Neuroprotection with antepartum magnesium sulfate in preterm birth between 32 and 34 weeks' gestation: multicentre randomized clinical trial

Abstract

Background: Preterm birth is increasing each year. These children have more adverse outcomes due to the early birth, including neurodevelopmental outcomes. Cerebral palsy is one of that. Some studies have shown the protective effect of antepartum administration of magnesium sulphate in this event, but the high evidence is only in preterm labor before 32 weeks´ gestation. Objective: To prove the neuroprotective effect with the antepartum administration of magnesium sulphate in women with risk of spontaneous preterm labor between 32-34 completed WG, without secondary outcomes. Design and methods: It is a multicentre, randomized, double blind clinical trial involving 3524 women with spontaneous threat of preterm labor between 32 and 34 completed weeks´ gestation. These women will be randomized to be or not be treated with magnesium sulphate. It will be evaluated the presence of secondary outcomes in women and children in that moment and cerebral palsy in these children at two years. It will be executed in 7 Catalonia´s Hospitals