Wearable device (Oli) on the abdomen to warn of high risk of heavy bleeding after birth

Pivotal, Prospective, Multi-centre, Single-arm Study to Evaluate the Safety and Effectiveness of Oli for Identification of Patients, During the Intrapartum Period, Who Are at Higher Risk of Developing Abnormal Postpartum Uterine Bleeding, Including Postpartum Haemorrhage, in Advance of Delivery/Birth

This tests a wearable, non-invasive device placed on your abdomen during labor to see if it can warn clinicians at least an hour before heavy postpartum bleeding (≥500 ml) or a hemorrhage (≥1000 ml).

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Baymatob Operations Pty Ltd (Industry-sponsored)
• Locations: 7 sites (Denver, Colorado and 6 other locations)
• Trial ID: NCT06655207 on ClinicalTrials.gov

What this trial studies

This is a pivotal, prospective, multi-center, single-arm study of Oli, a non-invasive wearable placed on the maternal abdomen during the intrapartum period. The device uses multiple physiological parameters to predict cumulative blood loss of ≥500 ml (abnormal postpartum uterine bleeding) or ≥1000 ml (postpartum hemorrhage) and is designed to alert clinicians at least one hour before birth. The trial enrolls people ≥28 weeks gestation planning vaginal delivery across several U.S. hospitals and compares device alerts to measured blood loss and clinical outcomes. Safety monitoring includes skin reaction checks and recording any device-related adverse events.

Who should consider this trial

Good fit: People aged 18 or older at ≥28 weeks gestation who can give informed consent and are planning a vaginal delivery (with emergency cesarean not automatically excluded) are the intended participants.

Not a fit: Those with known allergy or significant sensitivity to the device adhesive, participants currently in conflicting investigational trials, or people with concurrent conditions that make participation unsafe or noncompliant may not receive benefit.

Why it matters

Potential benefit: If successful, Oli could give clinicians earlier warning of heavy postpartum bleeding, enabling faster treatment and potentially reducing severe hemorrhage and related complications.

How similar studies have performed: This approach is relatively novel but a prior Oli pilot study and an FDA Breakthrough Device designation provide preliminary supportive evidence.

Eligibility criteria

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).

Where this trial is running

Denver, Colorado and 6 other locations

• UC Health University of Colorado Hospital — Denver, Colorado, United States (Not_yet_recruiting)
• Woman's Hospital — Baton Rouge, Louisiana, United States (Not_yet_recruiting)
• Columbia University Irving Medical Center — New York, New York, United States (Not_yet_recruiting)
• The Ohio State University — Columbus, Ohio, United States (Not_yet_recruiting)
• UPMC Magee Womens Hospital — Pittsburgh, Pennsylvania, United States (Not_yet_recruiting)
• Royal Hospital for Women — Randwick, New South Wales, Australia (Not_yet_recruiting)
• Royal North Shore Hospital — St Leonards, New South Wales, Australia (Recruiting)

Study contacts

• Study coordinator: Bernadette Pickering

Conditions Post Partum Haemorrhage; Maternal Care Patterns; High Risk Pregnancy; Pivotal Study; Single arm; prospective