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Wearable patch could warn of deadly Post-Birth bleeding an hour before it happens

NCT ID NCT06655207

Diagnosis Sponsor: Baymatob Operations Pty Ltd 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This trial tests a non-invasive wearable device called Oli, placed on the abdomen during labor, that aims to predict if a person is at higher risk of severe bleeding (postpartum hemorrhage) after giving birth. The device is designed to alert doctors at least one hour before delivery, allowing time to prepare. The study enrolls 1000 pregnant people planning a vaginal delivery and measures how well Oli predicts blood loss of 500 mL or more.

What this could mean

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

Active substance
Oli wearable device
What this could lead to
If effective, Oli could give doctors a 1-hour advance warning of dangerous postpartum bleeding, potentially saving lives and reducing emergency interventions.
What could go wrong
This is a single-arm study with 1000 participants, so results may not apply to all birthing situations. The device's accuracy and real-world usefulness are still being tested.

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

1,000 people

The number who actually took part.

Started

Aug 2025

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * \>18 years of age * Provision of informed consent i.e. participant must be able to understand and sign the Participant Information and Consent Form * ≥28 weeks gestation * Planning for normal vaginal delivery (participants requiring emergency caesarean delivery will not be excluded) Exclusion Criteria: * Currently participating in an investigational study that in the Investigator's opinion makes it undesirable to participate in this trial. * Known significant sensitive skin or allergy/hypersensitivity to the medical gel/adhesive used to adhere the electrodes to the body * Any concurrent condition which in the Investigator's opinion makes it undesirable for the participant to participate in the trial or which would jeopardize compliance with the protocol or follow up. * Participant was monitored in the intrapartum period in the Oli Pilot Study (ETH00410).

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Conditions

The condition(s) this trial relates to.

Postpartum Hemorrhage

As listed by the trial registrant

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

High-risk pregnancy Maternal care patterns Post partum haemorrhage

Contacts and locations

Locations

  • Columbia University Irving Medical Center

    New York, New York, 10032, United States

  • Royal Hospital for Women

    Randwick, New South Wales, 2031, Australia

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065, Australia

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • UC Health University of Colorado Hospital

    Denver, Colorado, 80045, United States

  • UPMC Magee Womens Hospital

    Pittsburgh, Pennsylvania, 15213, United States

  • Woman's Hospital

    Baton Rouge, Louisiana, 70817, United States

More trials for these conditions

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