Recruiting

5% Dextrose & Lactated Ringers

Sponsor:

Eastern Virginia Medical School

Code:

NCT07124130

Conditions

Induced Labor

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Lactate Ringer

Study Details

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. 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

Induced Labor

Study ID

NCT07124130

Start date

Sep, 2025

Status verified date

Aug, 2025

Completion date

Mar, 2026

Anticipated

Primary completion date

Mar, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

158 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 5% dextrose and Lactate Ringer

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

active comparator: Lactate Ringer only

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

Interventions

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.

Primary outcome measure

  • Time from Induction Start To Delivery [ Time Frame: From enrollment to the end of labor ]

Central Contacts and Locations

Central contacts

Tetsuya Kawakita, MD

757-446-7900kawakit@odu.edu

Locations

Sentara Norfolk General Hospital

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

Tetsuya Kawakita, MD

757-446-7900kawakit@odu.edu

More Information

Sponsor

Eastern Virginia Medical School

Last update posted

Aug 22, 2025

Last verified

Aug, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eastern Virginia Medical School on 2025-08-22.