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

Eastern Virginia Medical School (EVMS)

Status and phase: Enrolling; Phase 4

Conditions: Induced Labor

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07124130

25-03-FB-0052

Details and patient eligibility

About

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.

Enrollment: 158 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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158 participants in 2 patient groups

5% dextrose and Lactate Ringer

Active Comparator group

Description:

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

Treatment:

Drug: Lactate Ringer

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

Lactate Ringer only

Active Comparator group

Description:

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

Treatment:

Drug: Lactate Ringer