title: Safety and efficacy of thromboprophylaxis using enoxaparin sodium after cesarean section: A multi-center study in Japan.
abstract: OBJECTIVE
  Pulmonary embolism (PE) is the leading cause of maternal death in developed countries, and the prevention of venous thromboembolism (VTE) is a pivotal part of current obstetric care. This study evaluated the safety and efficacy of enoxaparin sodium for thromboprophylaxis after cesarean section (C/S), and analyzed the risk factors associated with VTE.
  
  
  METHODS
  One hundred and forty-three women deemed to be at high risk of postoperative deep vein thrombosis (DVT) were enrolled between January 2011 and May 2012 in seven institutions in Japan. Subcutaneous administration of enoxaparin 4000 units/d was initiated 24-36 hours after C/S for 5 days. Adverse events, based on the Common Terminology Criteria for Adverse Events, Version 4, were recorded. The diagnoses of PE and DVT were made on clinical signs. Venous ultrasonography in the lower extremities was performed in 102 patients. The association between VTE and various risk factors was evaluated using univariate analysis.
  
  
  RESULTS
  There were 10 (7.0%) Grade 1 adverse events: elevated aspartate aminotransferase or alanine aminotransferase levels in eight patients, chest pain in one patient, and subcutaneous hematoma in one patient. No patients showed clinical signs of PE and/or DVT. Among 102 patients who underwent venous ultrasonography, thrombus was detected in unilateral soleus veins in four (3.9%) patients. A body mass index (BMI) ≥ 25 kg/m(2) before pregnancy was associated with asymptomatic DVT.
  
  
  CONCLUSIONS
  The current study demonstrates the safety and efficacy of enoxaparin for thromboprophylaxis after C/S. Further studies are required to determine the best method of preventing asymptomatic DVT.
authors.affiliation: Department of Obstetrics and Gynecology, Iizuka Hospital, Iizuka, Japan.
authors.forename: Maki
authors.initials: M
authors.lastname: Goto
authors.affiliation: Center for Maternal, Fetal, and Neonatal Medicine, Fukuoka University Hospital, Fukuoka, Japan. Electronic address: ty-obgyn@cis.fukuoka-u.ac.jp.
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Yoshizato
authors.affiliation: Department of Obstetrics and Gynecology, Yamaguchi Red Cross Hospital, Yamaguchi, Japan.
authors.forename: Masato
authors.initials: M
authors.lastname: Tatsumura
authors.affiliation: Department of Obstetrics and Gynecology, Kitakyushu Municipal Hospital, Fukuoka, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Takashima
authors.affiliation: Department of Obstetrics and Gynecology, Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.
authors.forename: Masanobu
authors.initials: M
authors.lastname: Ogawa
authors.affiliation: Department of Obstetrics and Gynecology, Japan Community Health Care Organization Kyushu Hospital, Fukuoka, Japan.
authors.forename: Hiromasa
authors.initials: H
authors.lastname: Nakahara
authors.affiliation: Department of Obstetrics and Gynecology, Oita Prefectural Hospital, Oita, Japan.
authors.forename: Shoji
authors.initials: S
authors.lastname: Satoh
authors.affiliation: Department of Obstetrics and Gynecology, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.
authors.forename: Ayako
authors.initials: A
authors.lastname: Sanui
authors.affiliation: Department of Obstetrics and Gynecology, Iizuka Hospital, Iizuka, Japan.
authors.forename: Fuyuki
authors.initials: F
authors.lastname: Eguchi
authors.affiliation: Center for Maternal, Fetal, and Neonatal Medicine, Fukuoka University Hospital, Fukuoka, Japan; Department of Obstetrics and Gynecology, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.
authors.forename: Shingo
authors.initials: S
authors.lastname: Miyamoto
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D001219:Aspartate Aminotransferases / Q000097:blood; D058070:Asymptomatic Diseases; D015992:Body Mass Index; D002585:Cesarean Section; D017984:Enoxaparin / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007564:Japan; D035002:Lower Extremity / Q000000981:diagnostic imaging; D008875:Middle Aged; D011655:Pulmonary Embolism / Q000517:prevention & control*; D012307:Risk Factors; D014463:Ultrasonography; D054556:Venous Thromboembolism / Q000000981:diagnostic imaging / Q000517:prevention & control*; D020246:Venous Thrombosis / Q000000981:diagnostic imaging / Q000517:prevention & control*; D055815:Young Adult
chemical_list: D000925:Anticoagulants; D017984:Enoxaparin; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase
keywords: cesarean section; low-molecular-weight heparin; venous thromboembolism; venous ultrasonography