Women join landmark maternity medical device study

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Medical device company Baymatob says it has successfully completed one of Australia’s largest maternity health studies for a medical device, enrolling 500 mothers in a pilot study to evaluate its AI-guided labour monitoring device, Oli.

The device identifies women at higher risk of developing postpartum hemorrhage (PPH) well before they give birth.

The study was led by principal investigators Professor Michael Nicholls, Professor Andrew Bisits and Michelle de Vroom at two Sydney sites; Royal North Shore Hospital and The Royal Hospital for Women.

It used Baymatob’s wearable Oli to monitor the vital signs of both mother and child, with a focus on identifying mothers at high risk of PPH.

Postpartum hemorrhage, or heavy bleeding after childbirth, is the world’s leading cause of preventable maternal death. Globally, one mother dies every seven minutes due to postpartum hemorrhage.

The Oli device is an Australian-developed wearable device that combines sensor technology and artificial intelligence (AI) interpretation to detect a pending PPH during labour before birth and before postpartum bleeding starts.

Oli is worn on the upper abdomen of the mother both before and during labour and monitors physiological signals of mother and child, including biopotentials, movement, temperature, and deformation.

Lead investigator, midwife Michelle de Vroom, said a new detection method for PPH in Australia would dramatically improve patient outcomes for both mothers and children.

“PPH is responsible for nearly one-quarter of maternal deaths, and today’s approved monitoring technology – which focuses on contractions and heart rates – simply does not detect PPH and associated complications early enough. A large opportunity exists for modern technology, including artificial intelligence, wearable sensors and real-time analytics, to transform maternal and foetal monitoring and deliver better outcomes.

“While it is still early days in evaluating results, the data we have is very promising and indicates Oli’s effectiveness in identifying mothers at-risk of PPH before bleeding starts,” she said.

Baymatob CEO Tara Croft said the completion of its 500-patient pilot study puts the company on track to initiate a larger pivotal study at Australian and US sites.

"We’re so grateful to the 500 Australian mothers, obstetricians and midwifery staff who participated in this landmark study. The early results we have seen are already a strong indication of Oli’s potential impact and its potential for saving the lives of both mothers and children.

“Completing this Australian study paves the way for a larger pivotal trial in 2023, which will be critical in a successful FDA and TGA submission. Entering 2023, we are now readying to undertake this pivotal trial as we await final results of the pilot study,” she said.

The Oli device was originally developed by Sydney engineer and mother Dr Sarah McDonald, who established Baymatob after her own traumatic birth experience in 2013.