Effects of Rate and/or Presence of Dextrose on the Labor... | NCT01904617

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

NCT01904617

Sponsor

MemorialCare Health System

Status

Completed

Last Update Posted

Jan 8, 2015Estimated

Enrollment

300Actual

Phase

Not Applicable

Conditions

Length of Labor
Second Stage of Labor
Intravenous Hydration of Labor

Interventions

Dextrose
Normal Saline

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Apr 2014Actual

Completion Date

Apr 2014Actual

First Submitted Date

Apr 19, 2013

First Submission Date that Met QC Criteria

Jul 17, 2013

First Posted Date

Jul 22, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2015

Last Update Posted Date

Jan 8, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
D5NS at 125 mL/hr	Experimental	5% dextrose in normal saline at 125 mL/hr	Other: Dextrose Other: Normal Saline
D2.5NS at 250mL/hr	Experimental	2.5% dextrose in normal saline at 250 mL/hr	Other: Dextrose Other: Normal Saline
NS at 250mL/hr	Experimental	Normal saline at 250mL/hr	Other: Normal Saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dextrose	Other		D2.5NS at 250mL/hr D5NS at 125 mL/hr
Normal Saline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Length of labor		Time from fluid initiation to delivery

Secondary Outcomes

Measure	Description	Time Frame
Time of second stage of labor		Time from initiation of pushing to delivery

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vineet Shrivastava, MD	Long Beach Memorial Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Long Beach Memorial Medical Center		Long Beach	California	90806	United States

Intervention Browse Module

MeSH Terms

ID	Term
D005947	Glucose
D000077330	Saline Solution

Ancestor Terms

ID	Term
D006601	Hexoses
D009005	Monosaccharides
D000073893	Sugars
D002241	Carbohydrates
D000077324

Browse Leaves

Not provided

Browse Branches

Not provided