Lactated Ringer's + Dextrose for Induction of Labour

Recruiting at 1 trial location

Overseen By Tetsuya Kawakita, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Eastern Virginia Medical School

Disqualifiers: Diabetes, Kidney disease, Chorioamnionitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Duration of labor

158 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which IV fluid better initiates labor in pregnant women: a mix of 5% dextrose with Lactated Ringer's or just Lactated Ringer's. The researchers aim to assess whether the combination shortens labor and affects the baby's blood sugar levels. Participants will be randomly divided into two groups, each receiving one of the fluids. The trial seeks first-time mothers with a single baby in a head-down position who are at full term and have not started labor naturally. As a Phase 4 trial, this study involves an FDA-approved treatment and seeks to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for these treatments?

Research has shown that both Lactated Ringer's solution and a mix of 5% dextrose with Lactated Ringer's are generally safe during labor. These fluids are commonly used to maintain hydration and blood pressure. Studies have found that the combination of 5% dextrose and Lactated Ringer's can shorten labor without increasing the likelihood of a C-section, with most patients tolerating it well and no significant rise in side effects. Lactated Ringer's alone is also widely used and considered safe, potentially reducing the need for interventions like oxytocin, a hormone used to induce labor. Both treatments are common in hospitals, and any side effects are usually mild, such as minor swelling at the IV site or slight changes in blood sugar levels, which are rare and generally not serious. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using Lactated Ringer's with 5% dextrose for inducing labor because this combination could provide enhanced energy support to the mother during labor. Unlike traditional options, such as oxytocin that primarily stimulate contractions, the dextrose component in this treatment acts as a quick energy source, potentially improving the mother's endurance and overall labor experience. Additionally, this approach might offer a more balanced fluid management during labor, as Lactated Ringer's helps maintain proper electrolyte levels. These features make this treatment a promising alternative to standard labor induction methods.

What evidence suggests that this trial's treatments could be effective for inducing labor?

Research has shown that adding a small amount of sugar (5% dextrose) to a common IV fluid called Lactated Ringer's can shorten labor. In this trial, one group will receive these sugar-added fluids during labor, which have been associated with shorter labors on average compared to those who do not receive them. However, these fluids do not reduce the likelihood of needing a cesarean section. Another group will receive Lactated Ringer's alone, which studies have also shown can help shorten labor. The trial aims to determine whether adding sugar to Lactated Ringer's can shorten labor without increasing risks like low blood sugar in newborns. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for pregnant women undergoing labor induction. Specific eligibility criteria are not provided, but typically participants would be those in good health and without conditions that could complicate labor or affect the study outcomes.

Inclusion Criteria

Singleton pregnancy at term

I am 18 or older and can give my consent.

My cervix is not yet ready for childbirth (Bishop score ≤ 6).

Exclusion Criteria

I have a kidney condition affecting its structure.

Involuntarily confined or detained

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either 5% dextrose and Lactated Ringers or Lactated Ringers alone during labor

Duration of labor

Continuous monitoring during labor

Follow-up

Participants and neonates are monitored for safety and effectiveness after delivery

Up to 42 days post-delivery for maternal outcomes, up to 1 year for neonatal outcomes

What Are the Treatments Tested in This Trial?

Interventions

• Lactated Ringer's
• Lactated Ringer's and Dextrose 5%

Trial Overview

The trial is testing whether a combination of 5% dextrose (D5) with Lactated Ringers solution improves labor outcomes compared to using just Lactated Ringers. Participants will be randomly assigned to one of these two groups to see which method leads to shorter labor and assess the risk of neonatal hypoglycemia.

How Is the Trial Designed?

Group I: 5% dextrose and Lactate Ringer Active Control 2 Interventions

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

Group II: Lactate Ringer only Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Eastern Virginia Medical School

Lead Sponsor

Trials

77

Recruited

16,500+

University of Modena and Reggio Emilia, Italy

Collaborator

University of Modena and Reggio Emilia

Collaborator

Trials

99

Recruited

33,800+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07124130

NCT07124130 | Lactated Ringer's and Dextrose 5% vs ...

Researchers will compare the outcomes of the two groups to see which IV fluid is more effective. Official Title. Parenteral Lactated Ringer's Plus Dextrose 5% ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/23780639/

Intravenous fluids for reducing the duration of labour in low ...

For women delivering vaginally, there was a reduction in the duration of labour in the Ringer's lactate group (mean difference (MD) -28.86 ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5338473/

A multi-center randomized trial of two different intravenous ...

The use of intravenous fluid containing 5% dextrose does not lower the chance of cesarean delivery for women admitted in active labor.

4.

evidencebasedbirth.com

evidencebasedbirth.com/iv-fluids-during-labor/

Evidence on: IV Fluids during Labor

The study found that people receiving IV fluids with dextrose had significantly shorter labors, on average, compared to the other groups. The ...

5.

journal.barpetaogs.co.in

journal.barpetaogs.co.in/pdf/9924114.pdf

A prospective randomized trial to find out the effect of 5 ...

The results of the present study shows that 5% dextrose addition to normal saline for intra-partum intravenous hydration of spontaneously ...

6.

ajog.org

ajog.org/article/S0002-9378(23)00081-9/fulltext

Methods for the induction of labor: efficacy and safety

According to the National Center for Health Statistics, the overall rate of labor induction was 31.4% in 2020 compared to 27.1% in 2018 and 9.6 ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37994865/

Intravenous Ringer's lactate versus usual care during labor ...

Conclusion: IV Ringer's lactate reduced the duration of active labor, the need for oxytocin augmentation and the prolonged labor incidence.

8.

withpower.com

withpower.com/trial/phase-4-induction-of-labour-8-2025-bc7d2

Lactated Ringer's + Dextrose for Induction of Labour

Prior Safety DataThis treatment has passed at least one previous human trial ... Ringers solution improves labor outcomes compared to using just Lactated Ringers ...