A Pilot Clinical Study to Evaluate the Technical and Operational Performance of Lovelace in Comparison with the Clinical Standard-of-Care CardioTocoGraph (CTG) for Antepartum Fetal Monitoring.
Investigating the Performance of an Investigational Device for Fetal Monitoring
David Haas, MD
Primary Investigator
Brief description of study
The purpose of this study is to evaluate the technical and operational performance of Lovelace in comparison with the clinical standard-of-care CTG for antepartum fetal monitoring (i.e. NST), and to collect evidence of its safety. The main objective is to evaluate the safety and performance of Lovelace for antepartum monitoring in pregnant women at gestational ages of 32 weeks or greater, in comparison with the standard- of-care CardioTocoGraph (CTG).
Detailed description of study
National, multi-center, interventional, single-arm, prospective paired comparison pilot study to evaluate the technical and operational performance of Lovelace in comparison with the standard-of-care CTG device for antepartum fetal monitoring (i.e. Non-Stress-Test).
Participants will be included in one of two groups depending on their pregnancy phase (antepartum or early labor), as established by the clinical team at the time of enrollment:
● Group 1—antepartum: non-laboring participants
evaluated per obstetric standard-of-care in the clinic
environment, and participants completing antenatal
visits or research-only visits with oversight by a
healthcare professional.
● Group 2—contraction enriched: participants in early
(latent) phase of labor with suspected or confirmed
uterine contractions, and participants who are being
induced for labor.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Pregnant, Pregnancy
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Age: 18 years - 100 years
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Gender: Female
Inclusion criteria
Pregnant woman ≥ 18 years old
● Gestational age ≥ 32 weeks and 0 days
● Singleton pregnancy
● Documented fetal heart tones
● Willingness to participate in the study
● Ability to read and understand English or Spanish
Exclusion criteria
● Implanted pacemaker or any other implanted
electrical device
● Plurality higher than 1
● History of allergies to skin adhesives
● Irritated or lesioned skin at the patch location
● Known fetal anomaly (i.e. major structural)
● No fetal heart tones at the time of consent
The purpose of this study is to investigate how well a new device works compared to the usual method for checking on babies before they are born. This study focuses on women who are 32 weeks or more into their pregnancy. It aims to see if the new device is safe and works well when compared to the standard method called CardioTocoGraph (CTG), which is used to monitor the baby's heart rate and the mother's contractions before birth.
In this study, pregnant women will be monitored using both the new device and the standard CTG method. Participants will be divided into two study arms based on their stage of pregnancy. One group will include women who are not yet in labor, and the other group will include women who are in early labor or having contractions. The study will take place in a clinic where healthcare professionals will oversee the monitoring.
- Who can participate: Pregnant women aged 18 years or older, with a singleton pregnancy of at least 32 weeks, can participate. Participants must have documented fetal heart tones and be able to read and understand English or Spanish.
- Study details: Participants will be monitored using the investigational device and the standard CTG method. They will be part of one of two study arms based on their pregnancy phase. The study will take place in a clinic setting with healthcare oversight.
Interested in the study?
This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.
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