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NCT07124130PHASE4Recruiting

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

Eastern Virginia Medical School

Start Date

9/1/2025

Completion Date

3/1/2026

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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 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 Criteria: * 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

Interventions

DRUG

5% Dextrose (D5) in Normal Saline (NS)

DRUG

Lactate Ringer

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Conditions

Induced Labor

Locations

Sentara Norfolk General Hospital

Norfolk, Virginia 23507

United States

Policlinico di Modena

Modena,

Italy