Planned Delivery or Expectant Management for Late Preterm Pre-Eclampsia in Low-Income and Middle-Income Countries (CRADLE-4): A Multicenter, Open-Label, Randomized Controlled Trial

Abstract

(Lancet. 2023;402:386–396) Pre-eclampsia is a relatively common condition and poses a disproportionately high risk to women in low-income and middle-income countries where it is a leading cause of maternal morbidity and mortality, estimated to have caused more than 42,000 deaths. The only known treatment is delivery, but there are also risks associated with preterm delivery that can contribute to both maternal and neonatal outcomes. Evidence suggests delivery at 37 weeks optimizes outcomes for both mother and infant, but there is little evidence about delivery in the late preterm gestational period leading up to that, between 34 and 36 and 6/7 weeks. Research in higher income settings has shown that fetal death in these cases is rare, but there are factors in such settings that are unavailable or unrealistic in low-income and middle-income settings. This study aimed to address the gap in knowledge by assessing outcomes related to planned delivery between 34 and 37 weeks in women with pre-eclampsia compared with expectant management during the same gestational period in India and Zambia.