Drug Exposure and Pregnancy Outcome in Mozambique

作者：Sevene Esperanca^*; Bardaji Azucena; Mariano Alda; Machevo Sonia; Ayala Edgar; Sigauque Betuel; Aponte John J; Carne Xavier; Alonso Pedro L; Menendez Clara

来源：Pediatric Drugs, 2012, 14(1): 43-49.

DOI：10.2165/11591270-000000000-00000

Background: The intake of medicines during pregnancy can have negative or toxic effects on the fetus, possibly leading to adverse pregnancy outcomes. %26lt;br%26gt;Objective: The aim of this study was to describe the level of drug exposure during pregnancy in a rural area of Mozambique and its relation to pregnancy outcome. %26lt;br%26gt;Methods: A total of 3105 pregnant women were interviewed in a cohort study. Information on disease, treatments received during pregnancy, and pregnancy outcome was collected. Newborns were examined at birth for clinical signs, birthweight, and presence of any congenital malformation. %26lt;br%26gt;Results: Malaria and sexually transmitted diseases were the most frequently reported diseases (30.5% and 24.1%, respectively), and 41% (1276/3105) of participants reported at least one drug exposure. The mean number of drugs taken per pregnant woman was 3.9 (SD 2.1). Antibiotics were the most commonly (41.2%) reported agents, followed by antimalarials (23.8%). There were more stillbirths (p %26lt; 0.007) among those reporting to be exposed to drugs compared with no exposure. Polydactyly was the most frequent malformation observed. %26lt;br%26gt;Conclusions: Drug exposure during pregnancy, including drugs with recognized potential pregnancy risk, was high in this rural area of southern Africa. The association of stillbirths with drug exposure might be a consequence of the disease that led to drug administration, although a direct causality of the drugs cannot be excluded. These findings emphasize the need for reinforcing pharmacovigilance systems in rural Africa, especially, or at least, in pregnant women.

• 出版日期2012