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Could pregnant patients skip clinic visits and monitor their baby from home?

NCT ID NCT06741735

Knowledge-focused Sponsor: University of Missouri-Columbia Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers are studying whether a remote fetal monitoring system called INVU can let pregnant patients do their weekly non-stress tests at home instead of in a clinic. The trial enrolls about 110 English-speaking adults in Missouri who are 32 to 40 weeks pregnant with a single baby and need antenatal testing for reasons such as gestational diabetes, chronic hypertension, or advanced maternal age. Participants are randomly assigned to at-home or in-clinic testing and answer surveys before and after to measure patient and provider satisfaction and cost savings.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
INVU fetal monitoring system, a device that lets pregnant patients do non-stress tests at home
What this could lead to
If it works, pregnant patients who need weekly fetal monitoring could do those tests from home instead of traveling to a clinic, which may save time and money.
What could go wrong
This is a small study at three centers, and it measures satisfaction and costs rather than whether at-home monitoring improves pregnancy outcomes. Home monitoring may not suit every patient or catch problems as reliably as in-clinic testing.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * English Speaking * \> 18 years of age * Singleton gestation * Missouri Medicaid as primary insurance (paid by study), offered to patients with private insurance for self-pay * Requires antenatal testing between 32-40 weeks according to institutional policies * One of the following indications for fetal NST: * Gestational diabetes * Well-controlled type II diabetes * Chronic hypertension without evidence of placental insufficiency * Advanced maternal age * Obesity (as defined as BMI \>30 and \<45) * Android or iOS system-operated telephone or tablet * Home or work access to reliable internet (WIFI screening completed by research personnel) Exclusion Criteria * Multiple gestations * Additional co-morbidities not listed in the inclusion criteria * PPROM or evidence of preterm labor * Oligohydramnios of \< 5 cm of polyhydramnios \> 30 * Co-existing fetal complications: FGR, placenta or vasa previa, fetal chromosomal or structural anomaly, recent (within a week) fetal testing of a BPP \< 8/10 prior to enrollment * Intention to transfer care to different provider during the pregnancy * Currently institutionalized or incarcerated * Inability to consent for oneself * \<18 years of age * History of prior stillbirth * Lack of access to reliable internet * Abdominal skin disorder that prevents use of the INVO device

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As listed by the trial registrant

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Pregnancy

How to take part

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  2. The places running it

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Contacts and locations

Locations

  • University of Missouri

    RECRUITING

    Columbia, Missouri, 65212, United States

    Contact Email: •••••@•••••

  • University of Missouri - Kansas City

    RECRUITING

    Kansas City, Missouri, 64111, United States

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