Induced Labor
Conditions
Keywords
Induced labor, 5% dextrose, Lactated Ringers, duration of labor
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.
Interventions
A solution of 5% dextrose and lactate ringer will be given to one group of participants.
DRUGLactate Ringer
A Lactate Ringer solution will be given to one group of participants.
Sponsors
University of Modena and Reggio Emilia
Eastern Virginia Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from Induction Start To Delivery | From enrollment to the end of labor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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 |
| Delivery within 12 hours of induction. | Time from induction until delivery. | Incidence of delivery within 12 hours of induction. |
| 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 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 5- minute Apgar score <7 | From time of delivery up to 1 day following delivery. | Incidence of 5-minute Apgar score\<7 |
| Arterial umbilical cord pH <7 | From time of enrollment up to 1 day following delivery. | Incidence of arterial umbilical cord pH \<7 |
| 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 |
| 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 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. |
| 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. |
| 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. |
| 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 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. |
| 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. |
| 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. |
| 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. |
| Cord Prolapse | From time of enrollment to delivery. | Occurrence of cord prolapse during labor. |
Countries
Italy, United States
Contacts
Primary ContactTetsuya Kawakita, MD
Outcome results
None listed