An interventional study of 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 in Post Partum Haemorrhage, Maternal Care Patterns and High Risk Pregnancy, sponsored by Baymatob Operations Pty Ltd. Active, not recruiting at 7 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by Baymatob Operations Pty Ltd · Not applicable, Interventional, and Diagnostic
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.
The World Health Organization (WHO) recognizes postpartum haemorrhage as a blood loss of 500ml or more within 24 hours after delivery and severe PPH as a blood loss of 1000ml within the same timeframe [2]. The American College of Obstetricians and Gynaecologists (ACOG) defines PPH as a cumulative blood loss of greater than or equal to 1000ml or blood loss accompanied by signs and symptoms of hypovolemia within 24 hours after the birth process [7] and recognizes a blood loss greater than 500ml as abnormal, and should be treated as a Stage 1 Obstetric Haemorrhage [17]. Further, the CMQCC Obstetric Haemorrhage Care Guidelines identifies a blood loss greater than 500ml as the trigger for the activation of haemorrhage protocols [18]. The Royal Australin and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) also recognises postpartum haemorrhage as a blood loss of 500ml or more within 24 hours after delivery [26]. Consistent with these standards, Baymatob for the purpose of this study has defined Abnormal Postpartum Uterine Bleeding as postpartum blood loss ≥ 500ml.
Oli is a non-invasive device that uses several different parameters to identify those individuals who are likely to experience an APUB, including PPH, prior to birth. Oli has been granted FDA Breakthrough Device Designation for use by healthcare providers to identify a patient, during the intrapartum period, who is at higher risk of developing abnormal postpartum uterine bleeding, including postpartum haemorrhage, in advance of delivery/birth.
Oli functions by capturing physiological signals (a combination of biopotentials, skin temperature, movement and deformation of the maternal abdomen) via a wearable sensor attached to the maternal abdomen by electrodes during the intrapartum period. The physiological signals are processed and analysed via a fixed machine learning algorithm against a pre-defined threshold that indicates whether an individual is at an increased risk of APUB including PPH occurring.
445 studies on the registry are indexed under Postpartum Hemorrhage; 75 are open to participants now.
This study's enrollment of 1,000 is above the median of 148 across 340 interventional studies indexed under Postpartum Hemorrhage.
Browse Postpartum Hemorrhage studies →This is the only study on the registry with Baymatob Operations Pty Ltd as lead sponsor.
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Exclusion Criteria:
Standard of care
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
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.
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
Time frame: 6 months
To assess the performance of Oli in cumulative blood loss ≥ 1000ml (ACOG)
Time frame: 14 months
Plan to share: Undecided
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This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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