Core data elements for pregnancy pharmacovigilance studies using primary source data collection methods: Recommendations from the IMI ConcePTION project
JL Richardson, A Moore, RL Bromley, M Stellfeld… - Drug Safety, 2023 - Springer
Abstract Introduction and Objective The risks and benefits of medication use in pregnancy
are typically established through post-marketing observational studies. As there is currently …
are typically established through post-marketing observational studies. As there is currently …
A comparison of infants' birth defects self‐reported by mothers with data provided by general practitioners: Data from the Dutch Pregnancy Drug Register
VYF Maas, EGT Ederveen… - Birth Defects …, 2024 - Wiley Online Library
Background Since the presence of a birth defect is often a primary outcome in drug‐safety
studies among pregnant women, researching the validity of data collection methods is …
studies among pregnant women, researching the validity of data collection methods is …
Social media monitoring on the perceived safety of medication use during pregnancy: A case study from the Netherlands
MMHJ van Gelder, A Rog, SJH Bredie… - British journal of …, 2019 - Wiley Online Library
Aims An increasing number of women trust the Internet for information about medication
safety during pregnancy. This study aimed to evaluate the availability and accuracy of social …
safety during pregnancy. This study aimed to evaluate the availability and accuracy of social …
Maternal first trimester COVID‐19 vaccination and risk of major non‐genetic congenital anomalies
PJ Woestenberg, M de Feijter… - Birth Defects …, 2023 - Wiley Online Library
Background Information regarding the risk of early pregnancy COVID‐19 vaccination on the
development of major congenital anomalies in the offspring is still limited. Here, we study the …
development of major congenital anomalies in the offspring is still limited. Here, we study the …
Experiences and perspectives of marketing authorisation holders towards medication safety monitoring during pregnancy: A pan-European qualitative analysis
L Sillis, V Foulon, JY Verbakel… - International Journal of …, 2022 - mdpi.com
Although marketing authorisation holders (MAHs) are involved in monitoring medication
safety, it was unclear how they experience their role and current monitoring activities in …
safety, it was unclear how they experience their role and current monitoring activities in …
Dutch trends in the use of potentially harmful medication during pregnancy
E Houben, B Te Winkel, EAP Steegers… - British journal of …, 2020 - Wiley Online Library
Aims Recent population‐based data on drug utilization around pregnancy are lacking. This
study aims to examine the prevalence of drug exposure in the Netherlands during the …
study aims to examine the prevalence of drug exposure in the Netherlands during the …
Information needs and counseling preferences among potential users of the future Teratology information service in Belgium: A cross-sectional study involving the …
M Ceulemans, K Van Calsteren, K Allegaert… - International Journal of …, 2022 - mdpi.com
A Teratology Information Service (TIS) does not exist in Belgium yet but will hopefully be
established soon. To prepare for this, we aimed to provide insight into the information needs …
established soon. To prepare for this, we aimed to provide insight into the information needs …
Development and design of the BELpREG registration system for the collection of real-world data on medication use in pregnancy and mother-infant outcomes
Although medication use during pregnancy is common, most available products lack
sufficient safety information. As prospective data collection and perinatal …
sufficient safety information. As prospective data collection and perinatal …
Elements to assess the quality of information of case reports in pregnancy pharmacovigilance data—a ConcePTION project
YRJ van Rijt-Weetink, K Chamani… - Frontiers in Drug …, 2023 - frontiersin.org
To assess the risk of exposure to a medicinal product during pregnancy in an individual
case report, the necessary information should be present, complete and clearly described …
case report, the necessary information should be present, complete and clearly described …
Associations between late-onset preeclampsia and the use of calcium-based antacids and proton pump inhibitors during pregnancy: a prospective cohort study
MMHJ van Gelder, P Beekers… - Clinical …, 2022 - Taylor & Francis
Purpose Preeclampsia is a leading cause of maternal morbidity and mortality. Calcium-
based antacids and proton pump inhibitors (PPIs) are commonly used during pregnancy to …
based antacids and proton pump inhibitors (PPIs) are commonly used during pregnancy to …