Camgenium is Supporting Antenatal Care with MedTech App Reassure Pregnancy

Despite the immense advances in medical technology, women’s health remains underserved. In particular, there is a clear gap in technology to support expectant mothers during pregnancy. Technology has the potential to reduce serious complications by monitoring maternal health, but is not widely used.

Camgenium, specialists in medical software development, recognised an opportunity to utilise technology to provide support during pregnancy to people at risk of pre-eclampsia. If pre-eclampsia is left undiagnosed it can result in serious harm to pregnant mothers and their unborn children.

Camgenium developed the Reassure Pregnancy app and website, empowering individuals in high-risk pregnancies to proactively monitor their symptoms and record them in a simple app. The information recorded in the app is shared in real time to the clinic dashboard, enabling clinicians to remotely monitor people throughout high-risk pregnancies. Reassure Pregnancy is certified as a class I medical device because it provides alerts if it detects changes that indicate that the mother’s health may be deteriorating.

The Reassure Pregnancy app and website is currently in use at Milton Keynes University Hospital NHS Foundation Trust and University Hospitals Dorset – Poole. It was first introduced to Milton Keynes University Hospital in November 2018 and later to University Hospitals Dorset in April 2019.

The ability to remotely monitor the key indicators of pre-eclampsia gives pregnant people better control of their health. It also removes the burden of making multiple trips to the hospital. It frees up clinical time, often saving hundreds of pounds per pregnancy for the hospital. And, most importantly, for those individuals whose condition deteriorates, treatment and clinical supervision is provided faster, significantly improving outcomes for mothers and their babies. The Reassure app has been in daily use since its inception and has been used by over 1,000 women with high-risk pregnancies.

Pre-eclampsia is a key risk for pregnant women and their babies. The early signs of pre-eclampsia, as outlined by the NHS, include high blood pressure and protein in urine. These are typically monitored during a pregnant person' routine antenatal appointments by measuring blood pressure and testing urine for the presence of proteins using a ‘dipstick’ test.

Individuals who are deemed high risk need to be monitored more frequently which involves multiple trips to the maternity clinic to record blood pressure and urine protein. This can be logistically difficult for someone who cannot travel conveniently to the clinic or who has other small children. These appointments also take significant clinical time in already stretched maternity departments.

During the Covid pandemic regular trips to the hospital posed an even greater risk for pregnant women potentially exposing them to the virus.

Camgenium recognised that blood pressure measurements, urine protein tests and accompanying symptom monitoring could be safely undertaken at home, thus ensuring pregnant women didn’t need to make unnecessary trips to the hospital. They could simply monitor their own health and that of their unborn child each day at home.

Reassure Pregnancy is a medical device grade app and clinical website developed by Camgenium that enables pregnant women to monitor symptoms of pre-eclampsia and take control of their own health and that of their unborn child.

The app and the clinical website have been built on Camgenium’s flexible, no code, Xenplate software platform. This platform has prebuilt regulatory compliant modules. Camgenium is approved by the NHS to host websites on HSCN, the NHS private network. It is important to use HSCN for hosting the Reassure Pregnancy clinical website and clinician dashboard as it means that patient confidentiality is ensured by relying on existing NHS security systems. This eliminates the need for the burdensome level of secure access control that would be required were the system hosted on the internet. The patient apps connect to the clinical website via the internet, and Camgenium has NHS approved IT systems for linking applications on the internet to systems hosted on HSCN.

Medical device regulation applies to Reassure Pregnancy; it is a class I medical device because it provides alerts that patients and clinicians rely on to indicate that the mother and baby may be at risk. Camgenium is certified to ISO 13485, the international medical device standard, and is audited annually to this standard by BSI, the UK’s National Standards Body, and gold-standard auditor. Camgenium has developed Reassure Pregnancy to meet UKCA standards.