One in 400 pregnancies in Ireland and other developed countries ends in stillbirth, and in many cases stillbirths occur in babies with no apparent medical problems. What is known is that a baby’s movement pattern can change before a stillbirth; this prompted Niamh Nowlan, professor of biomedical engineering at UCD, to develop FeMo, a foetal monitoring device that allows expectant parents and clinicians to keep a much closer eye on a baby’s movements in the womb.
“My research is focused on three key areas: foetal movement monitoring, skeletal development and paediatric orthopaedics, and it was actually my interest in hip dysplasia that led to the foetal movement monitor,” says Prof Nowlan.
She wanted to find a way to correlate the kicks of a baby in the womb with the risk of hip dysplasia – a condition in which the hip joint does not properly form – after birth.
“However, there was no technology available to monitor movements in utero,” she says. “I quickly realised that being able to track and measure foetal movements from home with a wearable device would be a game-changer for pregnant people and their healthcare providers.”
Nowlan says FeMo operates a bit like a Fitbit for the unborn baby. “Currently pregnant people can feel their baby’s movements from the second trimester and are advised to ‘keep an eye’ on the baby’s movements and to come to hospital if they notice a change,” she says. “However, because there is no way to measure or monitor movements over long periods of time or from home, we don’t really know what a normal pattern is. Better monitoring technologies can provide the answers.”
Expectant parents get access to the FeMo app, which they use to check how their baby is moving. In addition, their clinical team will have full access to the data to inform their decision making. Nowlan says the app will provide reassurance for parents and also give them an understanding of what a normal movement pattern looks like. This will make it easier for them to judge if there has been a notable change.
“Collaboration has been central to the development of FeMo,” she says. “The device, which is currently being made in Ireland, has five separate parts, including the physical unit, the cloud and the firmware, so this calls for different engineering, technical and design expertise.”
The FeMo project is part of the Wellcome Leap In Utero programme, which aims to prevent stillbirths. To date, the device (the launch product from the company will trade under the name Maternitec) has received in the order of €2.7 million in research funding.
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In theory, FeMo could spin out of the university and become an OTC consumer product within a relatively short period of time. However, this is not an option Prof Nowlan is prepared to consider. For her, the device must stand up to rigorous scientific scrutiny and regulatory approval and make a real difference in people’s lives.
Robust clinical data is also critical to the acceptance of any new device by the medical community so the next step for the team (which includes Nowlan’s clinical co-investigator Prof Fionnuala McAuliffe of UCD and the National Maternity Hospital) is to prepare for a validation study of 1,000 pregnancies to chart the normal range of foetal movement over the last trimester. Once this is complete Nowlan will have clear scientific evidence to present to clinicians, the final design of the device can be signed off and the project can proceed to pilot stage.
Such studies are costly as the research parameters have to be carefully defined and overseen by a multidisciplinary team of scientists and clinical experts. Prof Nowlan estimates it will take around €4 million in funding to complete the study. FeMo is expected to spin out next year with the support of NovaUCD, the University’s research and innovation hub, and engagement with potential international investors to raise the research money is about to get under way.
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