Remote Pregnancy Monitoring to Improve Access

Last updated: May 30, 2024
Sponsor: University of Pennsylvania
Overall Status: Active - Recruiting

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

Total Participants: 400
Treatment Group(s): 2
Primary Treatment: Invu monitoring belt
Phase:
Study Start date:
May 25, 2023
Estimated Completion Date:
May 31, 2025

Connect with a study center

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

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