A Randomized Trial of Fetal ECG ST Segment and T Wave Analysis as an Adjunct to Electronic Fetal Heart Rate Monitoring (STAN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11,108
- 试验地点
- 25
- 主要终点
- Number of Participants With Primary Composite Outcome
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Care Provider)
盲法说明
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)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Open Group
• Fetal STAN monitor electrode inserted and data available to caregivers
干预措施: fetal STAN monitor (Device)
Masked Group
•Fetal STAN monitor electrode inserted, but data masked to the caregivers
干预措施: fetal STAN monitor (Device)
结局指标
主要结局
Number of Participants With Primary Composite Outcome
时间窗: From Delivery through 1 month of age
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
Number of Intrapartum Fetal Deaths (Primary Outcome Component)
时间窗: During labor and through delivery of the baby
Death of the fetus during the intrapartum period.
Number of Infants With Apgar Score < = 3 at 5 Minutes (Primary Outcome Component)
时间窗: 5 minutes after delivery
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.
Number of Infants Who Experienced Neonatal Seizure (Primary Outcome Component)
时间窗: Birth through hospital discharge
Number of infants who experienced Neonatal Seizure
Number of Neonatal Deaths (Primary Outcome Component)
时间窗: Delivery through1 month of age
Death of the newborn between delivery and1 month of age
Number of Infants Experiencing Neonatal Encephalopathy (Primary Outcome Component)
时间窗: Delivery through hospital discharge
Neonatal encephalopathy experienced between delivery and discharge
Number of Infants With Umbilical-artery Blood pH < = 7.05 and Base Deficit in Extracellular Fluid > = 12 mmol/Liter (Primary Outcome Component)
时间窗: Delivery
Umbilical-artery blood pH \< = 7.05 and base deficit in extracellular fluid \> = 12 mmol/liter
Number of Neonates Intubated for Ventilation at Delivery (Primary Outcome Component)
时间窗: Delivery
Neonatal intubation for ventilation in the delivery room
次要结局
- Median Duration of Labor Post-randomization(Onset of Labor through delivery)
- Number of Participants by Indication for Cesarean(At any time from randomization through delivery)
- Number of Infants Admitted to Special Care Nursery(Delivery and 1 month of age)
- Number of Infants With Meconium Aspiration Syndrome(Delivery through discharge)
- Number of Infants With a Major Congenital Malformation(Delivery)
- Number of Neonates With Shoulder Dystocia During Delivery(Delivery)
- Number of Participants Experiencing Postpartum Endometritis(Delivery through hospital discharge)
- Number of Participants With an Indication for Forceps or Vacuum Delivery(During labor through delivery)
- Number of Participants Who Had a Postpartum Blood Transfusion(Delivery through hospital discharge)
- Median Length of Hospital Stay(From admission to labor and delivery through hospital discharge)
- Number of Participants by Delivery Method(Delivery)
- Median Apgar Score at 5 Minutes(5 minutes after Delivery)
- Number of Participants With Chorioamnionitis(Any time from Randomization through Delivery)