drugset / Trial / NCT04305756

Impact of Prophylactic Low-molecular Weight Heparin Dosing on Clotting Parameters Following Cesarean Delivery

NCT04305756 ↗

Completed 146 enrolled University of Utah
RandomizedParallel-groupOpen-labelPrevention

Summary

The aim of this study is to evaluate the efficacy of two dosing regimens of low molecular weight heparin (LMWH) to reach prophylactic anti-factor Xa levels in post-cesarean delivery women. Half of participants will receive a fixed dose of LMWH, while the other half will receive a weight-based dose. The hypothesis is that the use of a weight-based dose will result in more women reaching prophylactic levels.

Timeline

Start
2020-06-12
Primary completion
2021-12-15
Completion
2021-12-15

Outcome

Met primary endpoint

paper Those who received weight-based dosing were more likely to achieve prophylactic anti-Xa levels than those who received fixed dosing in primary analysis PMID 36075079 ↗

paper 49/74 [66%] vs 32/72 [44%], relative risk [RR] 1.49, 95% CI 1.10-2.02 PMID 36075079 ↗

paper Weight-based dosing was more effective than fixed enoxaparin dosing in achieving prophylactic peak anti-Xa levels after cesarean delivery. PMID 36075079 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Enoxaparin sodium Other / unclassified 0.5 mg/kg Subcutaneous
Subject Enoxaparin sodium Other / unclassified 40 mg Subcutaneous