Predictive maternal and fetal monitoring device Oli completes recruitment of 1,000 mothers for pivotal clinical trial
Oli, a wireless wearable device that monitors maternal and fetal signals, has completed patient recruitment for its fourth and final clinical trial prior to TGA and FDA submission, successfully enrolling 1,000 mothers across seven hospital sites in Australia and the United States.
This marks a significant milestone ahead of regulatory submissions as Oli progresses toward commercial launch. The trial is evaluating Oli’s first clinical application, postpartum haemorrhage (PPH), one of the leading causes of maternal death globally.
Recruitment of this scale and speed is highly uncommon in women’s health research, where most device-based maternal studies typically involve significantly smaller cohorts. Oli reached full enrolment of 1,000 mothers in approximately six months, a pace unheard of in clinical research, reflecting both strong clinician support and positive patient acceptance of the technology. Clinicians have adopted Oli into existing maternity workflows with ease, while mothers have responded positively to Oli’s design, which enables comfortable monitoring without interruption or restriction of movement, supporting a wider range of birthing environments including time in water.
"Clinical trials are ultimately about patients. Every woman who has chosen to participate in this pivotal study is helping shape the future of maternal care and we're incredibly grateful for the trust they've placed in us. The commitment and dedication from all our sites to recruit so quickly shows us how clinician- and patient-friendly Oli truly is," said Bernadette Pickering, Director of Clinical Operations at Oli.
"Women deserve access to the safest and most advanced healthcare available. This clinical trial brings us one step closer to changing how maternal and fetal healthcare is delivered globally. We’re deeply grateful to every clinician, researcher and family involved," said Sue Nettleton, Clinical Development Lead at Oli.
Results from the pivotal clinical trial are expected in the coming months. Participating hospitals include: Columbia University Irving Medical Center (New York City, New York State), University of Pittsburgh Medical Center – UPMC Magee-Women’s Hospital (Pittsburgh, Pennsylvania), The Ohio State University Wexner Medical Center (Columbus, Ohio), University of Colorado Anschutz Medical Campus (Denver, Colorado), Woman’s Hospital (Baton Rouge, Louisiana), Royal North Shore Hospital (Sydney, Australia) and The Royal Hospital for Women (Sydney, Australia).
Oli’s technology captures maternal and fetal physiological data across 10 biosensors simultaneously, translating this information through its patented Predictive Maternal-Fetal Signal technology into live clinical signals designed to identify risk earlier and support proactive intervention to improve health outcomes. Oli aims to analyse up to 15 maternal and fetal conditions and complications across pregnancy and birth, including postpartum haemorrhage (PPH), fetal distress, stillbirth risk and labour progression.
“Pregnancy and birth are some of life’s most significant and transformative moments, and we’re working toward a future where they truly belong to the people in the room. We’re focused not only on improving health outcomes through earlier predictive insight, but also on changing the experience of birth itself. One where clinicians can trust the signal in the room and focus fully on the mother in front of them, and where mothers can focus on birthing their baby calmly and confidently, without interruption. The 1,000-patient recruitment milestone is a significant achievement, and we’re excited for what comes next,” said Tara Croft, CEO at Oli.