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

NCT07124130 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 25-03-FB-0052
• Study Type: interventional
• Target: 158
• Locations: 2 countries
• Sites: 2

Brief 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. 1.Does the use of 5% dextrose and Lactated Ringers lead to a shorter labor than the use of just Lactated Ringers?
2. 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

Induced Labor

Keywords

Induced labor; 5% dextrose; Lactated Ringers; duration of labor

Outcome Measures

Primary Outcomes (1)

• Time from Induction Start To Delivery

  From enrollment to the end of labor

Secondary Outcomes (37)

• Type of amniotomy

  From enrollment until delivery

• Mode of Delivery

  From enrollment until delivery.

• Indication for cesarean delivery

  From enrollment until delivery.

• Delivery within 12 hours of induction.

  Time from induction until delivery.

• Delivery within 24 hours of Induction

  Time of induction to time of delivery.

Study Arms (2)

5% dextrose and Lactate Ringer

ACTIVE COMPARATOR

Participants randomized to this arm will receive an intravenous solution of 5% dextrose and Lactate Ringer during labor.

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

Lactate Ringer only

ACTIVE COMPARATOR

Participants randomized to this arm will receive an intravenous Lactate Ringer solution only.

Drug: Lactate Ringer

Interventions

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

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

5% dextrose and Lactate Ringer

Lactate Ringer DRUG

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

5% dextrose and Lactate Ringer; Lactate Ringer only

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Eastern Virginia Medical School: lead
• University of Modena and Reggio Emilia: collaborator

Study Sites (2)

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

RECRUITING

Policlinico di Modena

Modena, Italy

RECRUITING

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MeSH Terms

Interventions

Glucose; Ringer's Lactate

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Tetsuya Kawakita, MD

CONTACT

757-446-7900; kawakit@odu.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: August 15, 2025
• Study Start: September 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); IT (1)