Parenteral Lactated Ringer's Plus Dextrose 5% vs Lactated Ringer's in Labor: A Randomized Control Trial on Maternal and Neonatal Outcomes

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
Virginia
Sentara Norfolk General Hospital
RECRUITING
Norfolk
Other Locations
Italy
Policlinico di Modena
RECRUITING
Modena
Contact Information
Primary
Tetsuya Kawakita, MD
kawakit@odu.edu
757-446-7900
Time Frame
Start Date: 2025-09
Estimated Completion Date: 2026-03
Participants
Target number of participants: 158
Treatments
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.
Sponsors
Leads: Eastern Virginia Medical School
Collaborators: University of Modena and Reggio Emilia, Italy

This content was sourced from clinicaltrials.gov