Background: Pregnancy is a vulnerable period when the foetus undergoes rapid development; therefore, exposure to adverse risk factors can have lifelong implications. Use of medicines during pregnancy is avoided where possible but is sometimes unavoidable. Whilst acute adverse effects following foetal exposure in utero have been assessed for several medicines, possible longer-term effects, specifically offspring neurodevelopmental delay and educational outcomes, are not well understood. Scotland and Wales are both world leading in having comprehensive countrywide health and education data which can be linked at an individual level enabling novel research to answer such questions.
Hypothesis: We hypothesise that some medications taken during pregnancy will be associated with poor child health, child neurodevelopmental and child educational outcomes.
Main aim: The overall research aim is to study pregnancy and long-term adverse outcomes in the offspring associated with antenatal exposure to medication. We aim to link pregnant mothers taking medication for specific conditions to a range of datasets to investigate the impact of antenatal drug exposure on obstetric and foetal outcomes, and longer-term health outcomes in the children.
Objectives: We specifically want to investigate the association between specific medications taken during pregnancy and
1. subsequent pregnancy outcomes
2. subsequent child health outcomes
3. subsequent child neurodevelopmental outcomes
4. subsequent child educational outcomes
Methods: The Scottish maternity database (SMR02) collects data on all births occurring in Scotland and includes maternal, obstetric and child factors and outcomes. Retrospective linkage to national prescribing data (2009-2019) will provide information on all prescribed medications dispensed to women immediately prior to, and during, their pregnancy (2010-2019) including dose and duration; whilst linkage to other health and education datasets will enable us to study a wide range of outcomes. We are specifically interested in pregnant women receiving medication to treat the following conditions: epilepsy, depression, ADHD, psychosis, asthma, diabetes (Type1, Type2 and gestational), hypertension, musculoskeletal pain, migraine, indigestion/heartburn/reflux, nausea/morning sickness, opiate drug withdrawal, and any infection necessitating prescription of antibiotics. Medications of interest therefore include: antiepileptics, antidepressants, antipsychotics, psychotropic agents, antihypertensives, antiasthma, methadone and buprenorphine, NSAIDs/paracetamol, antimigraine, H2 antagonists and proton pump inhibitors, anti-emetics, oral hypoglycaemics and insulin, and antibiotics. We will compare pregnancy, foetal and child outcomes for women receiving medications for specific conditions during the antenatal period compared to those who did not. We will utilise the SAIL Databank to replicate / validate our Scotland-wide research on pregnant women living in Wales using comparable population-wide Welsh data. The Welsh data will enable us to investigate the same outcomes described below and, in addition to national prescribing data, provides the added strength of national primary care data which is not available in Scotland. These data will enable us to additionally identify mother and child conditions recorded through GP records and will enable our comparison group of women not receiving the drugs of interest to be split further into those who have the underlying condition but are not medicated and those who do not have the underlying condition at all. Analysing these groups will enable us to differentiate between associations with the underlying condition and associations with the drugs used to treat them.
Expected outcomes: Demonstration of adverse associations or failure to demonstrate adverse associations would both be informative to clinicians and pregnant women in terms of caution or reassurance regarding use of the specific drug during pregnancy.
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