Trial Summary
What is the purpose of this trial?Maternal Fetal Monitoring devices assist the health care professional in acquiring, monitoring, and storing fetal and maternal physiologic data which supports the decision making for pregnant women and the overall fetal health status during pregnancy and delivery. This study aims to support a new maternal fetal monitoring device with clinical data to demonstrate the equivalent performance against the currently marketed Corometrics 259cx. The fetal heart rate and will be collected during antenatal monitoring using standard of care Doppler ultrasound.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications.
What data supports the idea that Fetal Monitoring Device for Pregnancy is an effective treatment?
The available research shows that fetal heart rate monitoring can improve outcomes in high-risk pregnancies. One study found that monitored high-risk deliveries had significantly lower rates of intrapartum and early neonatal mortality compared to unmonitored ones. However, another study found no difference in infant outcomes between monitored and unmonitored groups, but noted a higher rate of cesarean sections in the monitored group. This suggests that while fetal monitoring may help in some cases, it might not always lead to better outcomes and could increase the likelihood of cesarean deliveries.
12345What safety data exists for the fetal monitoring device used in pregnancy?
The safety data for the fetal monitoring device is not explicitly detailed in the provided research. However, the research highlights the importance of developing standard definitions and grading for maternal and fetal adverse events to improve safety monitoring in pregnancy trials. It also discusses the need for better safety evaluation processes for non-active implantable medical devices (NAIMDs), like fetal monitoring devices, compared to medicines. The research suggests that adopting certain drug safety evaluation features could enhance the systematic evaluation of NAIMDs. Additionally, the importance of post-market surveillance and risk management plans for assessing risks associated with new medical products, including fetal monitoring devices, is emphasized.
678910Is the Investigational Fetal Monitoring Device a promising treatment for pregnancy?
Yes, the Investigational Fetal Monitoring Device is promising because it can continuously monitor the baby's heart rate and movements, providing important information about the baby's health. This helps doctors detect any problems early and take action to keep both the mother and baby safe.
1112131415Eligibility Criteria
This clinical trial is for pregnant women who are carrying one baby (singleton pregnancy). It's designed to test a new fetal monitoring device during pregnancy and delivery. Participants should be in good health with no conditions that would interfere with the study.Inclusion Criteria
I am 18 years old or older.
Able and willing to provide written informed consent
Singleton pregnancy
+2 more
Exclusion Criteria
Multiple pregnancy
I have a health condition that may prevent me from participating in the study.
Inability to understand the consent information due to medical illness, diminished intellectual capacity, or insurmountable language barrier
+1 more
Participant Groups
The trial is testing a new fetal monitoring device against an existing one, Corometrics 259cx. The goal is to see if the new device can match or improve on the performance of the current standard by tracking fetal heart rate using Doppler ultrasound.
3Treatment groups
Active Control
Group I: Group 1: 22 0/7 - 24 6/7 WeeksActive Control2 Interventions
All subjects will undergo the same interventions as part of the study procedures but will be divided into groups based on gestational age groups. Each study subject will undergo two 30-minute monitoring sessions (60 minutes total). One with FDA approved device and one with the investigational device. During both monitoring sessions, maternal pulse rate (MPR) will be monitored using SpO2 and the investigator shall be present to adjust the transducer placement as needed
Group II: Group 2: 25 0/7 - 31 6/7 WeeksActive Control2 Interventions
All subjects will undergo the same interventions as part of the study procedures but will be divided into groups based on gestational age groups. Each study subject will undergo two 30-minute monitoring sessions (60 minutes total). One with FDA approved device and one with the investigational device. During both monitoring sessions, maternal pulse rate (MPR) will be monitored using SpO2 and the investigator shall be present to adjust the transducer placement as needed.
Group III: Group 3: Greater than or equal to 32 0/7 WeeksActive Control2 Interventions
All subjects will undergo the same interventions as part of the study procedures but will be divided into groups based on gestational age groups. Each study subject will undergo two 30-minute monitoring sessions (60 minutes total). One with FDA approved device and one with the investigational device. During both monitoring sessions, maternal pulse rate (MPR) will be monitored using SpO2 and the investigator shall be present to adjust the transducer placement as needed.
Investigational Fetal Monitoring Device is already approved in United States for the following indications:
🇺🇸 Approved in United States as Investigational Fetal Monitoring Device for:
- Monitoring fetal and maternal physiologic data during pregnancy and delivery
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Element Materials TechnologyLouisville, CO
Loading ...
Who Is Running the Clinical Trial?
GE HealthcareLead Sponsor
References
Fetal assessment during pregnancy. [2016]Fetal monitoring during pregnancy is used to prevent fetal death. This article addresses the goals of fetal monitoring during pregnancy. Methods of fetal surveillance are reviewed, as well as the meaning of abnormal fetal testing and how these results relate to fetal and neonatal outcome. Overall, pediatricians who understand the goals, methods, and interpretation of fetal testing can communicate more effectively with the delivering obstetric team in anticipation of optimizing obstetric and pediatric outcomes.
[The usefulness of the intrapartum fetal pulse oximetry in anticipating the neonatal outcome]. [2017]The aim of the study was to evaluate the usefulness of the intrapartum fetal pulse oximetry in anticipating the neonatal outcome.
The evaluation of continuous fetal heart rate monitoring in high-risk pregnancy. [2019]Intrapartum electronic fetal heart rate monitoring of the high-risk obstetric patient is thought to improve the perinatal outcome. A prospective randomized study of 483 high-risk obstetric patients in labor was carried out comparing the effectiveness of electronic fetal monitoring with auscultation of fetal heart tones. The infant outcome was measured by neonatal death, Apgar scores, cord blood gases, and neonatal nursery morbidity. There were no differences in the infant outcomes in any measured category between the electronically monitored group and the auscultated group. The cesarean section rate was markedly increased in the monitored group (16.5 vs. 6.8 per cent in the auscultated patients). The presumptive benefits of electronic fetal monitoring for improving fetal outcome were not found in this study.
Women's evaluations of their experience in a multicenter randomized controlled trial of intrapartum fetal pulse oximetry (The FOREMOST Trial). [2007]Fetal pulse oximetry improves the assessment of fetal well-being during labor. The objective of this study was to evaluate women's satisfaction with their experience with this additional technology.
Perinatal outcome in monitored and unmonitored high-risk deliveries. [2006]The benefit of fetal heart rate monitoring was evaluated by comparing the perinatal outcome in 1.246 high-risk pregnancies and deliveries--554 monitored and 692 unmonitored. Intrapartum and early neonatal mortality were significantly lower in the monitored group (P less than 0.05). This study provides evidence that fetal heart rate monitoring improves the fetal outcome of high-risk deliveries.
Development of standard definitions and grading for Maternal and Fetal Adverse Event Terminology. [2022]Adverse event (AE) monitoring is central to assessing therapeutic safety. The lack of a comprehensive framework to define and grade maternal and fetal AEs in pregnancy trials severely limits understanding risks in pregnant women. We created AE terminology to improve safety monitoring for developing pregnancy drugs, devices and interventions.
Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines. [2018]Recent safety issues involving non-active implantable medical devices (NAIMDs) have highlighted the need for better pre-market and post-market evaluation. Some stakeholders have argued that certain features of medicine safety evaluation should also be applied to medical devices. Our objectives were to compare the current processes and methodologies for the assessment of NAIMD safety profiles with those for medicines, identify potential gaps, and make recommendations for the adoption of new methodologies for the ongoing benefit-risk monitoring of these devices throughout their entire life cycle. A literature review served to examine the current tools for the safety evaluation of NAIMDs and those for medicines. We searched MEDLINE using these two categories. We supplemented this search with Google searches using the same key terms used in the MEDLINE search. Using a comparative approach, we summarized the new product design, development cycle (preclinical and clinical phases), and post-market phases for NAIMDs and drugs. We also evaluated and compared the respective processes to integrate and assess safety data during the life cycle of the products, including signal detection, signal management, and subsequent potential regulatory actions. The search identified a gap in NAIMD safety signal generation: no global program exists that collects and analyzes adverse events and product quality issues. Data sources in real-world settings, such as electronic health records, need to be effectively identified and explored as additional sources of safety information, particularly in some areas such as the EU and USA where there are plans to implement the unique device identifier (UDI). The UDI and other initiatives will enable more robust follow-up and assessment of long-term patient outcomes. The safety evaluation system for NAIMDs differs in many ways from those for drugs, but both systems face analogous challenges with respect to monitoring real-world usage. Certain features of the drug safety evaluation process could, if adopted and adapted for NAIMDs, lead to better and more systematic evaluations of the latter.
Sources of Safety Data and Statistical Strategies for Design and Analysis: Postmarket Surveillance. [2020]Safety data are continuously evaluated throughout the life cycle of a medical product to accurately assess and characterize the risks associated with the product. The knowledge about a medical product's safety profile continually evolves as safety data accumulate.
Risk management and monitoring methods for the future mother, embryo, fetus, and post-natal consequences. [2019]Data required to asses the risk of a new drug regarding the normal course of pregnancy as well as embryo, fetal and neonate development, are often missing when a new product is launched. In such a situation, a risk management plan is to be developed by the industrial and validated by regulatory authorities. This risk management plan is to take into account the data benefits on the drug and its potential therapeutic use by women as being of childbearing age. The obtaining of post licence human data is to be built on many players, both private and public, involved in the data collection and evaluation. The setting up of such a network would allow them to join together and optimize their action by standardizing the data collected and their follow up. This should help to generate or rapidly respond to an alert, to conduct collaborative pharmacovigilance pharmacology studies.
Identifying neonatal adverse events in preterm and term infants using a paediatric trigger tool. [2023]To explore the incidence and characteristics of inpatient neonatal adverse events in a Swedish setting.
Measurement of fetal heart rate variability on an electronic monitor using a prototype electronic ruler. [2012]To develop a prototype electronic ruler for assessment of fetal heart rate (FHR) variability on an electronic monitor and test its reliability and accuracy.
Fetal movements recorder, use and indications. [2019]A new device for recording fetal movements is presented. This device is composed of 2 sensors, incorporating a highly sensitive piezoelectric material. It is sensitive to rapid straining forces such as fetal movements and relatively insensitive to steady, slow movements such as uterine contractions and maternal respiratory movements. In this study of 20 women, the sensors were placed on 2 different zones of the abdomen, usually above the umbilicus. There was a good correlation between fetal movements recorded by the device and those felt by the patients. Seventy percent of all observed fetal movements recorded by the device were registered simultaneously by the women. The device recorded 90.4 percent and the women recorded 79.7 percent of all such movements.
A CNN-RNN unified framework for intrapartum cardiotocograph classification. [2023]Prenatal fetal monitoring, which can monitor the growth and health of the fetus, is very vital for pregnant women before delivery. During pregnancy, it is crucial to judge whether the fetus is abnormal, which helps obstetricians carry out early intervention to avoid fetal hypoxia and even death. At present, clinical fetal monitoring widely used fetal heart rate monitoring equipment. Fetal heart rate and uterine contraction signals obtained by fetal heart monitoring equipment are important information to evaluate fetal health status.
A systematic scoping review to identify the design and assess the performance of devices for antenatal continuous fetal monitoring. [2023]Antepartum fetal monitoring aims to assess fetal development and wellbeing throughout pregnancy. Current methods utilised in clinical practice are intermittent and only provide a 'snapshot' of fetal wellbeing, thus key signs of fetal demise could be missed. Continuous fetal monitoring (CFM) offers the potential to alleviate these issues by providing an objective and longitudinal overview of fetal status. Various CFM devices exist within literature; this review planned to provide a systematic overview of these devices, and specifically aimed to map the devices' design, performance and factors which affect this, whilst determining any gaps in development.
Clinical implications from monitoring fetal activity. [2019]The monitoring of fetal motion in high-risk pregnancies has been shown to be worthwhile in predicting fetal distress and impending fetal death. The maternal recording of perceived fetal activity is an inexpensive surveillance technique which is most useful when there is chronic uteroplacental insufficiency or when a stillbirth may be expected. The presence of an active, vigorous fetus is reassuring, but documented fetal inactivity required a reassessment of the underlying antepartum complication and further fetal evaluation with real-time ultrasonography, fetal heart rate testing, and biochemical testing. Fetal distress from such acute changes as abruptio placentae or umbilical cord compression may not be predicted by monitoring fetal motion. Although not used for routine clinical investigation, electromechanical devices such as tocodynamometry have provided much insight into fetal behavioral patterns at many stages of pregnancy and in pregnancies with an antepartum complication.