POMME: The New Cohort to Evaluate Long-Term Effects After Prenatal Medicine Exposure.

Abstract

The POMME (PrescriptiOn Médicaments Mères Enfants) cohort has been implemented for the evaluation of the long-term consequences of medicine prenatal exposure. It holds anonymous medical information as well as information on medicine and healthcare reimbursement to the children, from the first day of intra-uterine life until childhood. This article provides a description of the cohort regarding its structure and content and presents an outlook of the studies that could be performed with this new data source. Data sources include (1) the French Health Insurance Database (medicines and medical care prescriptions and reimbursements to children and mothers during pregnancy) and (2) the Mother and Child Protection Centre Database (child health certificates at birth, 9months of age and 24months of age). Children born in Haute-Garonne (south-west France), over a period of 1year (from 1 July to 30 June), are registered in POMME every 5years. The cohort began on 1 July, 2010. To date, 8372 children have been recorded in POMME. They have reached 7years of age now. Among them, 4249 (50.8%) are boys, 286 (3.4%) were from multiple pregnancies and 519 (6.2%) were born prematurely. They were prenatally exposed to 9.8 ± 6.1 medications. After birth, drug exposure was greatest in children aged 0-2years. Children were mostly exposed to paracetamol, anti-infective agents and respiratory system drugs; 908 (10.8%) children presented with at least two signs of psychomotor development disorders. POMME provides an observatory study on drug exposure and medical care use in children. This innovative cohort would make it possible to assess the risk of the long-term consequences of prenatal medicine exposure.