Actively Recruiting
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
Led by Baymatob Operations Pty Ltd · Updated on 2025-08-08
1000
Participants Needed
7
Research Sites
51 weeks
Total Duration
On this page
Sponsors
B
Baymatob Operations Pty Ltd
Lead Sponsor
R
Royal North Shore Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants 18 years of age or older
- Pregnant individuals at 28 weeks gestation or more
- Ability to understand and sign informed consent
- Planning for normal vaginal delivery (emergency cesarean not excluded)
You will not qualify if you...
- Currently in another investigational study that could interfere with this trial
- Known significant sensitive skin or allergy to medical gel/adhesive used for electrodes
- Any condition making participation or compliance undesirable or unsafe as judged by the investigator
- Participants previously monitored in the Oli Pilot Study (ETH00410)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
UC Health University of Colorado Hospital
Denver, Colorado, United States, 80045
Not Yet Recruiting
2
Woman's Hospital
Baton Rouge, Louisiana, United States, 70817
Not Yet Recruiting
3
Columbia University Irving Medical Center
New York, New York, United States, 10032
Not Yet Recruiting
4
The Ohio State University
Columbus, Ohio, United States, 43210
Not Yet Recruiting
5
UPMC Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
Not Yet Recruiting
6
Royal Hospital for Women
Randwick, New South Wales, Australia, 2031
Not Yet Recruiting
7
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
Actively Recruiting
Research Team
B
Bernadette Pickering
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
0
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