NCT01110005

Brief Summary

The purpose of this study is to determine if intrapartum use of a glucose-containing solution will improve the outcomes in pregnant women and their babies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
318

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2010

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2010

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 23, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
4 years until next milestone

Results Posted

Study results publicly available

March 14, 2017

Completed
Last Updated

January 19, 2024

Status Verified

January 1, 2017

Enrollment Period

2.9 years

First QC Date

April 9, 2010

Results QC Date

January 24, 2017

Last Update Submit

December 21, 2023

Conditions

Ketosis

Keywords

D5LRglucose containing IV solutionLRnon glucose IV solution

Outcome Measures

Primary Outcomes (1)

  • C-Section

    Compare c-section rates between the D5LR and LR treatment groups

    From onset of labor to delivery

Secondary Outcomes (2)

  • Oxytocin Augmentation

    From onset of labor to delivery

  • Time to Delivery

    From onset of labor to delivery

Study Arms (2)

D5 Lactated Ringer's solution (D5LR)

ACTIVE COMPARATOR

IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.

Other: D5 Lactated Ringer's Solution (D5LR)

Lactated Ringer's solution (LR)

ACTIVE COMPARATOR

Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.

Other: Lactated Ringer's Solution (LR)

Interventions

D5 Lactated Ringer's Solution (D5LR)OTHER

D5LR IV fluid

D5 Lactated Ringer's solution (D5LR)
Lactated Ringer's Solution (LR)OTHER

LR IV fluid

Lactated Ringer's solution (LR)

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Women of any age with a singleton gestation in spontaneous labor at greater than or equal to 36 weeks without contraindication to participation.
  • These women will be in good health and candidates for vaginal delivery.

You may not qualify if:

  • Patients who are not candidates for vaginal delivery. This may be due to fetal malpresentation, prior cesarean section, multiple gestations, etc.
  • Patients presenting for induction of labor or requiring induction upon admission.
  • Patients presenting for scheduled cesarean section.
  • Patients with any form of diabetes or glucose dysregulation condition.
  • Concurrent use of steroids.
  • Patients presenting in active labor with advanced cervical dilation (≥ 6 cm).
  • Subjects participating in another labor and delivery related clinical trial that conflicts with this trial (as determined by the site PI).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Lehigh Valley Hospital

Allentown, Pennsylvania, 17901, United States

Location

St. Luke Hospital

Bethlehem, Pennsylvania, 18015, United States

Location

The Penn State University

Hershey, Pennsylvania, 17033, United States

Location

The Reading Hospital and Medical Center

Reading, Pennsylvania, 19611, United States

Location

Related Publications (1)

  • Dapuzzo-Argiriou LM, Smulian JC, Rochon ML, Galdi L, Kissling JM, Schnatz PF, Gonzalez Rios A, Airoldi J, Carrillo MA, Maines J, Kunselman AR, Repke J, Legro RS. A multi-center randomized trial of two different intravenous fluids during labor. J Matern Fetal Neonatal Med. 2016;29(2):191-6. doi: 10.3109/14767058.2014.998190. Epub 2015 Sep 4.

    PMID: 25758624DERIVED

MeSH Terms

Conditions

Ketosis

Interventions

Ringer's Lactate

Condition Hierarchy (Ancestors)

AcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Richard S. Legro, M.D.
Organization
Milton S. Hershey Medical Center
rsl1@psu.edu
717-531-6210

Study Officials

  • Richard S Legro, M.D.

    The Pennsylvania State University College of Medicine, Hershey, Pennsylvania, United States

    STUDY DIRECTOR

  • John Smulian, M.D.

    Lehigh Valley Hospital, Allentown, Pennsylvania, United States

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Obstetrics and Gynecology and Public Health Sciences

Study Record Dates

First Submitted

April 9, 2010

First Posted

April 23, 2010

Study Start

April 1, 2010

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

January 19, 2024

Results First Posted

March 14, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

US(4)