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

Part of paid clinical trials in Norfolk, Virginia.

Sponsor
Eastern Virginia Medical School
Study ID
NCT07124130
Phase
PHASE4
Status
Recruiting

Conditions

  • Induced Labor

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Sep 30, 2025
Status verified
Aug 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
158 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Sentara Norfolk General HospitalNorfolkVirginia23507
Tetsuya Kawakita, MD
757-446-7900

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