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Recruiting Phase 4

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

NCT07124130 · tracked via the Priya Life Science Italy tracker
Sponsor
Eastern Virginia Medical School
Phase
Phase 4
Started
2025-09
Last updated
2025-08-22

Condition(s) studied

Induced Labor

Investigational drug(s) / intervention(s)

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

5% Dextrose (D5) in Normal Saline (NS): A solution of 5% dextrose and lactate ringer will be given to one group of participants.

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

Study 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
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Time from Induction Start To Delivery — From enrollment to the end of labor

Trial sites (2)

FacilityCityRegionStatus
Sentara Norfolk General Hospital Norfolk Virginia Recruiting
Policlinico di Modena Modena Italy Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07124130 on ClinicalTrials.gov ↗ ← All trials in Italy