Post Partum HaemorrhageNCT06655207
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
A study testing 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 people with Post Partum Haemorrhage and Maternal Care Patterns, run by Baymatob Operations Pty Ltd at 7 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post Partum Haemorrhage, Maternal Care Patterns, High Risk Pregnancy
- What is being tested?
- 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 6 Aug 2025to 3 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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)
Who cannot join
- 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).
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States5 sites
Woman's Hospital
Baton Rouge, Louisiana, 70817
The Ohio State University
Columbus, Ohio, 43210
UC Health University of Colorado Hospital
Denver, Colorado, 80045
Columbia University Irving Medical Center
New York, New York, 10032
UPMC Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213
Australia2 sites
Royal Hospital for Women
Randwick, New South Wales, 2031
Royal North Shore Hospital
St Leonards, New South Wales, 2065
About this study
Official title: 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
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.
Read the detailed description
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.
- Being tested
- 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
- Keywords
- Pivotal Study, Single arm, prospective
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 bleedingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Single arm study | Other | Standard of care Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
To assess the performance of Oli in cumulative blood loss ≥ 1000ml (ACOG)
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start6 Aug 2025
- Primary completion26 Jun 2026
- Study completion3 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Partum HaemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baymatob Operations Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Royal North Shore Hospital, Royal Hospital For Women
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655207
- Sponsor's protocol ID
- OLIPPH-CI-2201
- Status last verified
- Jun 2026
- First submitted
- 22 Oct 2024
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06655207
- Acronym / sponsor ID
- OLIPPH-CI-2201
- Keywords
- Pivotal Study, Single arm, prospective
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Baymatob Operations Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Royal North Shore Hospital, Royal Hospital For Women
- Study start
- 6 Aug 2025 (actual)
- Primary completion
- 26 Jun 2026 (actual)
- Study completion
- 3 Jul 2026 (estimated)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm study | Other | 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 bleedingStandard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >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)
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 bleedingOli 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. | Device | Single arm study |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 people with Post Partum Haemorrhage and Maternal Care Patterns, run by Baymatob Operations Pty Ltd at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.