title: Exploring the role of antithrombin replacement for the treatment of preeclampsia: a prospective randomized evaluation of the safety and efficacy of recombinant antithrombin in very preterm preeclampsia (PRESERVE-1).
abstract: OBJECTIVE
  Antithrombin (AT) replacement has been described in patients with hereditary AT deficiency undergoing delivery; however, the kinetics of AT replacement in preeclampsia is not adequately understood. Therefore, the Prospective Randomized Evaluation of the Safety and Efficacy of Recombinant Antithrombin in Very Preterm Preeclampsia (PRESERVE-1) study has been proposed.
  
  
  METHODS
  Sixty women aged≥18 years at 24 0/7-28 0/7 weeks' gestation and with hypertension and proteinuria will be enrolled and randomly assigned to receive recombinant human AT or placebo until fetal and/or maternal indications cause cessation of expectant management or until 34 0/7 weeks' gestation. The primary endpoint is the increase in gestational age from randomization to delivery. Safety assessments and laboratory assays will also be performed.
  
  
  RESULTS
  PRESERVE-1 study enrollment will begin during the second half of 2013.
  
  
  CONCLUSIONS
  The PRESERVE-1 study will provide further insight into the pharmacokinetic activity and safety of AT therapy in preeclampsia.
authors: Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine, New Haven, CT 06520-8063, USA. michael.paidas@yale.edu
authors: Michael J
authors: MJ
authors: Paidas
authors: Bahaeddine M
authors: BM
authors: Sibai
authors: Elizabeth W
authors: EW
authors: Triche
authors: Johan
authors: J
authors: Frieling
authors: Simon
authors: S
authors: Lowry
mesh_terms: D000293:Adolescent; D000328:Adult; D000465:Algorithms; D000991:Antithrombins / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D002985:Clinical Protocols; D005260:Female; D006801:Humans; D018579:Patient Selection; D011225:Pre-Eclampsia / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D011247:Pregnancy; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000627:therapeutic use; D012107:Research Design; D016896:Treatment Outcome; D014481:United States; D055815:Young Adult
chemical_list: D000991:Antithrombins; D011994:Recombinant Proteins