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
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
Baymatob Operations Pty Ltd
1,000 participants
Aug 6, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- >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 Criteria4
- 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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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, including postpartum haemorrhage.
Locations(7)
View Full Details on ClinicalTrials.gov
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NCT06655207