OBJECTIVES: Clinical trials have well-known limitations to study drug safety in vulnerable populations, including pregnant women and their offspring. Real-world data and related observational population-based research have the potential to fill this gap as a non-invasive method for studies in these groups. It was explored whether linkage of the PHARMO Data Network (PHARMO) and the Netherlands Perinatal Registry (Perined) would establish a valuable data source for perinatal pharmacoepidemiological studies in the Dutch population.

METHODS: A new infrastructure was established based on the record linkage of PHARMO and Perined: the PHARMO Perinatal Research Network (PPRN). PHARMO represents a population-based data source with combined anonymous electronic healthcare data from different healthcare settings in the Netherlands. Perined is a nationwide registry containing maternal and neonatal characteristics and data on perinatal care. Pregnancies between 2000 and 2021 of women registered in Perined as well as PHARMO were included. Mother-child linkage in PHARMO was also assessed.

RESULTS: The PPRN included 744,675 pregnancies of 491,672 women (mean (±SD) age at delivery 31.2 (±4.8) years). Additionally, mother-child linkage was available for about one fifth of these pregnancies. The PPRN contains preconceptional information on maternal healthcare, as well as detailed pregnancy and neonatal data, extending into long-term follow-up after birth for both mother and child up to more than 20 years. It includes linked data from different primary and secondary healthcare settings, such as pharmacies, general practitioners, and hospitals, with ongoing annual updates of the routinely collected data.

CONCLUSIONS: The PPRN provides a unique and rich data set facilitating in depth large-scale observational perinatal research. The patient-level linkage of many different healthcare data sources allows assessment of patient journeys of both mother and child during the preconception period, pregnancy, and after birth.