The ConcePTION project aimed to establish a trusted research ecosystem to generate evidence on the safety of medicines during pregnancy and breastfeeding, using real-word data to help others make better-informed decisions about their healthcare.
The project developed a website called MUMS to provide pregnant and breastfeeding women with trusted information about medicine safety as well as an app called Meds4Mums2B, which not only provides women with access to trustworthy information but also enables users to report their own experience using medications while pregnant or breastfeeding, adding to the repository of real-world data on medicine safety during these periods of life.
Why are these resources needed?
Nine out of every ten pregnant or breastfeeding people in the EU take medicines, yet there is a huge gap in information available regarding medicine use during pregnancy and breastfeeding.
For many years, pregnant and breastfeeding women have been excluded from clinical trials. This was for a good reason – to ensure the baby would not come to any harm. But the knock-on effect of that is that for many medications, there is no strong body of evidence to say whether the drug is safe or not to take during pregnancy and breastfeeding. A staggering 71% of available medicines in the EU do not include information on whether or not it’s safe to use them while pregnant.
What there is, however, is real-world data. If you fall pregnant tomorrow and you have diabetes, or asthma, or epilepsy, you are not going to be the first woman to consider medicine use during your pregnancy. There is a wealth of real-world data in existence, but up until recently it was mostly scattered in different databases and it wasn’t harmonised, so insights couldn’t be gleaned from it.
Reliable information based on real-world data
Through the MUMS website and the Meds4Mums2B app, the ConcePTION project have made robust, evidence-backed medicine-use information freely available for pregnant and breastfeeding women to consult.
As well as providing reliable information on safe medicine use during pregnancy and breastfeeding, the app also collects information – women can report any side effects or experiences with a medicine while pregnant or breastfeeding by answering simple questions. These data will be analysed by the relevant health authority to further characterise the safety profiles of the medicine. In this way, the users of the app can share their own real-world experiences and this will help to inform future pregnant and breastfeeding women, and add to the body of knowledge regarding safe medicine use during pregnancy and breastfeeding.
MUMS contains freely available, up-to-date, accurate and unbiased information about the use of medicines in pregnancy, compiled from trusted sources and based on published scientific literature.
Using outputs from previous IMI projects
Before the app was developed, a survey of 450 people was carried out which emphasised the need for an easy‐to‐use, secure and reliable product.
Development was more efficient because it was based on another app produced as part of IMI’s WEB-RADR project. The WEB-RADR app allows patients to report side effects from different medicines directly, and to receive reliable information regarding medicine safety.
While the Med4Mums2B app has similar features, it is focused on medicine use during pregnancy and includes pregnancy-specific information; for instance, referring to the trimester that a person used medication etc. Using the proven design that was already developed by WEB-RADR meant that the app was already compatible with the tools that the pharmaceutical industry and the health authorities use.
Impact for pregnant and breastfeeding women
The MUMS knowledge bank and the Meds4Mums2B app represent a significant step forward in improving the safety and understanding of medicine use during pregnancy and breastfeeding. By combining trustworthy, evidence-based information with insights from reliable real-world data, these resources empower women to make informed healthcare decisions while contributing their own data to the wider medical community. Built on proven digital tools and supported by strong collaborations between research institutions, healthcare authorities, and the pharmaceutical industry, MUMS and Meds4Mums2B demonstrate how innovation and shared data can close long-standing knowledge gaps — ultimately ensuring safer treatment options for mothers and their babies.
ConcePTION is supported by the Innovative Medicines Initiative, a partnership between the European Union and the European pharmaceutical industry.
Accessibility
The MUMS knowledge bank is currently available in English, Polish and Italian, and links to other knowledge banks in Germany, France, Sweden and the Netherlands.
The Meds4Mums2B app was developed in partnership with the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and is currently available in the UK only.