Study population
For this study, we used data from 2 ongoing prospective cohorts among
pregnant women in The Netherlands. The PRegnancy and Infant DEvelopment
(PRIDE) Study aims to identify factors that affect maternal and child
health during or after pregnancy.14,15 The Dutch
Pregnancy Drug Register is a national registry for medication use during
pregnancy and lactation at the Netherlands Pharmacovigilance Centre
Lareb aiming to provide information on the safety of medication use and
modelled after the PRIDE Study.16 For both cohorts,
women aged ≥18 years were invited for participation as early in
pregnancy as possible by participating midwives and gynaecologists, as
well as through the ‘Moeders voor Moeders’ initiative and online
advertisements in the PRIDE Study. In the Netherlands, the data
collection for the International Registry of Antiepileptic Drugs and
Pregnancy EURAP17 is embedded in The Dutch Pregnancy
Drug Register, so women with epilepsy were oversampled. In both cohorts,
participating women were asked to complete Web-based questionnaires at
baseline, in gestational weeks 17 and 34, and at multiple time points
postpartum, starting 2 months after the estimated date of delivery.
Through these questionnaires, we gathered data on demographic
characteristics, obstetric history, maternal health including medication
use, lifestyle factors, pregnancy complications, and infant health.
Furthermore, PRIDE Study participants were asked consent for obtaining
records from prenatal care providers. The Regional Committee on Research
Involving Human Subjects approved the set-up of both cohorts. All
participants provided informed consent digitally.