Actively Recruiting

Phase 4
Age: 18Years +
FEMALE
NCT07124130

Lactated Ringer's and Dextrose 5% vs Only Lactated Ringer's in Labor

Led by Eastern Virginia Medical School · Updated on 2025-08-22

158

Participants Needed

2

Research Sites

25 weeks

Total Duration

On this page

Sponsors

E

Eastern Virginia Medical School

Lead Sponsor

U

University of Modena and Reggio Emilia

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this clinical trial is to determine which of two types of standard intravenous (IV) fluids (a combination of 5% dextrose and Lactated Ringers solution and Lactated Ringers solution alone) has a better influence on labor when inducing labor in pregnant women. The main questions it aims to answer are: 1. Does the use of 5% dextrose and Lactated Ringers lead to a shorter labor than the use of just Lactated Ringers? 2. Does the use of 5% dextrose and Lactated Ringers increase the risk of neonatal hypoglycemia when compared to Lactated Ringers? Participants in this trial will be randomly assigned to one of two groups: a group that receives a solution of 5% dextrose and Lactated Ringers, and a group that receives Lactated Ringers alone. Researchers will compare the outcomes of the two groups to see which IV fluid is more effective.

CONDITIONS

Official Title

Lactated Ringer's and Dextrose 5% vs Only Lactated Ringer's in Labor

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Nulliparous women
  • Age 18 years or older and able to provide informed consent
  • Singleton pregnancy at term
  • Induction of labor
  • Cephalic presentation
  • Unfavorable cervix (Bishop score 64 6)
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Involuntarily confined or detained
  • Considered as having diminished decision-making capacity
  • Spontaneous labor (cervical exam between 5-6 cm) with or without ruptured membranes
  • Favorable cervix (Bishop score �3E6)
  • Diabetes mellitus (both gestational and pre-gestational)
  • Structural renal disease
  • Acute or chronic kidney disease resulting in abnormal creatinine or proteinuria
  • Evidence of chorioamnionitis or non-reassuring fetal testing at the time of enrollment
  • Pyrexia (�3E38.0 degrees Celsius)
  • Stillbirth
  • Planned cesarean delivery
  • Women presenting with emergent circumstances for labor induction

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Sentara Norfolk General Hospital

Norfolk, Virginia, United States, 23507

Actively Recruiting

2

Policlinico di Modena

Modena, Italy

Actively Recruiting

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Research Team

T

Tetsuya Kawakita, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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