Impact of Prophylactic Low-molecular Weight Heparin Dosing on Clotting Parameters Following Cesarean Delivery
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Postpartum DVT
- Thromboembolism
- Thrombosis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 55 years
- Gender
- Only males
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) i...
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.
Tracking Information
- NCT #
- NCT04305756
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Torri Metz, MD University of Utah