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Effects of Rate and/or Presence of Dextrose on the Labor Course of Nulliparas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01904617
Recruitment Status : Completed
First Posted : July 22, 2013
Last Update Posted : January 8, 2015
Sponsor:
Information provided by (Responsible Party):
MemorialCare Health System

Brief Summary:
This randomized controlled trial aims to compare three groups of intravenous fluids and their impact on labor: 1) 125 mL/hr of 5% dextrose in normal saline 2) 250 mL/hr of normal saline 3) 250 mL/hr of 5% dextrose in normal saline

Condition or disease Intervention/treatment Phase
Length of Labor Second Stage of Labor Intravenous Hydration of Labor Other: Dextrose Other: Normal Saline Not Applicable

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:

  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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial on the Effects of Rate and/or Presence of Dextrose on the Labor Course of Nulliparas
Study Start Date : April 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: D5NS at 125 mL/hr
5% dextrose in normal saline at 125 mL/hr
Other: Dextrose
Other: Normal Saline
Other Name: Intravenous fluids, normal saline

Experimental: D2.5NS at 250mL/hr
2.5% dextrose in normal saline at 250 mL/hr
Other: Dextrose
Other: Normal Saline
Other Name: Intravenous fluids, normal saline

Experimental: NS at 250mL/hr
Normal saline at 250mL/hr
Other: Normal Saline
Other Name: Intravenous fluids, normal saline




Primary Outcome Measures :
  1. Length of labor [ Time Frame: Time from fluid initiation to delivery ]

Secondary Outcome Measures :
  1. Time of second stage of labor [ Time Frame: Time from initiation of pushing to delivery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01904617


Locations
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United States, California
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
Sponsors and Collaborators
MemorialCare Health System
Investigators
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Principal Investigator: Vineet Shrivastava, MD Long Beach Memorial Medical Center
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Responsible Party: MemorialCare Health System
ClinicalTrials.gov Identifier: NCT01904617    
Other Study ID Numbers: 025-11
First Posted: July 22, 2013    Key Record Dates
Last Update Posted: January 8, 2015
Last Verified: January 2015
Keywords provided by MemorialCare Health System:
Length of labor
second stage of labor
intravenous hydration of labor
intravenous glucose