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

NCT ID: NCT01904617

Last Updated: 2015-01-08

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-04-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Length of Labor Second Stage of Labor Intravenous Hydration of Labor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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D5NS at 125 mL/hr

5% dextrose in normal saline at 125 mL/hr

Group Type EXPERIMENTAL

Dextrose

Intervention Type OTHER

Normal Saline

Intervention Type OTHER

D2.5NS at 250mL/hr

2.5% dextrose in normal saline at 250 mL/hr

Group Type EXPERIMENTAL

Dextrose

Intervention Type OTHER

Normal Saline

Intervention Type OTHER

NS at 250mL/hr

Normal saline at 250mL/hr

Group Type EXPERIMENTAL

Normal Saline

Intervention Type OTHER

Interventions

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Dextrose

Intervention Type OTHER

Normal Saline

Intervention Type OTHER

Other Intervention Names

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Intravenous fluids, normal saline

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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MemorialCare Health System

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Other Identifiers

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025-11

Identifier Type: -

Identifier Source: org_study_id

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