Efficacy of antioxidant bitherapy administration on the incidence of preeclampsia in pregnant women with obesity: a randomized, double-blind, placebo-controlled clinical trial

Abstract

BACKGROUND: Preeclampsia is a multifactorial hypertensive disorder of pregnancy, characterized by new-onset hypertension and proteinuria or other signs of organ or uteroplacental dysfunction, occurring after 20 weeks of gestation. Despite advancements in maternal care, preeclampsia is present in around 2-8% of the pregnancies and remains a leading cause of maternal and neonatal morbidity and mortality worldwide. Its pathophysiology includes systematic inflammation, endothelial dysfunction and increased oxidative stress. Pregnant women with obesity face a higher risk of developing preeclampsia due to compounded oxidative stress, ongoing inflammation, and metabolic imbalances related to obesity. Antioxidant treatments have been suggested as a potential approach to reduce oxidative harm and enhance pregnancy results, but not successful results have been shown. Therefore, this study proposes a combination of two antioxidants to create a synergic effect and reduce the incidence of preeclampsia in pregnant women with obesity, and consequently, all the complications that are associated. OBJECTIVES: The primary objective is to evaluate the efficacy of the antioxidant bitherapy (lycopene and selenium supplements) compared to placebo on decreasing the incidence of preeclampsia in pregnant women with obesity. Secondary objectives include assessing whether it delays the onset and decreases the severity of preeclampsia, if it reduces the incidence of intrauterine growth restriction, and if it lowers the rate of cesarean sections. DESIGN: This study is designed as a randomized, double-blinded, placebo-controlled, parallel-group prospective clinical trial at the Hospital Universitari Josep Trueta in Girona. PARTICIPANTS AND METHODS: A total of 310 patients will be recruited and divided into two groups: Intervention group will receive the antioxidant bitherapy (lycopene and selenium supplements) and the control group will receive placebo. Key study variables will be assessed during all the pregnancy in the routine prenatal care visits and in the delivery