NCT04305756

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Thromboembolism
• Postpartum DVT
• Thrombosis

Interventions

Type	Name	Description
DRUG	Enoxaparin	Low molecular weight heparin

Timeline

• Start date: 2020-06-12
• Primary completion: 2021-12-15
• Completion: 2021-12-15
• First posted: 2020-03-12
• Last updated: 2022-01-28

Locations

1 site across 1 country: United States