Pivotal, Prospective, Multi-centre, Single-arm Study to Evaluate the Safety and Effectiven
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 haemorrhag
| Condition(s) | Post Partum Haemorrhage, Maternal Care Patterns, High Risk Pregnancy |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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. |
| Ages | 18 Years |
| Sex | Female |
| Lead sponsor | Baymatob Operations Pty Ltd |
| Locations | Denver, Colorado, United States; Baton Rouge, Louisiana, United States; New York, New York, United States; Columbus, Ohio, United States; Pittsburgh, Pennsylvania, United States; Randwick, New South Wales, Australia (+1 more sites) |
| Start date | 2025-08-06 |
| NCT ID | NCT06655207 |
| Official listing | https://clinicaltrials.gov/study/NCT06655207 |