Oli for Postpartum Hemorrhage

Recruiting at 6 trial locations

Overseen By Bernadette Pickering

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Baymatob Operations Pty Ltd

Disqualifiers: Sensitive skin, Allergy, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called Oli, designed to predict and alert doctors about heavy bleeding after childbirth. It aims to provide a warning at least an hour before significant blood loss occurs, helping to prevent complications. The trial seeks to evaluate Oli's effectiveness and ensure its safety. This trial might be suitable for those at least 28 weeks pregnant, planning a vaginal delivery, and able to give informed consent.

As an unphased trial, participation contributes to innovative research that could improve maternal health outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that this device is safe for postpartum hemorrhage prediction?

Research shows that Oli is a non-invasive device designed to help predict excessive bleeding after childbirth, known as postpartum hemorrhage. Placed on the mother's abdomen, it alerts healthcare professionals if there is a risk of significant blood loss after birth.

Regarding safety, Oli, being a device and not a medication, does not carry the same risk of side effects as drugs. The device is wearable and non-invasive, making it generally easy to tolerate. Available information reports no negative effects directly linked to its use.

The study aims to evaluate Oli's effectiveness and confirm its safety for mothers. The trial is not in its early stages, indicating some existing understanding of its safety. These points can help prospective participants understand the device's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Oli is unique because it offers a new approach to treating postpartum hemorrhage, a condition traditionally managed with uterotonics like oxytocin and misoprostol. Unlike these standard treatments, which primarily stimulate the uterus to contract, Oli might work through a different mechanism or delivery method, potentially improving effectiveness or safety. Researchers are excited about Oli because it could provide a more targeted or efficient solution, addressing some limitations of current therapies and improving outcomes for new mothers.

What evidence suggests that this device is effective for predicting postpartum hemorrhage?

Research has shown that early detection tools can be vital in reducing severe bleeding after childbirth. Some technologies have shown promise in predicting postpartum hemorrhage (PPH), with severe bleeding reduced by 60% in certain studies. Predictive models also identify risks before they become serious. This trial studies the Oli device, designed to alert healthcare professionals to potential excessive blood loss before it occurs, which could greatly aid in managing and preventing PPH. This proactive approach could save lives by providing medical teams with an early warning to act quickly. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for pregnant individuals at least 28 weeks into gestation, planning a normal vaginal delivery, and able to give informed consent. It's not for those requiring emergency caesarean delivery before labor or who cannot sign the consent form.

Inclusion Criteria

I am currently in labor.

I am more than 36 weeks pregnant.

I understand and have signed the consent form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intrapartum Monitoring

Oli device is placed on the participant's maternal abdomen to monitor physiological signals and predict abnormal postpartum uterine bleeding

During intrapartum period

Follow-up

Participants are monitored for safety and effectiveness after the use of the Oli device

24 hours post-delivery

What Are the Treatments Tested in This Trial?

Interventions

• Oli

Trial Overview The study tests Oli, a non-invasive device placed on the abdomen during childbirth that predicts significant blood loss (≥500ml) up to an hour before it happens. The goal is to assess its accuracy in predicting abnormal bleeding and postpartum hemorrhage.

How Is the Trial Designed?

Group I: Single arm study Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Baymatob Operations Pty Ltd

Lead Sponsor

Trials

1

Recruited

1,000+

Royal Hospital For Women

Collaborator

Trials

6

Recruited

1,600+

Royal North Shore Hospital

Collaborator

Trials

42

Recruited

7,900+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11433145/

The cost-effectiveness of preventing, diagnosing, and treating ... We undertook a systematic review to identify, assess, and synthesise cost-effectiveness evidence on postpartum interventions to prevent, diagnose, or treat PPH.

2. augusta.edu augusta.edu/mcg/center-for-digital-health/bridging-the-gap-conference/documents/innovationearleydetection.pdf

Technology Solutions for Early Detection of Hemorrhage in ... Shock index: an effective predictor of outcome in postpartum haemorrhage? BJOG: An International Journal of Obstetrics & Gynaecology 122 ...

3. who.int who.int/news/item/09-05-2023-lifesaving-solution-dramatically-reduces-severe-bleeding-after-childbirth

Lifesaving solution dramatically reduces severe bleeding ... Severe bleeding – when a woman loses more than a litre of blood after birth - was reduced by 60%, and they were less likely to lose their life.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301211516308429

Outcomes of pelvic arterial embolization in the ... Caesarean section was performed in 62.1% of patients undergoing PAE for PPH. PAE was successful in 89.6% [95% confidence interval (CI) 78.3–100] of cases.

5. aha.org aha.org/guidesreports/2025-07-24-strategies-improving-postpartum-hemorrhage-outcomes

Strategies for Improving Postpartum Hemorrhage Outcomes Reduce Risk of Postpartum Hemorrhage​​ With improved data reporting and advanced data analysis tools, predictive analytics models can help more ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06655207

Study Details | NCT06655207 | Pivotal, Prospective, Multi- ... 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 ...

7. baymatob.com baymatob.com/index.php/clinical-product-information

Clinical & Product Information Oli PPH is the only product to have ever demonstrated the ability to identify women who are at higher risk of developing postpartum hemorrhage well before they ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7571554/

Implementation of a Postpartum Hemorrhage Safety ... Examination of maternal outcomes at Grady found that PPH complicated 11% of deliveries and was responsible for 7.5% of preventable pregnancy-related deaths in a ...

9. youtube.com youtube.com/watch?v=0nHIl7NvPP8

What is severe postpartum hemorrhage (PPH)? Definition ... Each year, around 14 million women experience postpartum hemorrhage, resulting in approximately 70,000 maternal deaths globally.

10. sciencedirect.com sciencedirect.com/science/article/pii/S0147651322009186

Association of maternal perfluoroalkyl substance exposure ... Our study suggested that maternal serum PFAS exposure during pregnancy was associated with the risk of postpartum haemorrhage.