Nearly 9 in 10 women use medication during pregnancy. Most medications, however, lack robust data on fetal safety, in particular on long-term health outcomes in offspring. Most studies focus on immediate pregnancy outcome following exposure to medications in pregnancy. This lack of knowledge hampers evidence-based benefit-risk assessment of prescribing and using medications in clinical practice. As a result, women may refrain from pharmacological treatment indicated for severe maternal disorders such as asthma, hypertension, and mental illness, which may endanger maternal and child health if left untreated. Conversely, fetal development in other pregnancies may be disturbed by medications for which the risks have not yet been identified but could have been avoided. These issues emphasize the urgent need for more knowledge on the safety of medication use during pregnancy.
Because of ethical and medico-legal concerns regarding medication effects on the fetus, pregnant women are routinely excluded from randomized controlled trials (RCTs). In addition, outcomes that require long-term follow-up are generally not included or suitable for RCTs. Therefore, we must rely on observational studies to get more insight into the benefits and safety of medication use during pregnancy. Observational study designs come with methodological challenges, including the potential for confounding, selection bias, and misclassification of exposures, outcomes, and covariates, that may hamper causal inference. Some recent efforts to enhance observational studies using real-world data and prospective cohorts, such as genetically-informed research designs, implementation of the target trial framework, and application of machine learning algorithms, may generate more conclusive evidence on the long-term safety of prenatal medication exposure.
The objective of the current Research Topic is to provide a state-of-the art overview of clinical and epidemiologic studies on the long-term effects of medication use during pregnancy. We are specifically aiming at manuscripts describing Original Research or Reviews focusing on:
• The effects of prenatal exposure to medication and vaccines on child developmental, health, and social outcomes (traits and/or clinical diagnoses).
• Methodological developments to improve causal inference.
• Validation studies using real-world data on exposure, outcomes, or covariates.
• Etiologically relevant risk windows for adverse child health outcomes.
• Biological intermediates that may link prenatal medication exposure to long-term outcomes.
Nearly 9 in 10 women use medication during pregnancy. Most medications, however, lack robust data on fetal safety, in particular on long-term health outcomes in offspring. Most studies focus on immediate pregnancy outcome following exposure to medications in pregnancy. This lack of knowledge hampers evidence-based benefit-risk assessment of prescribing and using medications in clinical practice. As a result, women may refrain from pharmacological treatment indicated for severe maternal disorders such as asthma, hypertension, and mental illness, which may endanger maternal and child health if left untreated. Conversely, fetal development in other pregnancies may be disturbed by medications for which the risks have not yet been identified but could have been avoided. These issues emphasize the urgent need for more knowledge on the safety of medication use during pregnancy.
Because of ethical and medico-legal concerns regarding medication effects on the fetus, pregnant women are routinely excluded from randomized controlled trials (RCTs). In addition, outcomes that require long-term follow-up are generally not included or suitable for RCTs. Therefore, we must rely on observational studies to get more insight into the benefits and safety of medication use during pregnancy. Observational study designs come with methodological challenges, including the potential for confounding, selection bias, and misclassification of exposures, outcomes, and covariates, that may hamper causal inference. Some recent efforts to enhance observational studies using real-world data and prospective cohorts, such as genetically-informed research designs, implementation of the target trial framework, and application of machine learning algorithms, may generate more conclusive evidence on the long-term safety of prenatal medication exposure.
The objective of the current Research Topic is to provide a state-of-the art overview of clinical and epidemiologic studies on the long-term effects of medication use during pregnancy. We are specifically aiming at manuscripts describing Original Research or Reviews focusing on:
• The effects of prenatal exposure to medication and vaccines on child developmental, health, and social outcomes (traits and/or clinical diagnoses).
• Methodological developments to improve causal inference.
• Validation studies using real-world data on exposure, outcomes, or covariates.
• Etiologically relevant risk windows for adverse child health outcomes.
• Biological intermediates that may link prenatal medication exposure to long-term outcomes.