The purpose of this research is to test a new instrument, called a fetal STAN monitor, that may be used during labor to monitor the electrical activity of the baby's heart. This new instrument is designed to help the doctor determine how well the baby is doing during labor. It will be used along with the existing electronic fetal monitor used to measure the baby's heart rate and the mother's contractions during birth. The specific purpose of this research study is to see if this new instrument (fetal STAN monitor) will have an impact on newborn health.
A Randomized Trial of Fetal ECG ST Segment and T Wave Analysis as an Adjunct to Electronic Fetal Heart Rate Monitoring (STAN): Fetal ECG analysis of the ST segment (STAN) is now FDA-approved and clinically available in the United States as an adjunct for the interpretation of electronic fetal heart rate patterns. There have been a number of randomized controlled trials as well as observational studies in Europe documenting utility of this modality in terms of reducing fetal acidosis at birth, and decreasing the need for operative vaginal delivery. However, despite these endorsements, there remain concerns with the application of the technology to the United States. None of the randomized trials were performed in the United States where patient case-mix and obstetrical practice, such as the use of fetal scalp pH, differ from Europe, which may affect the impact of this technology on perinatal outcomes. Moreover, the results of the European studies are not uniformly positive. This protocol describes a randomized controlled trial of the STAN technology as an adjunct to electronic fetal heart rate monitoring versus fetal heart rate monitoring alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
11,108
The STAN monitor is a system for fetal surveillance that displays the FHR, the uterine activity and information resulting from the analysis of the ST segment of the fetal ECG.
University of Alabama - Birmingham
Birmingham, Alabama, United States
Northwestern University
Chicago, Illinois, United States
Wayne State University - Hutzel Hospital
Detroit, Michigan, United States
Columbia University
New York, New York, United States
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Case Western University
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Pittsburgh - Magee Womens Hospital
Pittsburgh, Pennsylvania, United States
Brown University
Providence, Rhode Island, United States
...and 3 more locations
Number of Participants With Primary Composite Outcome
Composite primary outcome of intrapartum fetal death, neonatal death, Apgar score \<=3 at 5 minutes, neonatal seizure, umbilical artery blood pH \<= 7.05 with base deficit \>=12 mmol/L in extra-cellular fluid, intubation for ventilation at delivery, neonatal encelphalopathy
Time frame: From Delivery through 1 month of age
Number of Intrapartum Fetal Deaths (Primary Outcome Component)
Death of the fetus during the intrapartum period.
Time frame: During labor and through delivery of the baby
Number of Neonatal Deaths (Primary Outcome Component)
Death of the newborn between delivery and1 month of age
Time frame: Delivery through1 month of age
Number of Infants With Apgar Score < = 3 at 5 Minutes (Primary Outcome Component)
The Apgar score is a simple method of quickly assessing the health and vital signs of a newborn baby created by and named after Dr. Virginia Apgar. Apgar testing assesses Appearance, Pulse, Grimace and Activity in a newborn and is typically done at one and five minutes after a baby is born, and it may be repeated at 10, 15, and 20 minutes if the score is low. The five criteria are each scored as 0, 1, or 2 (two being the best), and the total score is calculated by then adding the five values obtained. Agar scores of 0-3 are critically low, 4-6 are below normal, and indicate that the baby likely requires medical intervention, scores of 7+ are considered normal. The lower the Apgar score, the more alert the medical team should be to the possibility of the baby requiring intervention. Some components of the Apgar score are subjective, and there are cases in which a baby requires urgent medical treatment despite having a high Apgar score. The lowest score is 0, the highest score is 10.
Time frame: 5 minutes after delivery
Number of Infants Who Experienced Neonatal Seizure (Primary Outcome Component)
Number of infants who experienced Neonatal Seizure
Time frame: Birth through hospital discharge
Number of Infants With Umbilical-artery Blood pH < = 7.05 and Base Deficit in Extracellular Fluid > = 12 mmol/Liter (Primary Outcome Component)
Umbilical-artery blood pH \< = 7.05 and base deficit in extracellular fluid \> = 12 mmol/liter
Time frame: Delivery
Number of Neonates Intubated for Ventilation at Delivery (Primary Outcome Component)
Neonatal intubation for ventilation in the delivery room
Time frame: Delivery
Number of Infants Experiencing Neonatal Encephalopathy (Primary Outcome Component)
Neonatal encephalopathy experienced between delivery and discharge
Time frame: Delivery through hospital discharge
Number of Participants by Delivery Method
Method of delivery of the baby: spontaneous, vacuum assisted, forceps, cesarean
Time frame: Delivery
Number of Participants by Indication for Cesarean
indication for the cesarean delivery
Time frame: At any time from randomization through delivery
Number of Participants With an Indication for Forceps or Vacuum Delivery
Indication for delivery by forceps or vacuum
Time frame: During labor through delivery
Median Duration of Labor Post-randomization
Duration of labor in hours after randomization through delivery
Time frame: Onset of Labor through delivery
Number of Neonates With Shoulder Dystocia During Delivery
Presence of shoulder dystocia during delivery
Time frame: Delivery
Number of Participants With Chorioamnionitis
Chorioamnionitis
Time frame: Any time from Randomization through Delivery
Number of Participants Who Had a Postpartum Blood Transfusion
Blood transfusion from delivery and through hospital stay until discharge
Time frame: Delivery through hospital discharge
Number of Participants Experiencing Postpartum Endometritis
Postpartum endometritis
Time frame: Delivery through hospital discharge
Median Length of Hospital Stay
Days of stay in the hospital
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Time frame: From admission to labor and delivery through hospital discharge
Number of Infants Admitted to Special Care Nursery
Intermediate care nursery or neonatal intensive care (anything more than well-baby nursery)
Time frame: Delivery and 1 month of age
Median Apgar Score at 5 Minutes
The Apgar score is a simple method of quickly assessing the health and vital signs of a newborn baby created by and named after Dr. Virginia Apgar. Apgar testing assesses Appearance, Pulse, Grimace and Activity in a newborn and is typically done at one and five minutes after a baby is born, and it may be repeated at 10, 15, and 20 minutes if the score is low. The five criteria are each scored as 0, 1, or 2 (two being the best), and the total score is calculated by then adding the five values obtained. Agar scores of 0-3 are critically low, 4-6 are below normal, and indicate that the baby likely requires medical intervention, scores of 7+ are considered normal. The lower the Apgar score, the more alert the medical team should be to the possibility of the baby requiring intervention. Some components of the Apgar score are subjective, and there are cases in which a baby requires urgent medical treatment despite having a high Apgar score.
Time frame: 5 minutes after Delivery
Number of Infants With Meconium Aspiration Syndrome
Meconium aspiration syndrome
Time frame: Delivery through discharge
Number of Infants With a Major Congenital Malformation
Major congenital malformation
Time frame: Delivery