Safety and efficacy of thromboprophylaxis using enoxaparin sodium after cesarean section: A multi-center study in Japan.

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.