University of Utah
Salt Lake City, Utah, 84132, United States
NCT Number: NCT04305756
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.
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Notify Me18 year–55 year
Female
Interventional
Not applicable
Salt Lake City, Utah, 84132, United States
Venous thromboembolism (VTE) is a major contributor to maternal morbidity and mortality. The immediate postpartum period is a high risk time for VTE, and cesarean delivery is an additional risk factor. In the United States, use of postpartum VTE prophylaxis with low-molecular weight heparin (LMWH) is commonly used but without a standard protocol or dose across all hospitals. A fixed-dose of LMWH is frequently used based on data from non-obstetric studies. However, there are concerns that in the postpartum population this fixed dose may not be adequate for prophylaxis.
This study aims to evaluate the efficacy of fixed dose versus weight-based LMWH to reach prophylactic anti-Xa levels in post-cesarean delivery women. This will be a randomized controlled trial (RCT) with half of participants receiving a fixed dose of LMWH and half of participants receiving a weight-based dose of LMWH. The hypothesis is that the use of a weight-based LMWH compared to a fixed dose will result in more women achieving prophylactic anti-Xa levels.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Low molecular weight heparin
Other names: Lovenox
Time frame: Postoperative day #3 at peak (4-6 hours post-dose)
Anti-Xa level in prophylactic range (0.2 to 0.6 IU/mL)
Time frame: From delivery through 6 weeks postpartum
Presence of venous thromboembolism as confirmed on diagnostic imaging
Time frame: From delivery through 6 weeks postpartum
Post-cesarean wound hematoma
University of Utah
Other
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