Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase
0During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
About this study
The objective of this study is to demonstrate the safety and performance of the Marani Fetal Monitoring Telehealth System (M•care™ System) for use in antenatal monitoring of pregnant women ≥ 32 weeks’ gestation. The M•care System will be evaluated by comparing Fetal Heart Rate (FHR), Maternal Heart Rate (MHR) and Uterine Contractions (UC) to Doppler FHR, tocodynamometer (TOCO) UC, and Pulse Oximeter MHR measured with an FDA cleared standard of care cardiotocography (CTG) device.
This is a multi-center, single arm, prospective paired comparison trial to determine the equivalence of the Marani M•care System with an FDA cleared Doppler FHR, TOCO UC and Pulse Oximetry MHR standard of care CTG device.
The expected monitoring duration for each subject is a minimum of 60 minutes and maximum of 120 minutes.
Marani Health’s M•care System is a fetal heart rate (FHR), maternal heart rate (MHR), and uterine activity (UA) monitoring system intended for home use by a pregnant woman as prescribed by their healthcare provider.
The M•care™ System is comprised of 3 components:
(1) The M•wrap™, a wearable compression abdominal band with an integrated electronics hub, called the M•core™, mounted to the garment, that interfaces with
(2) the removable Orbital Research SilverBump dry electrodes and
(3) mobile and web-based software applications to securely transmit subject vital data to secure systems
Owing to the unique placement of electrodes within the M•wrap, the functionality of the system is not dependent on fetal position.
The M-care System is being developed In accordance with the requirements of FDA’s Quality System Regulation for Medical Devices, 21CFR Part 820, and ISO13485:2016 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes. Both FDA and ISO13485 mandate the use of Design Controls to ensure a formalized approach to development of medical devices. Marani Health has established Design Control procedures to ensure that a robust, and uniform product development methodology is being followed. This methodology includes, but is not limited to, the following requirements:
- Design and Development Plans are established, reviewed, updated, and approved.
- • Design Inputs are identified to ensure that design requirements are appropriate and address the intended use.
- • Design Outputs are defined to allow for adequate evaluation of conformance to design inputs.
- • Design Reviews are planned and conducted at appropriate stages during development.
- • Design Verification is performed to ensure the design output meets the design input requirements.
- • Design Validation is performed to confirm that devices conform to defined user needs and intended uses under actual or simulated use conditions.
The output of these activities is maintained in a Design History File in Marani Health’s Quality Management System.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Able to provide Informed Consent and follow study instructions.
- 18 years of age or older.
- Pregnant subjects ≥ 32 weeks’ gestation.
- Singleton pregnancy.
- BMI ≥ 15, pre-pregnancy.
- BMI ≤ 45, pre-pregnancy.
- Belly circumference ≥ 80 cm and ≤ 130 cm.
- NOTE: Subjects admitted for induction of labor and subjects being monitored for premature rupture of membranes (PROM) or other inpatient evaluations can be enrolled in the trial.
Exclusion Criteria:
- Known major fetal malformation or chromosome abnormality.
- Medical or obstetric problem that would preclude the use of abdominal electrodes (e.g., skin eruptions, history of sensitivity to silver).
- Subjects with implanted electronic devices (pacemakers, defibrillator, etc.).
- Involvement in another clinical trial currently or previously in this pregnancy that, in the investigator's opinion, would affect the conduct of this study.
- Medical or obstetric problem that in investigator's opinion would make the subject incapable of taking part in the study.
- In the investigator’s opinion, the subject is not likely to be available for the minimum 60 minutes of the monitoring session.
- Subjects with any skin abnormalities (rash, abrasions, etc.) in the region where the M•wrap will be placed.
Eligibility last updated 1/17/22. Questions regarding updates should be directed to the study team contact.
More information
Publications
Publications are currently not available