Maki Goto1, Toshiyuki Yoshizato2, Masato Tatsumura3, Takeshi Takashima4, Masanobu Ogawa5, Hiromasa Nakahara6, Shoji Satoh7, Ayako Sanui8, Fuyuki Eguchi1, Shingo Miyamoto9. 1. Department of Obstetrics and Gynecology, Iizuka Hospital, Iizuka, Japan. 2. Center for Maternal, Fetal, and Neonatal Medicine, Fukuoka University Hospital, Fukuoka, Japan. Electronic address: ty-obgyn@cis.fukuoka-u.ac.jp. 3. Department of Obstetrics and Gynecology, Yamaguchi Red Cross Hospital, Yamaguchi, Japan. 4. Department of Obstetrics and Gynecology, Kitakyushu Municipal Hospital, Fukuoka, Japan. 5. Department of Obstetrics and Gynecology, Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan. 6. Department of Obstetrics and Gynecology, Japan Community Health Care Organization Kyushu Hospital, Fukuoka, Japan. 7. Department of Obstetrics and Gynecology, Oita Prefectural Hospital, Oita, Japan. 8. Department of Obstetrics and Gynecology, Faculty of Medicine, Fukuoka University, Fukuoka, Japan. 9. Center for Maternal, Fetal, and Neonatal Medicine, Fukuoka University Hospital, Fukuoka, Japan; Department of Obstetrics and Gynecology, Faculty of Medicine, Fukuoka University, Fukuoka, 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. MATERIALS AND 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. CONCLUSION: 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.
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. MATERIALS AND 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. CONCLUSION: 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.