M L Stephenson1,2, A E Serra1,2, J M Neeper1,2, D C Caballero2, J McNulty2. 1. Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of California Irvine Medical Center, Orange, CA, USA. 2. Department of Obstetrics and Gynecology, Memorial Care Center for Women at Miller Children's Hospital, Long Beach Memorial Medical Center, Long Beach, CA, USA.
Abstract
OBJECTIVE: To compare two enoxaparin dosing strategies at achieving prophylactic anti-Xa levels in women with a body mass index (BMI) ⩾35 (kg m(-2)) postcesarean delivery. STUDY DESIGN:Women with BMI ⩾35 were randomized to receive prophylactic enoxaparin at a fixed dose of 40 mg daily or weight-based dosing of 0.5 mg kg(-1) twice daily. The primary outcome was the proportion of subjects with peak anti-Xa levels in the prophylactic range of 0.2 to 0.6 IU ml(-1). RESULT: From August 2013 through February 2014, 84 demographically similar women completed the protocol. In the weight-based group, 88% (37/42) of the women reached prophylactic anti-Xa levels versus 14% (6/42) in the fixed dose group (odds ratio 44.4, 95% confidence interval 12.44, 158.48, P<0.001). No anti-Xa level exceeded 0.48 IU ml(-1). There were no venous thromboembolic or bleeding events requiring reoperation or transfusion in either group. CONCLUSION: Compared with fixed dosing daily, weight-based dosing twice daily more effectively achieved prophylactic anti-Xa levels without reaching the therapeutic range.
RCT Entities:
OBJECTIVE: To compare two enoxaparin dosing strategies at achieving prophylactic anti-Xa levels in women with a body mass index (BMI) ⩾35 (kg m(-2)) postcesarean delivery. STUDY DESIGN:Women with BMI ⩾35 were randomized to receive prophylactic enoxaparin at a fixed dose of 40 mg daily or weight-based dosing of 0.5 mg kg(-1) twice daily. The primary outcome was the proportion of subjects with peak anti-Xa levels in the prophylactic range of 0.2 to 0.6 IU ml(-1). RESULT: From August 2013 through February 2014, 84 demographically similar women completed the protocol. In the weight-based group, 88% (37/42) of the women reached prophylactic anti-Xa levels versus 14% (6/42) in the fixed dose group (odds ratio 44.4, 95% confidence interval 12.44, 158.48, P<0.001). No anti-Xa level exceeded 0.48 IU ml(-1). There were no venous thromboembolic or bleeding events requiring reoperation or transfusion in either group. CONCLUSION: Compared with fixed dosing daily, weight-based dosing twice daily more effectively achieved prophylactic anti-Xa levels without reaching the therapeutic range.
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