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Smart patch watches new moms for danger signs after C-Section

NCT ID NCT04060667

Disease control Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jul 24, 2026 · Updated 2 times

Summary

This study tests whether a wireless monitor worn for 24 hours after an emergency C-section can alert doctors when a new mother's vital signs become dangerous. Over 3,000 women in Uganda will wear the device, which sends alerts if heart rate, blood pressure, or other readings fall outside safe ranges. The goal is to see if this early warning system can reduce severe complications like hemorrhage, organ failure, or death.

What this could mean

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

Active substance
wireless physiologic monitor
What this could lead to
If successful, this could provide a simple way to catch life-threatening complications early after childbirth, potentially saving lives in low-resource settings.
What could go wrong
This is an early-stage study focused on monitoring, not treatment. The device may not reduce severe outcomes, and results may not apply to other hospitals or populations.

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

3,191 people

The number who actually took part.

Started

Jan 2020

Finished

Dec 2024

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

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Emergency cesarean delivery at MRRH * Able to provide consent or have a guardian/attendant present who can consent * Willing to wear the biosensor for 24 hours * Willing remain in the postpartum unit for 24 hours Exclusion Criteria: * Admitted to ICU directly after delivery * Allergies or hypersensitivity to device materials

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Conditions

The condition(s) this trial relates to.

Maternal Death pregnancy disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Maternal death during childbirth Pregnancy complications

Contacts and locations

Locations

  • Mbarara Regional Referral Hospital

    Mbarara, Uganda

More trials for these conditions

Other studies related to the condition(s) this trial covers.