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Completed
NCT05847790
Remote Pregnancy Monitoring to Improve Access
Conditions: Fetal Monitoring
Sex: Female
Healthy volunteers: No
Phase: NA
Enrollment: 400
Sponsor: University of Pennsylvania
Location: University of Pennsylvania Philadelphia Pennsylvania
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 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
Source: ClinicalTrials.gov (NCT05847790). StuddyBuddy aggregates publicly available trial information.