Randomized, placebo controlled, double blind trial evaluating early pregnancy phytonutrient supplementation in the prevention of preeclampsia.

OBJECTIVE: Daily provision of pregnant patients with dietary supplements containing antioxidants and phytonutrients, if initiated in the first trimester of pregnancy and continued throughout the gestation, may significantly decrease the incidence of preeclampsia. STUDY DESIGN: We conducted a single center, randomized, placebo-controlled investigation in which women were randomized by their risk status and assigned to daily ingestion of a supplement consisting primarily of a blended fruit and vegetable juice powder concentrate or placebo. RESULT: Of the 684 patients randomized to the trial, 267 (39.0%) completed it. The final analysis is based on those participants who completed the study. For the primary outcome of preeclampsia, there was no difference observed between the phytonutrient supplement group and the placebo group: 15.9% vs 16.3%, respectively, (R.R. 0.97 (0.56-1.69)). Non-significant trends toward lower placenta-related obstetrical complications were observed in the supplement group compared with the placebo cohort (8.3% vs 15.5%, respectively, (R.R. 0.57 (0.29-1.14). Those infants born to mothers taking the supplement in the high-risk stratified group demonstrated non-significant trends toward lower rates of respiratory distress syndrome (RDS); 5.3% in the supplement group vs 15.4% in the placebo group: R.R. 0.34 (0.12-1.01). CONCLUSION: Initiation of antioxidant/phytonutrient supplementation in the first trimester did not decrease rates of preeclampsia. Non-significant trends toward lower incidences of placental derived morbidity in those mothers taking the supplement in addition to decreased rates of RDS in infants born to supplemented mothers considered to be high-risk for preeclampsia, warrant further investigation.

OS011. Management of late preterm pregnancy complicated by mildpreeclampsia: A prospective randomized trial.

INTRODUCTION: In the absence of properly undertaken prospective randomized clinical trials, the optimal management of late preterm mild preeclampsia for best maternal and perinatal outcomes remains unclear for obstetricians worldwide. OBJECTIVES: We desired to determine if immediate or expectant management of the late preterm mother presenting with mild preeclampsia was more beneficial to her without compromise to her newborn. METHODS: This prospective randomized clinical trial of immediate versus expectant delivery for patients presenting with mild preeclampsia between the late preterm period of 34-0/7 to 36-6/7weeks gestation was undertaken using CONSORT guidelines. Patients were randomized to immediate delivery via induction of labor or cesarean delivery or inpatient expectant management with delivery at 37-0/7weeks gestation or earlier at onset of labor or progression to severe preeclampsia. The primary outcome was progression to severe preeclampsia; secondary outcomes were neonatal morbidity and mortality. Data were analyzed by appropriate tests for continuous or categorical outcomes with differences considered significant if p<0.05. RESULTS: One hundred and sixty nine patients during 2002-2008 satisfied and sustained protocol criteria in the immediate delivery (n=94) or inpatient expectant management (n=75) arms of the study. A third (33%) of expectantly managed patients developed severe preeclampsia during significantly longer hospitalization versus 3% in the immediately delivered patients (p=0.001). Cesarean delivery rates were similar. No significant neonatal morbidity differences were observed between groups; there were no maternal or neonatal deaths. The study was stopped in 2008 at 74% of the enrollment target when hospital policy changed to discourage inpatient hospitalization for uncomplicated mild preterm preeclampsia and in view of growing national concern for increased late preterm/early term neonatal morbidity and cost of care. CONCLUSION: Proceeding to delivery of the late preterm (⩾34weeks gestation) patient with mild preeclampsia lessens maternal risk without significantly increasing neonatal risk.