Expectant management of severe preeclampsia remote from term: The MEXPRE Latin Study, a randomized, multicenter clinical trial

摘要

Objective The objective of the study was to determine whether expectant management of severe preeclampsia prior to 34 weeks of gestation results in improved neonatal outcome in countries with limited resources. Study Design This was a randomized clinical trial performed in 8 tertiary hospitals in Latin America. Criteria of randomization included gestational age between 28 and 33 weeks' gestation and the presence of severe hypertensive disorders. Patients were randomized to steroids with prompt delivery (PD group) after 48 hours vs steroids and expectant management (EXM group). The primary outcome was perinatal mortality. Results A total of 267 patients were randomized, 133 to the PD group and 134 to the EXM group. Pregnancy prolongation was 2.2 days for the PD group vs 10.3 days for the EXM group (P =.0001). The rate of perinatal mortality (9.4% vs 8.7%; P =.81; relative risk [RR], 0.91; 95% confidence interval [CI], 0.34-1.93) was not improved with expectant management, and neither was the composite of neonatal morbidities (56.4% vs 55.6%; P =.89; RR, 01.01; 95% CI, 0.81-1.26). There was no significant difference in maternal morbidity in the EXM group compared with the PD group (25.2% vs 20.3%; P =.34; RR, 1.24; 95% CI, 0.79-1.94). However, small gestational age (21.7% vs 9.4%; P =.005; RR, 2.27; 95% CI, 1.21-4.14) and abruption were more common with expectant management (RR, 5.07; 95% CI, 1.13-22.7; P =.01). There were no maternal deaths. Conclusion This study does not demonstrate neonatal benefit with expectant management of severe preeclampsia from 28 to 34 weeks. Additionally, a conservative approach may increase the risk of abruption and small for gestational age.