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

NCT06655207 | Recruiting

• 1 other identifier: OLIPPH-CI-2201
• Study Type: interventional
• Target: 1,000
• Locations: 2 countries
• Sites: 7

Brief Summary

Oli is a predictive, non-invasive device, intended to be placed on the participant's maternal abdomen during the intrapartum period, which can alert healthcare professionals of an impending cumulative blood loss of ≥500 ml (abnormal postpartum uterine bleeding) or cumulative blood loss of ≥1000ml (postpartum haemorrhage) at least 1 hour in advance of birth. This study is being undertaken to assess the performance of Oli measuring cumulative blood loss ≥500ml and ≥1000ml, as well as evaluate its safety profile.

Conditions

Post Partum Haemorrhage; Maternal Care Patterns; High Risk Pregnancy

Keywords

Pivotal Study; Single arm; prospective

Outcome Measures

Primary Outcomes (2)

• Assess the performance of Oli as calculated by comparing the output of Oli (up to 1 hour prior to birth) against the clinically documented value of cumulative blood loss ≥ 500ml or any blood loss with signs and/or symptoms of hypovolemia within 24 hour

  6 months

• To assess the performance of Oli in cumulative blood loss ≥ 1000ml (ACOG)

  14 months

Interventions

Oli is a non-invasive, wearable device, designed to provide clinicians with an early indication if the participant is at a higher risk of developing abnormal postpartum uterine bleeding DEVICE

Oli is a non-invasive wearable device, designed to provide clinicians with an early indication if the participant is at a higher risk of developing abnormal postpartum uterine bleeding, including postpartum haemorrhage.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant females
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Baymatob Operations Pty Ltd: lead
• Royal North Shore Hospital: collaborator
• Royal Hospital For Women: collaborator

Study Sites (7)

UC Health University of Colorado Hospital

Denver, Colorado, 80045, United States

NOT YET RECRUITING

Woman's Hospital

Baton Rouge, Louisiana, 70817, United States

NOT YET RECRUITING

Columbia University Irving Medical Center

New York, New York, 10032, United States

NOT YET RECRUITING

The Ohio State University

Columbus, Ohio, 43210, United States

NOT YET RECRUITING

UPMC Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

NOT YET RECRUITING

Royal Hospital for Women

Randwick, New South Wales, 2031, Australia

NOT YET RECRUITING

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

RECRUITING

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Wearable Electronic Devices

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Central Study Contacts

Bernadette Pickering

CONTACT

+61 (2) 9871 7412; bernadette.pickering@baymatob.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 23, 2024
• Study Start: August 6, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

AU (2); US (5)