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Maternal prescriptive drug use: the risks and benefits to mothers and neonates

Safe People

Organisation name

University of Bristol

Organisation sector

Academic Institute

Applicant name(s)

Neil Davies - Chief Investigator - University of BristolCiarrah-Jane Barry - Corresponding Applicant - University of BristolDheeraj Rai - Collaborator - University of BristolFlorence Martin - Collaborator - University of BristolGemma Sharp - Collaborator - University of BristolHarriet Forbes - Collaborator - University of BristolKayleigh Easey - Collaborator - University of BristolPaul Madley-Dowd - Collaborator - University of BristolVenexia Walker - Collaborator - University of Bristol

Safe Projects

Project ID

CPRD34

Lay summary

Prescribing medication provides a challenge for physicians when considering a pregnant patient. Here the beneficial effect of the drug must be balanced against possible adverse effects on the mother and unborn child. For many drugs prescribed throughout pregnancy, there is very little definitive evidence of safety as pregnant women are rarely recruited to clinical trials for ethical and practical reasons. This presents a significant problem as there are a range of chronic conditions requiring ongoing treatment, such as depression, diabetes, hypertension, and thyroid conditions that may precede or develop during the pregnancy. This use necessitates a method to safely and accurately discern whether there are adverse offspring outcomes associated with these treatments, alongside evaluating the extent of the maternal benefit. Electronic healthcare databases are a source of routinely collected, anonymised healthcare data which can be used to investigate associations between intrauterine drug exposure and maternal and neonatal outcomes, whilst avoiding the possible dangers of implementing randomised control trials. Thus, we aim to use available observational data to investigate potential risks currently associated with prescriptive drugs under circumstances where we are unable to perform a randomised controlled trial. To establish this evidence, we will investigate the relationship between maternal drug prescriptions and adverse and beneficial offspring outcomes to provide evidence to guide clinical decisions.

Technical summary

It is increasingly common for pregnant women to be prescribed medication for chronic conditions. Depression and antidepressant use are increasingly common in women of a child-bearing age, with studies suggesting that up to 20% of pregnant women suffer from depression during pregnancy [1]. In addition, cardiovascular related conditions are relatively common, with 15% of pregnant women experiencing hypertension. Although less common, endocrine conditions, such as diabetes and thyroid disorders, are persistent and problematic within pregnancy, affecting around 4% and 10% of pregnant women respectively [2, 3].

Latest approval date

13/05/2021

Safe Data

Dataset(s) name

CPRD Mother-Baby Link

HES Admitted Patient Care

Mental Health Services Data Set (MHSDS)

ONS Death Registration Data

Practice Level Index of Multiple Deprivation

Safe Setting

Access type

Release