Remote Pregnancy Monitoring to Improve Access

NCT ID: NCT05847790

Last Updated: 2025-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-25

Study Completion Date

2025-09-26

Brief Summary

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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.

Detailed Description

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Conditions

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Fetal Monitoring

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Remote NST

Group Type EXPERIMENTAL

Invu monitoring belt

Intervention Type DEVICE

INVU monitoring belt used for remote NSTs

In-clinic NST - Standard of Care

Group Type ACTIVE_COMPARATOR

Standard of care

Intervention Type OTHER

In-clinic NSTs - standard of care

Interventions

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Invu monitoring belt

INVU monitoring belt used for remote NSTs

Intervention Type DEVICE

Standard of care

In-clinic NSTs - standard of care

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Samuel Parry, MD

Professor of OBGYN

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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852291

Identifier Type: -

Identifier Source: org_study_id

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