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NCT Number: NCT07124130

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

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.

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Key information

Conditions

Induced Labor

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Policlinico di Modena, Modena, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Time from Induction Start To Delivery

    Time frame: From enrollment to the end of labor

Secondary outcomes

  1. Type of amniotomy

    Time frame: From enrollment until delivery

    Spontaneous vs artificial

  2. Mode of Delivery

    Time frame: From enrollment until delivery.

    The incidence of spontaneous vaginal delivery, operative vaginal delivery and cesarean delivery.

  3. Indication for cesarean delivery

    Time frame: From enrollment until delivery.

    Rate of failed induction of labor, arrest of active phase, arrest of descent, non-reassuring fetal condition, maternal request, other.

  4. Delivery within 12 hours of induction.

    Time frame: Time from induction until delivery.

    Incidence of delivery within 12 hours of induction.

  5. Delivery within 24 hours of Induction

    Time frame: Time of induction to time of delivery.

    Incidence of delivery within 24 hours of induction.

  6. Delivery within 36 hours of Induction

    Time frame: From time of induction to time of delivery.

    Incidence of delivery within 36 hours of induction.

  7. Delivery within 48 hours of Induction

    Time frame: From time of induction to time of delivery.

    Incidence of delivery within 48 hours of induction.

  8. Perineal Lacerations (Degree I-IV)

    Time frame: From time of enrollment to time of delivery.

    Degree of perineal lacerations occurring during delivery (first to fourth degree).

  9. Postpartum hemorrhage

    Time frame: Time of enrollment to time of delivery.

    Blood loss >1000 mL

  10. Blood Transfusion

    Time frame: From time of enrollment to hospital discharge (up to 42 days post-delivery).

    Incidence of blood transfusions required during or after delivery.

  11. Isolated maternal fever

    Time frame: From time of enrollment to hospital discharge (up to 42 days post-delivery).

    Incidence of maternal fever (T>38°C)

  12. Diagnosed Endometritis

    Time frame: From time of enrollment to hospital discharge (up to 42 days post-delivery).

    The number of endometritis based on clinical signs and diagnostic tests.

  13. Wound Separation/Infection

    Time frame: From time of enrollment to hospital discharge (up to 42 days post-delivery).

    Incidence of wound separation or infection requiring additional closure or antibiotics.

  14. Intraamniotic Infection

    Time frame: From time of enrollment to hospital discharge (up to 42 days post-delivery).

    Presence of maternal fever, tachycardia, and/or fundal tenderness suggesting intraamniotic infection.

  15. Venous Thromboembolism (VTE)

    Time frame: From time of enrollment to hospital discharge (up to 42 days post-delivery).

    Occurrence of venous thromboembolism.

  16. Hysterectomy

    Time frame: From time of enrollment to hospital discharge (up to 42 days post-delivery).

    Occurrence of hysterectomy related to delivery complications.

  17. Intensive Care Unit (ICU) Admission

    Time frame: From time of enrollment to ICU admission (up to 42 days post-delivery).

    Admission to ICU for maternal complications.

  18. Maternal Death

    Time frame: From time of enrollment until maternal death (up to 42 days post-delivery).

    Occurrence of maternal death during or after delivery.

  19. Length of hospital stay

    Time frame: From time of hospital admission to time of hospital discharge (up to 50 days post-delivery).

    Days between admission and discharge

  20. Cord Prolapse

    Time frame: From time of enrollment to delivery.

    Occurrence of cord prolapse during labor.

  21. Use of Terbutaline

    Time frame: From time of enrollment to delivery.

    The number of terbutaline use for uterine contractions.

  22. Placement of Intrauterine Pressure Catheter

    Time frame: From time of enrollment to delivery.

    The number of placement of intrauterine pressure catheter during labor.

  23. Epidural Use

    Time frame: From time of enrollment to delivery.

    Use of epidural anesthesia during labor for pain relief.

  24. Neonatal Severe Respiratory Distress Syndrome (RDS)

    Time frame: From time of delivery to hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.

    Need for intubation and mechanical ventilation for ≥12 hours.

  25. Neonatal 5- minute Apgar score <7

    Time frame: From time of delivery up to 1 day following delivery.

    Incidence of 5-minute Apgar score<7

  26. Arterial umbilical cord pH <7

    Time frame: From time of enrollment up to 1 day following delivery.

    Incidence of arterial umbilical cord pH <7

  27. Neonatal outcome composite

    Time frame: From time of delivery to hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.

    Incidence of neonatal outcome composite

  28. Neonatal Sepsis (Culture-proven or Presumed)

    Time frame: From time of delivery to hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.

    Incidence of neonatal sepsis, culture-proven or presumed.

  29. Neonatal Intensive Care Unit (NICU) Admission

    Time frame: From time of delivery to NICU admission. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.

    Admission of neonate to NICU.

  30. Hypoxic-Ischemic Encephalopathy

    Time frame: From time of delivery to hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.

    Diagnosis of hypoxic-ischemic encephalopathy in neonates.

  31. Neonatal Intraventricular Hemorrhage (Grade 3 or 4)

    Time frame: From time of enrollment to hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.

    Occurrence of grade 3 or 4 intraventricular hemorrhage in neonates.

  32. Diagnosed Neonatal Necrotizing Enterocolitis

    Time frame: From time of delivery to time of hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.

    The number of diagnosis of necrotizing enterocolitis in the neonate.

  33. Neonatal Head Cooling Therapy

    Time frame: From time of delivery to time of hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.

    Use of head cooling therapy for neonates to prevent brain injury.

  34. Neonatal Blood Transfusion

    Time frame: From time of delivery to time of hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.

    Need for blood transfusion in the neonate.

  35. NICU Stay >48 hours

    Time frame: From NICU admission to NICU discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.

    Incidence of NICU stay lasting longer than 48 hours.

  36. Neonatal Length of Stay (days)

    Time frame: From time of delivery to time of hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.

    Total length of neonatal stay in the hospital.

  37. Bishop Score: Cervical Dilation, Effacement, Station, Position, Consistency

    Time frame: From time of enrollment to time of induction up to 1 week.

    Baseline Bishop score (0-13, with 13 being more favorable to labor) and its changes during labor to assess cervical readiness for induction.

Study contacts

Contact information is provided by the study sponsor or research team.

Tetsuya Kawakita, MD

CONTACT

[email protected]

757-446-7900

Sponsors and collaborators

Lead sponsor

Eastern Virginia Medical School

Other

Collaborators

  • University of Modena and Reggio Emilia

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 15, 2025
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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