A randomized controlled trial of differing doses of postcesarean enoxaparin thromboprophylaxis in obese women

M L Stephenson; A E Serra; J M Neeper; D C Caballero; J McNulty

doi:10.1038/jp.2015.130

A randomized controlled trial of differing doses of postcesarean enoxaparin thromboprophylaxis in obese women

J Perinatol. 2016 Feb;36(2):95-9. doi: 10.1038/jp.2015.130. Epub 2015 Dec 10.

Authors

M L Stephenson^{1

2}, A E Serra^{1

2}, J M Neeper^{1

2}, D C Caballero², J McNulty²

Affiliations

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.

PMID: 26658126
DOI: 10.1038/jp.2015.130

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.

Trial registration: ClinicalTrials.gov NCT02070237.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Blood Coagulation / drug effects*
Body Mass Index
Chemoprevention / methods
Dose-Response Relationship, Drug
Drug Administration Schedule
Drug Monitoring
Enoxaparin* / administration & dosage
Enoxaparin* / adverse effects
Factor Xa
Factor Xa Inhibitors / administration & dosage
Factor Xa Inhibitors / adverse effects
Female
Hemorrhage / chemically induced
Hemorrhage / prevention & control
Humans
Obesity* / complications
Obesity* / diagnosis
Pregnancy
Pregnancy Complications / diagnosis*
Thromboembolism / etiology
Thromboembolism / prevention & control*
Treatment Outcome

Substances

Enoxaparin
Factor Xa Inhibitors
Factor Xa

Associated data

ClinicalTrials.gov/NCT02070237