title: Perinatal and Hemodynamic Evaluation of Sildenafil Citrate for Preeclampsia Treatment: A Randomized Controlled Trial.
abstract: To evaluate whether therapy with sildenafil citrate prolongs gestation in women with preeclampsia.
  
  
  
  In a randomized double-blind, placebo-controlled trial, 100 singleton pregnancies with preeclampsia between 24 and 33 weeks of gestation were randomized to 50 mg oral sildenafil citrate every 8 hours or placebo. The primary outcome was prolongation of pregnancy from randomization to delivery. Secondary outcomes were changes in resistance indices of uterine, umbilical, and middle cerebral arteries by Doppler, fetal and maternal complications, and adverse neonatal outcomes. Power analysis estimated that to detect a difference of 5 days in pregnancy duration, 43 patients would have to be randomized to each group.
  
  
  
  From June 2013 to October 2015, 50 patients were randomized to each group. Pregnancy duration was on average 4 days longer (14.4 days, 95% confidence interval [CI] 12.5-16.6 days compared with 10.4 days, 95% CI 8.4-12.3 days, P=.008) and percent reduction in pulsatility indices of uterine and umbilical arteries higher (22.5% and 18.5%, compared with placebo 2.1% and 2.5%, P<.001) for patients treated with sildenafil compared with placebo. Maternal blood pressure before and 24 hours after randomization was lower with sildenafil (sildenafil: 100.3±5.6 mm Hg compared with 116.4±5.1 mm Hg, P<.05; placebo: 110.6±6.2 mm Hg compared with 114.7±6.5 mm Hg, P=.21). There was no difference in perinatal morbidity, mortality, or adverse effects between groups.
  
  
  
  Therapy with sildenafil citrate was associated with pregnancy prolongation of approximately 4 days compared with placebo in women with preeclampsia.
  
  
  
  Brazilian Registry of Clinical Trials, www.ensaiosclinicos.gov.br, RBR-8qj4p5.
authors.affiliation: Hospital of Federal University of Santa Catarina and the Postgraduate Program in Medical Sciences, Federal University of Santa Catarina, Florianopolis, and the University of Southern Santa Catarina, Medical School, Palhoça, SC, Brazil; and the Departments of Obstetrics and Gynecology and Radiology, Oakland University William Beaumont School of Medicine, Rochester, Michigan.
authors.forename: Alberto
authors.initials: A
authors.lastname: Trapani
authors.forename: Luis Flavio
authors.initials: LF
authors.lastname: Gonçalves
authors.forename: Thamyris Finger
authors.initials: TF
authors.lastname: Trapani
authors.forename: Simone
authors.initials: S
authors.lastname: Vieira
authors.forename: Marilen
authors.initials: M
authors.lastname: Pires
authors.forename: Maria Marlene de Souza
authors.initials: MMS
authors.lastname: Pires
mesh_terms: D000328:Adult; D001783:Blood Flow Velocity / Q000187:drug effects; D001794:Blood Pressure / Q000187:drug effects; D004311:Double-Blind Method; D005260:Female; D005865:Gestational Age; D006801:Humans; D020768:Middle Cerebral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D058986:Phosphodiesterase 5 Inhibitors / Q000494:pharmacology / Q000627:therapeutic use*; D011225:Pre-Eclampsia / Q000188:drug therapy* / Q000503:physiopathology*; D011247:Pregnancy; D011255:Pregnancy Maintenance / Q000187:drug effects; D000068677:Sildenafil Citrate / Q000494:pharmacology / Q000627:therapeutic use*; D013997:Time Factors; D018608:Ultrasonography, Doppler; D014469:Umbilical Arteries / Q000000981:diagnostic imaging / Q000503:physiopathology; D055988:Uterine Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D014655:Vascular Resistance / Q000187:drug effects; D055815:Young Adult
chemical_list: D058986:Phosphodiesterase 5 Inhibitors; D000068677:Sildenafil Citrate