Fetal ST Segment and T Wave Analysis in Labor

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Trial of Fetal ECG ST Segment and T Wave Analysis as an Adjunct to Electronic Fetal Heart Rate Monitoring (STAN)

Conditions
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Pregnancy, Obstetric Labor, Parturition

Intervention / Treatment
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* Device: fetal STAN monitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Singleton, cephalic pregnancy Gestational age at least 36 weeks, 1 day Cervical dilation of at least 2 cm and no more than 7 cm Ruptured membranes Exclusion Criteria: Multifetal gestation Planned cesarean delivery Need for immediate delivery Absent variability or sinusoidal pattern at any time, or a Category II fetal heart rate pattern with absent variability in the last 20 minutes before randomization Inability to obtain or maintain an adequate signal within 3 trials of electrode placements Occurrence of any ST event during attempt to obtain adequate signal Patient pushing in the first stage of labor Known major fetal anomaly or fetal demise Previous uterine surgery Placenta previa on admission Maternal fever greater than or equal to 38 C or 100.4 F Active HSV infection Known HIV or hepatitis infection Other maternal and fetal contraindications for using the STAN monitor Enrollment in another labor study Participation in this trial in a previous pregnancy No certified or authorized provider available
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study is a randomized, controlled clinical trial of 11,000 women in labor at > 36.0 weeks gestation randomized to one of two groups using the STAN S31 system: Fetal STAN electrode inserted and data available to caregivers (open device group) Fetal STAN electrode inserted, but data masked to the caregivers (masked device group)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Group<br>• Fetal STAN monitor electrode inserted and data available to caregivers | Device: fetal STAN monitor<br>* 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.<br>* Other names: STAN S31;|
| Other: Masked Group<br>•Fetal STAN monitor electrode inserted, but data masked to the caregivers | Device: fetal STAN monitor<br>* 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.<br>* Other names: STAN S31;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | From Delivery through 1 month of age | 
| Number of Intrapartum Fetal Deaths (Primary Outcome Component) | Death of the fetus during the intrapartum period. | 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 | 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. | 5 minutes after delivery | 
| Number of Infants Who Experienced Neonatal Seizure (Primary Outcome Component) | Number of infants who experienced Neonatal Seizure | 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 | Delivery | 
| Number of Neonates Intubated for Ventilation at Delivery (Primary Outcome Component) | Neonatal intubation for ventilation in the delivery room | Delivery | 
| Number of Infants Experiencing Neonatal Encephalopathy (Primary Outcome Component) | Neonatal encephalopathy experienced between delivery and discharge | Delivery through hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants by Delivery Method | Method of delivery of the baby: spontaneous, vacuum assisted, forceps, cesarean | Delivery | 
| Number of Participants by Indication for Cesarean | indication for the cesarean delivery | 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 | During labor through delivery | 
| Median Duration of Labor Post-randomization | Duration of labor in hours after randomization through delivery | Onset of Labor through delivery | 
| Number of Neonates With Shoulder Dystocia During Delivery | Presence of shoulder dystocia during delivery | Delivery | 
| Number of Participants With Chorioamnionitis | Chorioamnionitis | 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 | Delivery through hospital discharge | 
| Number of Participants Experiencing Postpartum Endometritis | Postpartum endometritis | Delivery through hospital discharge | 
| Median Length of Hospital Stay | Days of stay in the hospital | 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) | 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. | 5 minutes after Delivery | 
| Number of Infants With Meconium Aspiration Syndrome | Meconium aspiration syndrome | Delivery through discharge | 
| Number of Infants With a Major Congenital Malformation | Major congenital malformation | Delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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STAN, Fetal monitoring, Fetal acidosis, Fetal heart rate monitoring, Perinatology