ABSTRACT OF THE THESIS submitted by Ezereth Susan Kabuluzi for the degree of Doctor of Philosophy entitled 'Assessment of Risk of Drug Exposure in Early Pregnancy in Women in a Rural Community in Malawi'April 2012Introduction: Medication use by women of childbearing age is common. During pregnancy, medications should be used cautiously because some are teratogenic and/or feto-toxic, especially during the first trimester. Few studies have assessed exposure to contraindicated medications in developing countries.Aims and objectives: The overall aim was to assess the risk of exposure to contra-indicated medicines in early pregnancy (less than 13 weeks gestation) in Malawi. Specific objectives were to (i) determine the proportion of women inadvertently prescribed contraindicated medicines in the first trimester of pregnancy in a general outpatient clinic; (ii) explore women's beliefs, views and practices concerning medication use during pregnancy; (iii) determine the prevalence of congenital abnormalities by review of records at community and central hospital sites; (iv) to make appropriate recommendations for policy and practice in Malawi relating to medication use in pregnancy.Methods: A mixed methods approach was used. Survey data were collected at an outpatient clinic at Mitundu Community Hospital (MCH) between 1st February 2010 and 30th July 2010 to determine the range of medicines taken by potentially pregnant women. A pregnancy test established the pregnancy rate in this group. These data were summarised using descriptive and inferential statistics, and the proportions of exposed women who were pregnant were estimated. To understand women's beliefs, views and practices, semi-structured interviews were held with 21 pregnant women at their first visit to an antenatal clinic at MCH. The main themes were identified by Framework analysis. Retrospective data were abstracted from birth registers at MCH and Kamuzu Central Hospital (KCH) to estimate the prevalence of congenital abnormalities. Results: Of 1103 women prescribed contraindicated medicines in the outpatient clinic, 272 were potentially pregnant. Of the 63 (23.2%) confirmed pregnant (95% CI 18.3%-28.6%), 20 knew or thought they were pregnant, 22 were not sure and 21 did not think they were pregnant. Only 153 (55.9%) were asked about pregnancy by a medical officer before prescription. 3.2% of all pregnant women (95% CI 2.5%-4.1%) attending the clinic were estimated to have been prescribed contraindicated medicines. Eight pregnant women also self-prescribed unsuitable modern medications. Women accepted as safe any medications prescribed in the clinic. They also accepted potions given by traditional birth attendants to counter witchcraft, which they believed caused pregnancy loss. They did not associate use of these medicines with congenital abnormalities, the prevalence of which (6.58/1000 births at MCH, 14.55/1000 births at KCH) was similar to international figures.Conclusion: The study highlights areas of concern for practice, policy and research relevant to maternal health care in Malawi. Clinicians need to reduce the rate of exposure to potentially harmful medicines by paying attention to the possibility of pregnancy in women of childbearing age. There is also a need to facilitate public awareness especially among women about dangers of taking medicines.