CompletedNot Applicable

Remote Pregnancy Monitoring to Improve Access

United States400 participantsStarted 2023-05-25

Plain-language 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.

Who can participate

SexFEMALE

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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

What they're measuring

Overall Fetal Testing Completion Rate

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

Fetal Testing Completion Rate in Black versus non-Black subjects

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

Trial details

NCT IDNCT05847790

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-26

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