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

Not Applicable

Recruiting

• Conditions: Induced Labor
• Interventions: Drug: 5% Dextrose (D5) in Normal Saline (NS); Drug: Lactate Ringer

• Registration Number: NCT07124130
• Lead Sponsor: Eastern Virginia Medical School

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-22
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-08
• Study First Posted: 2025-08-15
• Last Update Submitted: 2025-08-18
• Last Update Posted: 2025-08-22
• Study Start: 2025-09-01
• Primary Completion: 2026-03
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 158

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5% dextrose and Lactate Ringer	5% Dextrose (D5) in Normal Saline (NS)	Participants randomized to this arm will receive an intravenous solution of 5% dextrose and Lactate Ringer during labor.
5% dextrose and Lactate Ringer	Lactate Ringer	Participants randomized to this arm will receive an intravenous solution of 5% dextrose and Lactate Ringer during labor.
Lactate Ringer only	Lactate Ringer	Participants randomized to this arm will receive an intravenous Lactate Ringer solution only.

Primary Outcome Measures

Name	Time	Method
Time from Induction Start To Delivery	From enrollment to the end of labor

Secondary Outcome Measures

Name	Time	Method
Type of amniotomy	From enrollment until delivery	Spontaneous vs artificial
Mode of Delivery	From enrollment until delivery.	The incidence of spontaneous vaginal delivery, operative vaginal delivery and cesarean delivery.
Indication for cesarean delivery	From enrollment until delivery.	Rate of failed induction of labor, arrest of active phase, arrest of descent, non-reassuring fetal condition, maternal request, other.
Delivery within 12 hours of induction.	Time from induction until delivery.	Incidence of delivery within 12 hours of induction.
Delivery within 24 hours of Induction	Time of induction to time of delivery.	Incidence of delivery within 24 hours of induction.
Delivery within 36 hours of Induction	From time of induction to time of delivery.	Incidence of delivery within 36 hours of induction.
Delivery within 48 hours of Induction	From time of induction to time of delivery.	Incidence of delivery within 48 hours of induction.
Perineal Lacerations (Degree I-IV)	From time of enrollment to time of delivery.	Degree of perineal lacerations occurring during delivery (first to fourth degree).
Postpartum hemorrhage	Time of enrollment to time of delivery.	Blood loss \>1000 mL
Blood Transfusion	From time of enrollment to hospital discharge (up to 42 days post-delivery).	Incidence of blood transfusions required during or after delivery.
Isolated maternal fever	From time of enrollment to hospital discharge (up to 42 days post-delivery).	Incidence of maternal fever (T\>38°C)
Diagnosed Endometritis	From time of enrollment to hospital discharge (up to 42 days post-delivery).	The number of endometritis based on clinical signs and diagnostic tests.
Wound Separation/Infection	From time of enrollment to hospital discharge (up to 42 days post-delivery).	Incidence of wound separation or infection requiring additional closure or antibiotics.
Intraamniotic Infection	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.
Venous Thromboembolism (VTE)	From time of enrollment to hospital discharge (up to 42 days post-delivery).	Occurrence of venous thromboembolism.
Hysterectomy	From time of enrollment to hospital discharge (up to 42 days post-delivery).	Occurrence of hysterectomy related to delivery complications.
Intensive Care Unit (ICU) Admission	From time of enrollment to ICU admission (up to 42 days post-delivery).	Admission to ICU for maternal complications.
Maternal Death	From time of enrollment until maternal death (up to 42 days post-delivery).	Occurrence of maternal death during or after delivery.
Length of hospital stay	From time of hospital admission to time of hospital discharge (up to 50 days post-delivery).	Days between admission and discharge
Cord Prolapse	From time of enrollment to delivery.	Occurrence of cord prolapse during labor.
Use of Terbutaline	From time of enrollment to delivery.	The number of terbutaline use for uterine contractions.
Placement of Intrauterine Pressure Catheter	From time of enrollment to delivery.	The number of placement of intrauterine pressure catheter during labor.
Epidural Use	From time of enrollment to delivery.	Use of epidural anesthesia during labor for pain relief.
Neonatal 5- minute Apgar score <7	From time of delivery up to 1 day following delivery.	Incidence of 5-minute Apgar score\<7
Neonatal Intensive Care Unit (NICU) Admission	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.
Neonatal Head Cooling Therapy	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.
Neonatal Length of Stay (days)	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.
Neonatal Severe Respiratory Distress Syndrome (RDS)	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.
Neonatal outcome composite	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
Hypoxic-Ischemic Encephalopathy	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.
Neonatal Intraventricular Hemorrhage (Grade 3 or 4)	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.
Arterial umbilical cord pH <7	From time of enrollment up to 1 day following delivery.	Incidence of arterial umbilical cord pH \<7
Diagnosed Neonatal Necrotizing Enterocolitis	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.
NICU Stay >48 hours	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.
Bishop Score: Cervical Dilation, Effacement, Station, Position, Consistency	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.
Neonatal Sepsis (Culture-proven or Presumed)	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.
Neonatal Blood Transfusion	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.

Trial Locations

Locations (2)

Sentara Norfolk General Hospital; 🇺🇸 Norfolk, Virginia, United States

Policlinico di Modena; 🇮🇹 Modena, Italy