Safety of sildenafil citrate in the management of hypertensive disorders of pregnancy

Abstract

Objective This study investigated the safety of sildenafil citrate in managing hypertensive disorders of pregnancy. Patients and methods In a randomized, double-blind, placebo-controlled trial, 122 singleton pregnancies with mild pre-eclampsia between 28 and 36 weeks of gestation were randomized to either use oral sildenafil citrate tablets with antihypertensive or antihypertensive alone. The primary outcome was occurrence of maternal and/or neonatal complications. Results Headache was the most frequent adverse effect in the study and is significantly higher in the intervention group [22 (36.1%) vs. 12 (19.7%) in placebo group; P = 0.03]. In the intervention group, headache was dose related. The headache was tolerable in the majority of patients. The intervention group has an insignificant lower incidence of intrauterine growth restriction than the placebo group (1.7 vs. 6.7%, respectively, P = 0.31). The incidence of oligohydramnios was significantly higher in the placebo group than in the intervention group (16.7 vs. 8.5%, respectively, P = 0.03). No intrauterine fetal deaths have occurred in our study, and only one neonatal death occurred in the placebo group. Conclusion Using sildenafil citrate in addition to other antihypertensive drugs in the management of mild pre-eclampsia is safe and has a better maternal and neonatal outcome.