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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

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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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.
  • Participant was monitored in the intrapartum period in the Oli Pilot Study (ETH00410).
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: Female

    Things to know

    Study dates

    Study start: 2025-01-28

    Primary completion: 2026-03-31

    Study completion finish: 2026-04-30

    study type

    Study type

    DIAGNOSTIC

    phase

    Phase

      NA

    trial

    Trial ID

    NCT06655207

    Intervention or treatment

    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

    Conditions

    • Post Partum Haemorrhage
    • Maternal Care Patterns
    • High Risk Pregnancy
    Image related to Post Partum Haemorrhage
    • Condition: Post Partum Haemorrhage, Maternal Care Patterns and more

    • 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

    • St Leonards, New South Wales, Australia and more

    • Sponsor: Baymatob Operations Pty Ltd

    Find a site

    Closest Location:

    Royal North Shore Hospital

    Research sites nearby

    Select from list below to view details:

    • Royal North Shore Hospital

      St Leonards, New South Wales, Australia

    • Royal Hospital for Women

      Randwick, New South Wales, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    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 hourNot Specified6 months
    To assess the performance of Oli in cumulative blood loss ≥ 1000ml (ACOG)Not Specified14 months

    Secondary outcome

    Frequently Asked Questions

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    References

    Clinical Trials Gov: 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

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