Remote Pregnancy Monitoring to Improve Access

NCT05847790 | Completed DMC FDA Device

• 1 other identifier: 852291
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fetal Monitoring

Keywords

Fetal monitoring; antenatal testing

Outcome Measures

Primary Outcomes (2)

• Overall Fetal Testing Completion Rate

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

  from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.

• Fetal Testing Completion Rate in Black versus non-Black subjects

  Comparison between Black and non-Black subjects' percentage of recommended antenatal testing sessions that were successfully completed as defined as a clinically interpreted test was performed.

  from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.

Secondary Outcomes (24)

• Fetal Monitoring outcomes: Number of visits to the antenatal testing unit

  from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.

• Fetal Monitoring outcomes: Frequency of provider recommended prolonged monitoring

  from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.

• Fetal Monitoring outcomes: Time on NST monitor

  from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.

• Fetal Monitoring outcomes: Number of non-reactive NSTs

  from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.

• Fetal Monitoring outcomes: Number of biophysical profiles performed for non-reactive NST tests

  from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.

Study Arms (2)

Remote NST

EXPERIMENTAL

Device: Invu monitoring belt

In-clinic NST - Standard of Care

ACTIVE COMPARATOR

Other: Standard of care

Interventions

Invu monitoring belt DEVICE

INVU monitoring belt used for remote NSTs

Remote NST

Standard of care OTHER

In-clinic NSTs - standard of care

In-clinic NST - Standard of Care

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of OBGYN

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 8, 2023
• Study Start: May 25, 2023
• Primary Completion: September 26, 2025
• Study Completion: September 26, 2025
• Last Updated: October 30, 2025

Record last verified: 2025-05

Locations

US (1)