Fetal Monitoring Device for Pregnancy
Recruiting in Palo Alto (17 mi)
Overseen byMonica Rabanal, NP
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: GE Healthcare
Disqualifiers: Non-twin pregnancy, others
No Placebo Group
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 support clinical decision making for pregnant women and assesses the overall fetal health status during pregnancy and delivery. This study aims to support a new maternal fetal monitoring device with clinical data by collecting simultaneous, continuous, external, distinguishable FHRs from twin pregnancies using ultrasound Doppler transducers from the new maternal fetal monitoring investigational device and a marketed ultrasound imaging device.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What data supports the effectiveness of the treatment Investigational Fetal Monitor?
Research on fetal pulse oximetry, a similar technology, shows it can improve the assessment of fetal well-being during labor. Additionally, a new wireless fetal monitoring system has been developed to improve comfort and mobility while accurately capturing fetal heart rate and uterine activity.
12345Is the fetal monitoring device generally safe for use in humans?
The FDA requires premarket approval for obstetric devices like fetal monitors to ensure they meet safety standards, which helps reduce the risk of illness or injury during use.
678910How is the Investigational Fetal Monitor different from other fetal monitoring treatments?
The Investigational Fetal Monitor is unique because it allows for fetal monitoring from home, transmitting data quickly and accurately over standard telephone lines, which is not a feature of traditional hospital-based monitors. This enables immediate interpretation by experts without the need for hospital visits, making it more convenient for pregnant women.
1112131415Eligibility Criteria
This trial is for pregnant women carrying twins. It's designed to test a new fetal monitoring device that tracks the health of both babies and the mother during pregnancy and delivery.Inclusion Criteria
Greater than or equal to 30 0/7 weeks gestation
Twin pregnancy
I am 18 years old or older.
+2 more
Exclusion Criteria
Involvement in another clinical trial currently or previously in this pregnancy that, in the investigator's opinion, would affect the conduct of this study
Non-twin pregnancy
Inability to understand the consent information due to medical illness, diminished intellectual capacity, or insurmountable language barrier
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Monitoring Session
Pregnant women of ≥30 0/7 weeks gestation undergo a 40-minute monitoring session using the investigational device with Doppler transducers
40 minutes
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after the monitoring session
4 months
Participant Groups
The study compares a new investigational fetal monitor with an existing ultrasound imaging device, focusing on their ability to continuously track heart rates in twin pregnancies using ultrasound Doppler transducers.
1Treatment groups
Experimental Treatment
Group I: Twin Monitoring - All SubjectsExperimental Treatment2 Interventions
Pregnant women of ≥30 0/7 weeks gestation will undergo one 40-minute monitoring session utilizing the investigational device with two Doppler transducers (FHR 1 and FHR 2) following M- mode fetal ultrasound imaging confirming fetal presentation, fetal lie, visualization of fetal heart rates of each fetus and documentation. During the monitoring sessions, maternal pulse rate (MPR) will be monitored using a SpO2 sensor and the investigator shall be present to adjust the transducers as needed to maintain a continuous FHR tracing.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Element Materials TechnologyLouisville, CO
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Who Is Running the Clinical Trial?
GE HealthcareLead Sponsor
References
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.
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.
Current status of the multicenter randomized clinical trial on fetal oxygen saturation monitoring in the United States. [2019]Current clinical methods of intrapartum fetal assessment are sensitive but poorly specific in detecting fetal compromise during labor. These limitations have substantially contributed to the escalating cesarean section rate which occurred in the US during the last several decades. Experimental and clinical research efforts directed towards application of the oxygen saturation monitor (pulse oximeter) to intrapartum fetal assessment have produced encouraging results. If this new method of fetal assessment is to enter the clinical arena, safety and efficacy issues must first be properly evaluated via randomized clinical trials. The purpose of this report is to describe the design of a multicenter randomized clinical trial of intrapartum fetal oxygen saturation monitoring recently begun in the US. Specific aspects of the trial, including purpose, study design, sample size estimates, control and test groups, inclusion and exclusion criteria, fetal heart rate classification, definition of normal fetal arterial oxygen saturation (SpO2), clinical management protocol, and assessment of maternal-fetal outcomes will be addressed.
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.
Wearable Fetal Monitoring Solution for Improved Mobility During Labor & Delivery. [2020]Electronic fetal monitoring (EFM) is used widely during labor & delivery, but existing solutions limit patient mobility, are uncomfortable, and do not consistently capture fetal heart rate (FHR) and uterine activity (UA) signals. A wireless EFM system was developed that features wearable US and tocodynamometer devices that conform to the body and do not require cables or belts. Benchtop testing demonstrated that the devices can accurately and consistently measure simulated FHRs and UAs over clinically meaningful ranges and body curvatures. The wearable EFM devices are expected to provide more reliable signal capture independent of maternal movement and repositioning, while also significantly improving patient comfort and mobility.
A primer of drug safety surveillance: an industry perspective. Part I: Information flow, new drug development, and federal regulations. [2019]To place the fundamentals of clinical drug safety surveillance in a conceptual framework that will facilitate understanding and application of adverse drug event data to protect the health of the public and support a market for pharmaceutical manufacturers' products. Part I of this series provides a background for the discussion of drug safety by defining the basic terms and showing the flow of safety information through a pharmaceutical company. The customers for adverse drug event data are identified to provide a basis for providing quality service. The development of a drug product is briefly reviewed to show the evolution of safety data. Drug development and safety are defined by federal regulations. These regulations are developed by the FDA with information from pharmaceutical manufacturers. The intent of the regulations and the accompanying guidelines is described. An illustration from the news media is cited to show an alternative, positive approach to handling an adverse event report.
Medical devices; effective date of requirement for premarket approval for a class III preamendments obstetrical and gynecological device. Food and Drug Administration, HHS. Final rule. [2004]The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of product development protocol (PDP) for a Group 1 preamendments class III device, the obstetric data analyzer intended to analyze data from fetal and maternal monitors during labor and to warn of possible fetal distress. The agency has summarized its findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the device to meet the statute's approval requirements and the benefits to the public from the use of the devices.
[Drug safety in pregnancy-a particular challenge]. [2019]Drug safety in pregnancy is of utmost importance because prenatal exposure to the unborn child may result in side effects with life-long consequences. Data on their risks in pregnancy are scarce for many drugs. Furthermore, there is often uncertainty how to translate risk data into practice.This article aims to identify tools to improve data ascertainment on exposed pregnancies and their outcome. Using the example of the German Embryotox institute, it is demonstrated how to disseminate drug safety knowledge to healthcare professionals and patients for clinical decision-making.Observational data are the most important basis for drug risk assessment in pregnancy. Such data are collected by Embryotox through the risk consultation process. Prospective cohort studies with comparison cohorts allow to estimate relative risks for birth defects, pregnancy loss, and other developmental anomalies. Retrospectively ascertained adverse drug reactions contribute to identification of distinct pattern of congenital anomalies.Drugs in pregnancy counselling require risk characterization dependent on the individual clinical setting: recommendation of treatment of choice (comparative risk assessment between effective drugs), individual risk estimation after (inadvertent) exposure, and assessment of causal relationship in cases of congenital anomalies. Combining counselling and protocols of pregnancy outcome after drug exposure is optimal to cost-efficiently ascertain data of high quality.Using acetaminophen, valproic acid, AT1-receptor blockers and retinoids as examples, recent discussions on drug risks in pregnancy and their clinical implications are presented.
An alternative to product-specific pregnancy registries? PRIM; PRegnancy outcomes Intensive Monitoring. [2021]Patient safety during pregnancy is an important concern. This article presents a method of using an industry safety database to access prospective pregnancy cases. This method, termed here 'PRegnancy outcomes Intensive Monitoring' (PRIM) was developed for fingolimod (Gilenya ™), a treatment option for multiple sclerosis (MS), due to slow enrollment in the company pregnancy registry. The aim of PRIM was to enhance the process of pregnancy data collection and improve data quality, and in particular to enable estimation of the proportion of major congenital malformation and other pregnancy outcomes. To do this, the spontaneous reports of maternal exposure to fingolimod in pregnancy or in the eight weeks immediately before the last menstrual period of patients not enrolled in the pregnancy registry were identified. Follow up checklists were sent at four time points: initial pregnancy report, end of pregnancy, infant attained 3 and 12 months of age. These focused on core data required for derivation of programmed analyses. From 01 Mar 2014 to 28 Feb 2018, a total of 831 prospective maternal exposures with 843 infants were reported, with fetal outcomes reported in 459/843 (54.4 %) of those infants. This enabled the calculation of proportions of pregnancy cases with the main pregnancy outcomes and of fetal cases with malformation. The number of reported pregnancies was significantly higher in PRIM than in the registry, showing that structured use of pharmacovigilance data enables speedier assessment of risks of maternal drug exposure.
Learning the effects of psychotropic drugs during pregnancy using real-world safety data: a paradigm shift toward modern pharmacovigilance. [2021]The growing evidence on psychotropic drug safety in pregnancy has been possible thanks to the increasing availability of real-world data, i.e. data not collected in conventional randomised controlled trials. Use of these data is a key to establish psychotropic drug effects on foetal, child, and maternal health. Despite the inherent limitations and pitfalls of observational data, these can still be informative after a critical appraisal of the collective body of evidence has been done. By valuing real-world safety data, and making these a larger part of the regulatory decision-making process, we move toward a modern pregnancy pharmacovigilance. The recent uptake of real-world safety data by health authorities has set the basis for an important paradigm shift, which is integrating such data into drug labelling. The recent safety assessment of sodium valproate in pregnant and childbearing women is probably one of the first examples of modern pregnancy pharmacovigilance.
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.
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.
The nonstress test. Transmission from the home. [2004]The Genesis Fetal Monitor System, which includes a recorder, a communication module and a receiver system, accurately and rapidly transmits a complete antenatal fetal monitor tracing over standard telephone lines and duplicates the original tracing at the receiver center. Transmission time for a 20-minute nonstress test is less than 2 minutes. The time required to generate a duplicate strip is less than 30 seconds. In all cases in this study the original and generated tracings were superimposable. No significant technical problems were encountered. Bioelectronic fetal assessment can be performed from a nonhospital setting, including the patient's home, with immediate interpretation of the tracing by skilled consultants.
[Clinical experience of long-distance electronic fetal heart rate monitoring system by telephone]. [2006]To explore the value of the long-distance electronic fetal heart rate monitoring system by telephone and explore a new way of self-monitoring at home for pregnant woman.
New instrument developments for fetal pH monitoring. [2019]Recent technical improvements in the ROCHE fetal pH monitor have simplified its use and increased the proportion of useful and accurate recordings. These improvements include electronic changes to reduce static electricity, a new spiral electrode which stabilizes the pH electrode in the fetal scalp, improved incision tools, simplified applicator tools, and a total system for reducing pH electrode handling during calibration.