Head of Product Development Baymatob Operations Pty Ltd Leichhardt, New South Wales, Australia
Introduction: A non-invasive device known as Oli™ has been granted FDA Breakthrough Device Designation to identify individuals at risk of abnormal postpartum uterine bleeding, including postpartum hemorrhage (PPH), at least one hour before birth. This publication offers an initial assessment of feasibility and performance of this claim. Methods: An IRB approved study saw the Oli device attached to pregnant participants, of gestation greater than or equal to 36-weeks, during labor. Oli data measured during this time were analysed retrospectively to assess whether there was a prediction of abnormal postpartum uterine bleeding including PPH at least one hour before birth for the monitored individuals. This was checked against the health record and leave one out cross validation was used to determine performance. Results: Data from a total of 49 participants were reviewed as part of this analysis. Of these 44 met the criteria for analysis. Results showed that the Oli device was able to identify individuals at risk of abnormal postpartum uterine bleeding including PPH at least one hour before birth with sensitivity of 80% and specificity of 97%. Conclusion/Implications: This initial analysis showed the feasibility of the Oli device to identify individuals at risk of abnormal postpartum uterine bleeding including PPH at least one hour before birth. This is of significant value noting PPH is a retrospective diagnosis. Earlier identification of women at risk provides an ability to switch from a reactive response after heavy blood loss to a proactive mode, potentially improving maternal outcomes. Next steps are to apply analysis to larger datasets.
