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). (27th February 2013)

• Record Type: Journal Article
• Authors: Paidas, Michael J.; Sibai, Bahaeddine M.; Triche, Elizabeth W.; Frieling, Johan; Lowry, Simon
• Is Part Of: American journal of reproductive immunology. Volume 69:Number 6(2013:Jun.)
• Page Start: 539
• Page End: 544
• Publication Date: 2013-02-27
• Subjects: Human reproduction -- Immunological aspects -- Periodicals; 616.69206
• DOI: 10.1111/aji.12091
• Languages: English
• ISSNs: 1046-7408

Abstract

<abstract abstract-type="main" xml:lang="en" id="aji12091-abs-0001"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="aji12091-sec-0001" sec-type="section"> <title>Problem</title> <p>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.</p> </sec> <sec id="aji12091-sec-0002" sec-type="section"> <title>Methods</title> <p>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.</p> </sec> <sec id="aji12091-sec-0003" sec-type="section"> <title>Results</title> <p>PRESERVE‐1 study enrollment will begin during the second half of 2013.</p> </sec> <sec id="aji12091-sec-0004" sec-type="section"> <title>Conclusion</title> <p>The PRESERVE‐1 study will provide further insight into the pharmacokinetic activity and safety of AT therapy in preeclampsia.</p> </sec> </abstract>