NCT01904617

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 22, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

January 8, 2015

Status Verified

January 1, 2015

Enrollment Period

1 year

First QC Date

April 19, 2013

Last Update Submit

January 7, 2015

Conditions

Length of LaborSecond Stage of LaborIntravenous Hydration of Labor

Keywords

Length of laborsecond stage of laborintravenous hydration of laborintravenous glucose

Outcome Measures

Primary Outcomes (1)

  • Length of labor

    Time from fluid initiation to delivery

Secondary Outcomes (1)

  • Time of second stage of labor

    Time from initiation of pushing to delivery

Study Arms (3)

D5NS at 125 mL/hr

EXPERIMENTAL

5% dextrose in normal saline at 125 mL/hr

Other: DextroseOther: Normal Saline

D2.5NS at 250mL/hr

EXPERIMENTAL

2.5% dextrose in normal saline at 250 mL/hr

Other: DextroseOther: Normal Saline

NS at 250mL/hr

EXPERIMENTAL

Normal saline at 250mL/hr

Other: Normal Saline

Interventions

DextroseOTHER
D2.5NS at 250mL/hrD5NS at 125 mL/hr
Normal SalineOTHER
Also known as: Intravenous fluids, normal saline
D2.5NS at 250mL/hrD5NS at 125 mL/hrNS at 250mL/hr

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Long Beach Memorial Medical Center

Long Beach, California, 90806, United States

Location

MeSH Terms

Interventions

GlucoseSaline Solution

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Vineet Shrivastava, MD

    Long Beach Memorial Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2013

First Posted

July 22, 2013

Study Start

April 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

January 8, 2015

Record last verified: 2015-01

Locations

US(1)