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. The PregnaOne System consists of the Pregnabit Pro device and related software, designed to record fetal heart rate, maternal pulse, and uterine contractions in a home-like environment. The study compares the performance of the PregnaOne System with a similar FDA-cleared at-home monitoring system (the INVU system by Nuvo). Approximately 70 pregnant women will participate at three medical centers in the United States. Each participant will complete one training session and two fetal monitoring sessions during a single study visit.

Inclusion Criteria: * Able to independently read and understand written and spoken English and willing to provide written informed consent and comply with all instructions required by the study protocol. * Female aged 22 years or older. * Estimated gestational age between 32 and 41 weeks. * Singleton gestation. * Pre-pregnancy or first prenatal visit BMI \< 40 kg/m². * Able and willing to undergo fetal monitoring sessions in a simulated home environment at the study site. * Women who do not meet the gestational age criterion at the screening visit but will meet it by the study visit (within two weeks) may be enrolled. Exclusion Criteria: * In active labor or in the delivery room during labor. * Requires hospitalization or life support. * Any contraindications for cardiotocography (CTG) monitoring. * Severe hypertension (≥160/110 mmHg measured twice, 15 minutes apart). * Known allergy to latex, ultrasound (US) gel, or ECG gel. * Skin conditions (e.g., edema, erythema, irritation, infection, lesions, or open wounds) at contact points for the Pregnabit Pro or comparator devices. * Implanted electronic devices (e.g., pacemaker, stimulator, defibrillator, pump). * Members of vulnerable populations other than pregnant women (e.g., minors, wards of the state, cognitively impaired individuals, prisoners, or institutionalized persons).