Direct-from-patient information on medication use:Protect pregnancy study results

Background: The PROTECT Pregnancy Study is a non-interventional, prospective study of pregnant women who provide information about medication use and key lifestyle factors at set intervals throughout their pregnancy, and pregnancy outcome. Objectives: This study was designed to pilot new methods of collecting pharmacovigilance data in natural language directly from reporters, whoever they are. Methods: Pregnant volunteers were sought mainly via the internet and leaflets in pharmacies. They were provided with study information and could choose to participate on-line or by phone using an interac... Mehr ...