NCT07124130 Lactated Ringer's and Dextrose 5% vs Only Lactated Ringer's in Labor
| NCT ID | NCT07124130 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Eastern Virginia Medical School |
| Condition | Induced Labor |
| Study Type | INTERVENTIONAL |
| Enrollment | 158 participants |
| Start Date | 2025-09 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 158 participants in total. It began in 2025-09 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07124130 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Induced Labor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07124130 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07124130 currently recruiting?
Yes, NCT07124130 is actively recruiting participants. Contact the research team at kawakit@odu.edu for enrollment information.
Where is the NCT07124130 trial being conducted?
This trial is being conducted at Norfolk, United States, Modena, Italy.
Who is sponsoring the NCT07124130 clinical trial?
NCT07124130 is sponsored by Eastern Virginia Medical School. The trial plans to enroll 158 participants.