A Phase 4 interventional study of 5% Dextrose (D5) in Normal Saline (NS) and Lactate Ringer in Induced Labor, sponsored by Eastern Virginia Medical School. Recruiting at 2 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-22.
Sponsored by Eastern Virginia Medical School · Phase 4, Interventional, and Treatment
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:
Eastern Virginia Medical School is the lead sponsor of 56 studies on the registry; 8 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to this arm will receive an intravenous solution of 5% dextrose and Lactate Ringer during labor.
Drug: 5% Dextrose (D5) in Normal Saline (NS) · Drug: Lactate Ringer
Participants randomized to this arm will receive an intravenous Lactate Ringer solution only.
Drug: Lactate Ringer
A solution of 5% dextrose and lactate ringer will be given to one group of participants.
A Lactate Ringer solution will be given to one group of participants.
Time from Induction Start To Delivery
Time frame: From enrollment to the end of labor
Type of amniotomy
Spontaneous vs artificial
Time frame: From enrollment until delivery
Mode of Delivery
The incidence of spontaneous vaginal delivery, operative vaginal delivery and cesarean delivery.
Time frame: From enrollment until delivery.
Indication for cesarean delivery
Rate of failed induction of labor, arrest of active phase, arrest of descent, non-reassuring fetal condition, maternal request, other.
Time frame: From enrollment until delivery.
Delivery within 12 hours of induction.
Incidence of delivery within 12 hours of induction.
Time frame: Time from induction until delivery.
Delivery within 24 hours of Induction
Incidence of delivery within 24 hours of induction.
Time frame: Time of induction to time of delivery.
Delivery within 36 hours of Induction
Incidence of delivery within 36 hours of induction.
Time frame: From time of induction to time of delivery.
Delivery within 48 hours of Induction
Incidence of delivery within 48 hours of induction.
Time frame: From time of induction to time of delivery.
Perineal Lacerations (Degree I-IV)
Degree of perineal lacerations occurring during delivery (first to fourth degree).
Time frame: From time of enrollment to time of delivery.
Postpartum hemorrhage
Blood loss \>1000 mL
Time frame: Time of enrollment to time of delivery.
Blood Transfusion
Incidence of blood transfusions required during or after delivery.
Time frame: From time of enrollment to hospital discharge (up to 42 days post-delivery).
Isolated maternal fever
Incidence of maternal fever (T\>38°C)
Time frame: From time of enrollment to hospital discharge (up to 42 days post-delivery).
Diagnosed Endometritis
The number of endometritis based on clinical signs and diagnostic tests.
Time frame: From time of enrollment to hospital discharge (up to 42 days post-delivery).
Wound Separation/Infection
Incidence of wound separation or infection requiring additional closure or antibiotics.
Time frame: From time of enrollment to hospital discharge (up to 42 days post-delivery).
Intraamniotic Infection
Presence of maternal fever, tachycardia, and/or fundal tenderness suggesting intraamniotic infection.
Time frame: From time of enrollment to hospital discharge (up to 42 days post-delivery).
Venous Thromboembolism (VTE)
Occurrence of venous thromboembolism.
Time frame: From time of enrollment to hospital discharge (up to 42 days post-delivery).
Hysterectomy
Occurrence of hysterectomy related to delivery complications.
Time frame: From time of enrollment to hospital discharge (up to 42 days post-delivery).
Intensive Care Unit (ICU) Admission
Admission to ICU for maternal complications.
Time frame: From time of enrollment to ICU admission (up to 42 days post-delivery).
Maternal Death
Occurrence of maternal death during or after delivery.
Time frame: From time of enrollment until maternal death (up to 42 days post-delivery).
Length of hospital stay
Days between admission and discharge
Time frame: From time of hospital admission to time of hospital discharge (up to 50 days post-delivery).
Cord Prolapse
Occurrence of cord prolapse during labor.
Time frame: From time of enrollment to delivery.
Use of Terbutaline
The number of terbutaline use for uterine contractions.
Time frame: From time of enrollment to delivery.
Placement of Intrauterine Pressure Catheter
The number of placement of intrauterine pressure catheter during labor.
Time frame: From time of enrollment to delivery.
Epidural Use
Use of epidural anesthesia during labor for pain relief.
Time frame: From time of enrollment to delivery.
Neonatal Severe Respiratory Distress Syndrome (RDS)
Need for intubation and mechanical ventilation for ≥12 hours.
Time frame: From time of delivery to hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.
Neonatal 5- minute Apgar score <7
Incidence of 5-minute Apgar score\<7
Time frame: From time of delivery up to 1 day following delivery.
Arterial umbilical cord pH <7
Incidence of arterial umbilical cord pH \<7
Time frame: From time of enrollment up to 1 day following delivery.
Neonatal outcome composite
Incidence of 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.
Neonatal Sepsis (Culture-proven or Presumed)
Incidence of 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.
Neonatal Intensive Care Unit (NICU) Admission
Admission of neonate to NICU.
Time frame: From time of delivery to NICU admission. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.
Hypoxic-Ischemic Encephalopathy
Diagnosis of hypoxic-ischemic encephalopathy in neonates.
Time frame: From time of delivery to hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.
Neonatal Intraventricular Hemorrhage (Grade 3 or 4)
Occurrence of grade 3 or 4 intraventricular hemorrhage in neonates.
Time frame: From time of enrollment to hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.
Diagnosed Neonatal Necrotizing Enterocolitis
The number of diagnosis of necrotizing enterocolitis in the neonate.
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.
Neonatal Head Cooling Therapy
Use of head cooling therapy for neonates to prevent brain injury.
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.
Neonatal Blood Transfusion
Need for blood transfusion in the neonate.
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.
NICU Stay >48 hours
Incidence of NICU stay lasting longer than 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.
Neonatal Length of Stay (days)
Total length of neonatal stay in the hospital.
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.
Bishop Score: Cervical Dilation, Effacement, Station, Position, Consistency
Baseline Bishop score (0-13, with 13 being more favorable to labor) and its changes during labor to assess cervical readiness for induction.
Time frame: From time of enrollment to time of induction up to 1 week.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Start is estimated for Sep 2025; primary completion for Mar 2026, 6 months later.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Eastern Virginia Medical School