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临床试验/NCT06822439
NCT06822439招募中不适用

Investigating the Acceptability and Feasibility of Remote Fetal Monitoring in a High Risk Obstetric Population

Beth Israel Deaconess Medical Center1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Percent of sessions completed

研究概览

简要总结

Antenatal nonstress tests (NSTs) are performed to assess fetal health and are used as a cost-effective test that can be widely administered. However, an NST is operator-dependent due to the nature of Doppler ultrasound and is primarily performed in a clinic and hospital setting.

The ability to conduct a clinically valuable test at home would address access to care issues faced by numerous women in the United States and reduce the workload on healthcare clinicians facing a shortage of human resources.

This pilot study aims to assess the feasibility and acceptability of home NST monitoring in order to determine whether femomTM could be utilized as an adjunct to routine prenatal care.

Patients with high risk pregnancies who are recommended to undergo at least once weekly at 32 weeks testing by the obstetrician will be recruited for participation in this study. Participants will be asked to perform three 30 minute monitoring sessions weekly starting at 32 weeks for 6 weeks.

详细描述

Measuring fetal heart rate (FHR) through various methods is essential for assessing fetal wellbeing antenatally. This enables clinicians to identify patterns that could indicate fetal hypoxia.

Cardiotocography (CTG), which uses Doppler ultrasound, is the gold standard for non-invasive FHR monitoring. This technology detects movement in the cardiac structures and approximates the FHR from this and requires signal modulation and auto-correlation to provide accurate quality readings of FHR. This method of external FHR monitoring is prone to signal loss, maternal fetal ambiguity where the maternal heart rate is confused for FHR, and signal artefacts (e.g., double-counting, and half-counting), during both antenatal and intrapartum monitoring, and must be performed by an obstetric provider.

Non-invasive fetal electrocardiography (NIFECG) is a form of electrocardiography (ECG), which captures simultaneous maternal and fetal PQRST waves. NIFECG has the theoretical benefits of minimizing maternal-fetal heart activity confusion, is not affected by maternal adiposity, and delivers no energy to the patient, which permits prolonged periods of fetal monitoring with safety. To date, NIFECG has mostly been limited to research use due to low fetal signal-to-noise ratios. Despite technical challenges, NIFECG may be the most promising method of ambulatory self-applied FHR monitoring.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Intrauterine pregnancy greater than 32 weeks gestation
  • •Recommended for at least once weekly antenatal fetal testing by their obstetrician
  • •English-speaking

排除标准

  • •Under age 18 years of old
  • •Non-english speaking

研究组 & 干预措施

Remote Monitoring

A cohort of patients with high risk pregnancies who will wear a remote monitoring device

干预措施: Fetal ECG monitoring (Device)

结局指标

主要结局

Percent of sessions completed

时间窗: 6 weeks

Percentage of completed remote monitoring sessions

Percentage of interpretable sessions

时间窗: 6 weeks

Percentage of interpretable monitoring sesions

次要结局

  • Patient satisfaction(6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ethan Litman

Clinical Fellow, Division of Maternal Fetal Medicine

Beth Israel Deaconess Medical Center

研究点 (1)

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