Remote Pregnancy Monitoring to Improve Access

University of Pennsylvania400 enrolled

Overview

The goal of this clinical trial is to determine the effectiveness of remote nonstress test (NST) compared to in-clinic NSTs in improving fetal testing completion rates. Participants will be randomized to either in-clinic NSTs or use of an FDA-approved remote monitoring belt for their pregnancy monitoring.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

400

Conditions

Fetal Monitoring

Interventions

Invu monitoring beltDEVICE

INVU monitoring belt used for remote NSTs

Standard of careOTHER

In-clinic NSTs - standard of care

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

Inclusion Criteria: * Singleton pregnancy * Gestational age between 30 weeks 0 days and 35 weeks 6 days * Pregnant patients who have clinical indication for fetal surveillance with NSTs (based on UPHS Health System clinical guidelines for antenatal monitoring) * Able to provide written consent * English speaking Exclusion Criteria: * Multiple gestations * Maternal pre-gravid BMI greater than 45kg/m2 * Presence of an implanted pacemaker or defibrillator * Active abdominal skin infection * A known amniotic fluid index (AFI) less than 5cm or greater than 25cm on the most recent ultrasound (if available) prior to randomization * Delivery is planned within 2 weeks of potential randomization

Locations (1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Overall Fetal Testing Completion Rate

percentage of recommended antenatal testing sessions that were successfully completed as defined as a clinically interpreted test was performed