Remote Pregnancy Monitoring to Improve Access (REACTIVE)

University of Pennsylvania

Status: Active, not recruiting

Conditions: Fetal Monitoring

Treatments: Other: Standard of care; Device: Invu monitoring belt

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05847790

852291

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Remote NST

Experimental group

Treatment:

Device: Invu monitoring belt

In-clinic NST - Standard of Care

Active Comparator group

Treatment:

Other: Standard of care