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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

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

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.

Country

City, postcode or hospital

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

Other trials in United States

Australia2 sites

Royal Hospital for Women
Randwick, New South Wales, 2031
Royal North Shore Hospital
St Leonards, New South Wales, 2065

Other trials in Australia

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.

Conditions: Post Partum Haemorrhage, Maternal Care Patterns, High Risk Pregnancy
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 groups in NCT06655207
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.

6 Aug 20253 Jul 2026

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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