Use of In-Home Non-Stress Monitoring Device for Fetal Monitoring: A Nonsignificant Risk (NSR) Device Study

Inclusion Criteria

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).