Remote Pregnancy Monitoring to Improve Access

Phase

N/A

Condition

Labor/delivery

Treatment

Invu monitoring belt

Standard of care

Clinical Study ID

NCT05847790

852291

Female

Study 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.

Eligibility Criteria

Inclusion

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

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 mostrecent ultrasound (if available) prior to randomization
Delivery is planned within 2 weeks of potential randomization

Study Design