Surveillance of prescribed medicine in pregnancy

Lead Research Organisation: University College London
Department Name: Primary Care and Population Sciences

Abstract

A woman with a chronic disease often faces the dilemma on getting pregnant. Should she continue to take her medication or not? There is little evidence on whether prescribed medicines that benefit the mother may harm the unborn child. This is because pregnant women are often excluded from trials that test the medicine. Large clinical database with anonymised records from general practitioner provide unique opportunities to examine the prescribing in pregnancy and effects on mother and child.
My initial research focus on prescribing of antidepressants, antipsychotics and antibiotic prescribing during pregnancy. The results of this research will have important implications for both women of childbearing age and for health professionals providing antenatal care.

Technical Summary

Background: Women of reproductive age may benefit from new drugs that are well tolerated and with low side-effect profile, but these are often avoided in pregnancy. In circumstances where pregnant women have taken such drugs, there is a lingering uncertainty of the level of risk to the fetus even if the drugs enhance disease control in the mother. I will conduct a surveillance of prescribed medication in pregnancy and assess their harmful and beneficial effects. Initially, I will focus on prescription of antidepressants and Nicotine Replacement Therapy (NRT). Both of which are used to treat of conditions of major public health interests. These analyses will then inform similar work on anti-epileptics, antipsychotics, antibiotics and antihistamines.
Aims: To evaluate the prescription of medicines during pregnancy and assess the effects on the mother and child.
Objectives: 1) In women of childbearing age, to determine the influence of pregnancy on prescribing, and to examine factors associated with prescribing before and during pregnancy. 2) To determine the effect of prescribing, according to gestation of pregnancy, on postnatal outcomes in the mother and child
Design: Observational cohort study
Methodology: Cohorts of pregnant women and their children will be drawn from The Health Improvement Network (THIN) with data from 300 general practices across the UK comprising of more than 200,000 pregnancies and the data collection is ongoing. I will examine the prescription and changes during pregnancy and after birth compared to medication prescribed before pregnancy.
I will estimate absolute and relative risks of pregnancy and child outcomes using cohort design and explore methods such as the case-time-control approach to compare the potential harm or benefit of drug exposure at different stages in pregnancy. Multivariable and hierarchical regression models will be applied.
Scientific and Medical opportunities: These data will provide unparallel information on the existing practice of drug prescribing in pregnancy and the effects of these drugs on maternal and child health. This information will be used to inform current prescribing practice in women during pregnancy and will also identify areas for further research.

Publications

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