Clinical Trials

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.

The purpose of this study is to determine whether initiating breathing assistance prior to clamping the umbilical cord influences the occurrence of intraventricular (brain) hemorrhage in extremely preterm infants, compared to the standard care of starting ventilation assistance after cord clamping.

The purpose of this study is to compare the length of pre-delivery hospitalization in women undergoing outpatient Foley catheter versus inpatient cervical ripening for induction of labor.

The purpose of this project will examine the feasibility of offering whole genome sequencing (WGS), and developing a Rapid WGS protocol, for a fetus or neonate with multiple anomalies.

The purpose of this study is to determine the time from intramuscular injection to the time of first fetal movement after a fetal surgery procedure.

The purposes of this study are to determine whether maternal T cells are activated and expand after in utero intervention, and to determine whether placental macrophages and histology in the maternal-fetal interface exhibit increased activation and inflammation in surgical cases born preterm (<37 _weeks29_="" compared="" to="" />

The purpose of this study is to form a registry of data on the long term physical and mental health outcomes of the mother and child following fetal surgical repair for spina bifida.

The purpose of this study is to investigate the microbial, protein, genetic and cell profiles of the tracheal aspirates and amniotic fluid in human fetuses with congenital diaphragmatic hernia that undergo fetal therapy.

The postnatal diagnosis of Long QT Syndrome (LQTS) is suggested by a prolonged QT interval on 12 lead electrocardiogram (ECG),a positive family history and/or characteristic arrhythmias and confirmed by genetic testing.  LQTS testing cannot be performed successfully before birth as   fetal ECG is not possible and direct measure of the fetal QT interval by magnetocardiography is limited. Genetic testing can be performed in utero, but there is risk to the pregnancy and the fetus. Although some fetuses present with arrhythmias easily recognized as LQTS (torsade des pointes (TdP) and/or 2° atrioventricular (AV) block, this is uncommon, occurring in <25% of fetal LQTS cases. Rather, the most common presentation of fetal LQTS is sinus bradycardia, a subtle rhythm disturbance that often is unappreciated to be abnormal. Consequently, the majority of LQTS cases are unsuspected and undiagnosed during fetal life, with dire consequences. For example, maternal medications commonly used during pregnancy can prolong the fetal QT interval and may provoke lethal fetal ventricular arrhythmias. But the most significant consequence is the missed opportunity for primary prevention of life threatening ventricular arrhythmias after birth because the infant is not suspected to have LQTS before birth. The over-arching goal of the study is to overcome the barriers to prenatal detection of LQTS. The investigators plan to do so by developing an algorithm using fetal heart rate (FHR) which will discriminate fetuses with or without LQTS. Immediate Goal: The investigators propose a multicenter pre-birth observational cohort study to develop a Fetal Heart Rate (FHR)/Gestational Age (GA) algorithm from a cohort of fetuses recruited from 13 national and international centers where one parent is known by prior genetic testing to have a mutation in one of the common LQTS genes: potassium voltage-gated channel subfamily Q member 1 (KCNQ1), potassium voltage-gated channel subfamily H member 2 (KCNH2), or sodium voltage-gated channel alpha subunit 5 (SCN5A). The investigators have chosen this population because 1) These mutations are the most common genetic causes of LQTS, and 2) Offspring will have high risk of LQTS as inheritance of these LQTS gene mutations is autosomal dominant. Thus, progeny of parents with a known mutation are at high (50%) risk of having the same parental LQTS mutation. The algorithm will be developed using FHR measured serially throughout pregnancy. All offspring will undergo postnatal genetic testing for the parental mutation as the gold standard for diagnosing the presence or absence of LQTS.

The aim of this study is to describe how kicking frequency and complexity differs over developmental time between typically developing infants, infants with SB who have had prenatal repair of their spinal lesion, and infants with SB who have had postnatal repair.