Evaluation of the Novii External Fetal Monitoring Device: A Prospective, Randomized Comparison
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 218
- 试验地点
- 8
- 主要终点
- Amount of time in minutes with the interpretable fetal heart rate tracing during the course of labor.
研究概览
简要总结
This study will be conducted on women in labor. Fetal heart rate monitoring will be conducting using the Novii Fetal ECG/EMG system and comparing it to current standard of care external fetal heart rate and tocometry. These approaches will be compared with the respect to need for additional monitoring, amount of nursing intervention, cost and satisfaction of patients and healthcare providers.
详细描述
Interpretation of fetal heart rate monitoring during labor is one of the most common procedures performed in the practice of obstetrics. Continuous monitoring of the fetal heart rate is used to identify infants at risk for hypoxic ischemic encephalopathy and allow for intervention to prevent this terrible complication. The quality of the fetal heart rate signal is critical for appropriate interpretation of the characteristics that identify risk.
This is a prospective, randomized pragmatic trial comparing the Novii Fetal ECG/EMG system to external fetal heart rate and tocometry (standard of care) for the amount of time of interpretable fetal heart rate during labor. Randomization will occur in blocks based on BMI to control for the potential effect of BMI.
Fetal heart rate tracings from both groups of women will be reviewed in a blinded fashion by experienced Maternal Fetal Medicine (MFM) physicians who will assess the tracing for quality and interpretability. In addition, both approaches will be compared with respect to the need for additional monitoring modalities, amount of nursing intervention, cost and satisfaction of the patients and healthcare providers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women ≥ 18 years of age; gestational age ≥ 37 weeks
- •Singleton pregnancy.
- •These women will be those presenting to Labor and Delivery for one of the following:
- •Rule out labor
- •Spontaneous labor
- •Induction of labor
排除标准
- •Age < 18 years old; multiple gestation pregnancy; gestational age < 37 weeks
- •Fetal distress or vaginal bleeding prior to monitor placement
- •Previous cesarean section
- •Planned cesarean delivery.
- •Women who are enrolled in the study but have less than 1 hour of fetal heart rate monitoring after randomization will be excluded from analysis.
研究组 & 干预措施
Novii Device ECG/EMG System
These patients will have the Novii ECG/EMG system placed throughout labor and delivery, unless a provider or investigator determines that a different device (internal or external) is necessary for a better signal.
干预措施: Novii ECG/EKG System (Device)
Standard of Care External Monitor
A standard external monitor will be placed throughout labor and delivery, unless a provider or investigator determines that an internal device is necessary for a better signal.
干预措施: External fetal heart rate monitoring (Device)
结局指标
主要结局
Amount of time in minutes with the interpretable fetal heart rate tracing during the course of labor.
时间窗: Time of randomization until time of delivery (up to 48 hours)
Quality of the fetal heart rate for each minute of tracing will be assessed visually by 2 or more blinded reviewers. For the purpose of this study, uninterpretable fetal heart rate will be defined as continuous fetal heart rate data with one or more of the following: 1. Data is missing for more than 75% of the minute of tracing 2. Artifact is present for more than 25% of the minute of tracing 3. Missing data or artifact prevents determination of baseline rate 1. \> 15 seconds of continuous missing tracing 2. Missing data is not continuous but is sufficiently frequent that the one minute segment of tracing could not be used to determine baseline rate The total number of interpretable minutes of fetal heart tracing and the percentage of time with interpretable fetal heart tracing over the course of labor (Number of minutes with interpretable FHR/Total number of minutes in labor) will be calculated for each patient.
次要结局
- Maternal outcomes - Length of labor(Hospitalization for labor, delivery, and recovery - 2-4 days)
- Need for additional monitoring devices such as change from Novii to standard monitoring devices or the use of intrauterine pressure catheter or fetal scalp electrode:(Time of randomization until time of delivery (up to 48 hours))
- Neonatal outcomes - Neonatal Sex(Hospitalization after delivery - 2-4 days)
- Patient and provider satisfaction - Nurse Survey(Up to 7 days after delivery)
- Maternal outcomes - Estimated blood loss(Hospitalization for labor, delivery, and recovery - 2-4 days)
- Quality and interpretability of the FHT in ten minute segments(Time of randomization until time of delivery (up to 48 hours))
- Maternal outcomes - Delivery type(Hospitalization for labor, delivery, and recovery - 2-4 days)
- Maternal outcomes - Intra-amniotic infection (clinical chorioamnionitis or triple I)(Hospitalization for labor, delivery, and recovery - 2-4 days)
- Neonatal outcomes - APGAR Scores(Hospitalization after delivery - 2-4 days)
- Neonatal outcomes - Birthweight(Hospitalization after delivery - 2-4 days)
- Patient and provider satisfaction - Patient Survey(Up to 7 days after delivery)
- Maternal outcomes - Indication for forceps/vacuum extraction or cesarean section, if performed(Hospitalization for labor, delivery, and recovery - 2-4 days)
- Maternal outcomes - Presence and severity of perineal lacerations(Hospitalization for labor, delivery, and recovery - 2-4 days)
- Maternal outcomes - Presence of clinical endometritis(Hospitalization for labor, delivery, and recovery - 2-4 days)
- Neonatal outcomes - Need for ICU Admission(Hospitalization after delivery - 2-4 days)
- Patient and provider satisfaction - Attending Physician/Midwife Survey(Up to 7 days after delivery)
- Number and quality of uterine contractions in each 10 minute segment:(Time of randomization until time of delivery (up to 48 hours))
- Number of times fetal heart rate monitor requires adjusting:(Time of randomization until time of delivery (up to 48 hours))
- Need for additional monitoring devices such as change from Novii to standard monitoring devices or the use of intrauterine pressure catheter or fetal scalp electrode will be recorded by clinical care team:(Time of randomization until time of delivery (up to 48 hours))
- Nursing time required for care:(Time of randomization until time of delivery (up to 48 hours))
- Overall cost of care:(Hospitalization for labor, delivery, and recovery - 2-4 days)
研究者
Michael Sean Esplin
Professor, Division of Maternal Fetal Medicine
Intermountain Health Care, Inc.