RecruitingPhase 4NCT07124130

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

Parenteral Lactated Ringer's Plus Dextrose 5% vs Lactated Ringer's in Labor: A Randomized Control Trial on Maternal and Neonatal Outcomes


Sponsor

Eastern Virginia Medical School

Enrollment

158 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria6

  • 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 ≤ 6)

Exclusion Criteria13

  • 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 membraned
  • Favorable cervix (Bishop score >6)
  • 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 (>38.0 degrees Celsius)
  • Stillbirth
  • Planned cesarean delivery
  • Women presenting with emergent circumstances for labor induction

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Interventions

DRUG5% Dextrose (D5) in Normal Saline (NS)

A solution of 5% dextrose and lactate ringer will be given to one group of participants.

DRUGLactate Ringer

A Lactate Ringer solution will be given to one group of participants.


Locations(2)

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Policlinico di Modena

Modena, Italy

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NCT07124130