dextrose
Normal Saline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
FEMALE
Yes
Sponsors
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MemorialCare Health System
OTHER
Responsible Party
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Principal Investigators
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Vineet Shrivastava, MD
Role: PRINCIPAL_INVESTIGATOR
Long Beach Memorial Medical Center
Locations
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Long Beach Memorial Medical Center
Long Beach, California, United States
Countries
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Other Identifiers
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025-11
Identifier Type: -
Identifier Source: org_study_id
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