Clinical trials: Fetal Monitoring
Fetal Heart Rate or Rhythm Abnormality Affecting Newborn During Labor, Uterine Contractions
Noninvasive Monitoring of Uterine Activity and Fetal Heart Rate
A clinical study designed to validate the safety and performance of the TrueLabor™ device in monitoring labor vs. current standard of care.
- Conditions
- Fetal Heart Rate or Rhythm Abnormality Affecting Newborn During Labor, Uterine Contractions, Obstetric Complication
- Trial name
- NCT05782296
- Testing
- TrueLabor
- Where
- 3 sites in United States, Israel
- Volunteers
- 80 people
- Sponsor
- OB-Tools Ltd.
Pregnancy
Evaluating the Safety of PregSense™ and Compare Its Performance to CTG in Prenatal Monitoring of Pregnant Subjects
This clinical study will evaluate the safety of PregSense™ and Comparative Performance of PregSense™ versus CTG in Prenatal Monitoring of Pregnant subjects.
- Trial name
- NCT03504189
- Testing
- PregSense™, Cardiotocopraphy (CTG)
- Where
- 4 sites in United States, Germany and 1 more
- Volunteers
- 151 people
- Sponsor
- Nuvo-Group, Ltd.
Pregnancy; Habitual Aborter, Weeks of Gestation 37 or More
Accuracy and Reliability of Fetal Heart Rate and Uterine Contraction Monitoring Method
Clinical Investigation Protocol for a study designed to determine the equivalence of the Monica AN24 monitor to Philips 50XM for fetal heart rate (FHR) and uterine contraction (UC) monitoring during labor.
- Trial name
- NCT01280357
- Testing
- Monica AN24 (K101081), Philips 50XM
- Where
- 2 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Monica Healthcare Ltd
Fetus Pulse Monitoring
Fetal Heart Rate Characterization Using Innovative Advanced Non-invasive Technology
The purpose of the study is to examine the effectiveness and reliability of fetal heart rate monitoring by the Oxitone device. Today, fetal monitoring is carried out with an external approach using a Doppler transducer placed on…
- Trial name
- NCT05853146
- Testing
- Oxitone 1000M
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Oxitone Medical Ltd.
Labor Pain, Contraction
Fetal Life: Smart-Device Based Uterine Activity Monitoring
This study will compare the performance of a contraction monitor (tocometer) device developed by Fetal Life with standard tocometer devices.
- Trial name
- NCT03940365
- Testing
- Fetal Life tocometer device
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Fetal Life LLC
Fetal Monitoring
A Clinical Study for the Development of a Device (Lovelace) for Antepartum Fetal Monitoring
Bloomlife Lovelace FT is a non-invasive, wireless, external measurement system used to measure accelerometer and electrophysiological signals on pregnant women with a singleton pregnancy, by acquiring biopotential signals from…
- Trial name
- NCT05665400
- Testing
- Bloomlife Lovelace FT
- Where
- Belgium
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Bloom Technologies
Fetal Monitoring
A Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Antepartum Fetal Monitoring
Bloomlife has developed a wearable system (Bloomlife MFM-Pro) that can allow fetal monitoring to be conveniently performed in healthcare settings under supervision of a healthcare professional.
- Trial name
- NST (NCT05060172)
- Testing
- Bloomlife MFM-Pro
- Where
- Belgium
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Bloom Technologies
Pregnancy, Fetal Monitoring
Use of In-Home Non-Stress Monitoring Device for Fetal Monitoring: A Nonsignificant Risk (NSR) Device Study
This study evaluates the safety and performance of the PregnaOne System, a non-significant risk (NSR) investigational medical device for in-home fetal monitoring in pregnant women during the third trimester.
- Trial name
- NCT07223996
- Testing
- PregnaOne System
- Where
- 3 sites in United States
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Nestmedic Spolka Akcyjna
Fetal Monitoring
A Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Performing Antepartum Fetal Monitoring
Bloomlife MFM-Pro is a non-invasive, wireless, external monitoring system used to measure fetal heart rate and maternal heart rate on pregnant women with a singleton pregnancy, starting from 32 weeks of gestation.
- Trial name
- NST (NCT04915131)
- Testing
- Bloomlife MFM-Pro
- Where
- 2 sites in United States
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- Bloom Technologies
Pregnancy
Safety and Performance of a Fetal Monitoring System
The objective of this study is to demonstrate the safety and performance of the M•care™ System for use in antenatal monitoring of pregnant women ≥ 32 weeks' gestation.
- Trial name
- M•CARE SE (NCT05294211)
- Testing
- M•care™ System, Cardiotocography (CTG)
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Marani Health
Pregnancy
Maternal Fetal Device Performance Twins
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…
- Trial name
- NCT06835647
- Testing
- Investigational Fetal Monitor, Ultrasound Imaging Device
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- GE Healthcare
Pregnancy
This Clinical Study Evaluates the Performance and Safety of Biorithm Research Kit Versus CTG in Prenatal Monitoring of Pregnant Participants.
This clinical study will evaluate the safety and comparative performance of Biorithm Research Kit vs CTG (gold standard) in prenatal monitoring of pregnant participants.
- Trial name
- NCT04941534
- Where
- United Kingdom
- Volunteers
- 100 people
- Sponsor
- Biorithm Pte Ltd
Term Labour
Accuracy and Reliability of Novii: Fetal Heart Rate (FHR), Maternal Heart Rate (MHR) and Uterine Contraction (UA) Compared With Doppler, Scalp Fetal Scalp Electrode (FSE), Tocodynamometer (TOCO) and Intra Uterine Pressure Catheter (IUPC)
Accuracy and Reliability of the Novii device (fetal heart rate, maternal heart rate and uterine activity) compared with Food and Drug Administration (FDA) approved techniques
- Trial name
- NCT03409146
- Testing
- Monica Novii Wireless Patch System
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- GE Healthcare
Pregnancy
Maternal Fetal Device Performance Singleton
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…
- Trial name
- NCT06726343
- Testing
- Fetal Monitoring Device, Investigational Fetal Monitoring Device
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- GE Healthcare
Healthy, Pregnant Women
Comparative Performance of INVU™ Versus Intrauterine Pressure Catheter (IUPC) in Uterine Contractions Monitoring of Pregnant Women.
The primary objective of this research is to assess the agreement between INVU™ and IUPC (the gold standard) during prenatal monitoring of uterine contractions and to assess the safety of INVU™.
- Trial name
- NCT03889405
- Testing
- INVU™, IUPC, TOCO
- Where
- 2 sites in United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Nuvo-Group, Ltd.
Pregnancy Related
Human Factoring Validation of Pulsenmore ES Device
The goal of this study is to conduct human factors validation testing with the Pulsenmore ES home Ultrasound device in the video-guided mode of operation (participants) and the clinician-guided mode of operation (participants and…
- Trial name
- NCT06567067
- Testing
- Pulsenmore ES home ultrasound
- Where
- 2 sites in United States
- Volunteers
- 57 people
- Sponsor
- PulseNmore
Fetal Monitoring
Evaluation of the Goldcrest Patch Performance
The Novii Patch is an accessory to the Novii+ Pod that connects directly to the Novii+ Pod and contains the surface electrodes that attach to the abdomen.
- Trial name
- NCT06355453
- Testing
- Goldcrest Patch and Three Patch Coupons, Goldcrest Patch and Novii Patch
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- GE Healthcare
Pregnancy
Electrode-based Sensor for Non-invasive Fetal Heart Rate and EMG Monitoring With Improved Reliability
The specific goal of the proposed research is to develop a reliable, non-invasive fetal and maternal heart rate and contraction monitor that is unaffected by obesity and requires less nursing intervention than the tocodynamometer…
- Trial name
- NCT01400880
- Testing
- Electrode-based Sensor
- Where
- United States
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- Convergent Engineering, Inc.
Pregnancy Related
Femom System Compared to the Standard of Care CTG
The goal of this observational study is to evaluate the safety and performance of the femom system compared to the standard of care CTG for antepartum fetal monitoring in pregnant women with singleton gestation > 32+0 weeks of…
- Trial name
- NCT06490471
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Biorithm Pte Ltd
Pregnancy Related
AMBulatory Fetal ECG Monitoring in Low and High-Risk Pregnancies
This study is a planned research project to test and demonstrate the feasibility of using the Femom device for monitoring fetal heart rate remotely.
- Trial name
- NCT06497205
- Where
- United Kingdom
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Biorithm Pte Ltd