The WHO focuses on the lack of resources for premature birth and avoiding the use of drugs that are used off-label. Prematurity is the leading cause of neonatal mortality and is a major cause of complications and disability.

In Spain, according to the Spanish Society of Neonatology, 7% of babies are born before the 37th week of gestation. Since the withdrawal last year in the United States (US) of hydroxyprogesterone caproate ( Makena ) for spontaneous premature birth, there is no authorized medication in the country for this indication.