Lactated Ringer's with 5% dextrose versus Lactated Ringer's alone during induced labor
Parenteral Lactated Ringer's Plus Dextrose 5% vs Lactated Ringer's in Labor: A Randomized Control Trial on Maternal and Neonatal Outcomes
This test gives women having an induced, first-time labor either Lactated Ringer's with 5% dextrose or Lactated Ringer's alone to see which shortens labor and whether the extra sugar affects newborn blood sugar.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 158 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Eastern Virginia Medical School Academic / other |
| Locations | 2 sites (Norfolk, Virginia and 1 other locations) |
| Trial ID | NCT07124130 on ClinicalTrials.gov |
What this trial studies
This randomized trial assigns nulliparous, term women with a singleton cephalic pregnancy and an unfavorable cervix to receive either Lactated Ringer's plus 5% dextrose or Lactated Ringer's alone during induction of labor. Researchers will compare total duration of labor and rates of neonatal hypoglycemia between the two groups, along with routine maternal and neonatal safety outcomes. Participants are enrolled at two hospital sites and receive standard obstetric care in addition to the assigned IV fluid. Data collection includes labor timing, delivery outcomes, and newborn glucose measurements after birth.
Who should consider this trial
Good fit: Ideal candidates are nulliparous women aged 18 or older at term with a single baby in head-down position undergoing an induction of labor with an unfavorable cervix and without diabetes or significant kidney disease.
Not a fit: Women with diabetes, planned cesarean delivery, multiparous women, preterm pregnancies, or those with active infection or emergent indications for induction are unlikely to be helped by this protocol.
Why it matters
Potential benefit: If successful, the approach could shorten induction times for first-time mothers without increasing newborn low blood sugar.
How similar studies have performed: Small prior studies and clinical observations have suggested IV dextrose may influence labor length and neonatal glucose, but high-quality randomized data on this specific comparison are limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Norfolk, Virginia and 1 other locations
- Sentara Norfolk General Hospital — Norfolk, Virginia, United States (Recruiting)
- Policlinico di Modena — Modena, Italy (Recruiting)
Study contacts
- Study coordinator: Tetsuya Kawakita, MD
- Email: kawakit@odu.edu
- Phone: 757-446-7900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.