Low Molecular Weight Heparin or no Treatment Following Cesarean Delivery

Utah System of Higher Education (USHE)

Status and phase: Completed; Phase 2

Conditions: Thromboembolism

Treatments: Drug: Enoxaparin

Study type: Interventional

Funder types: Other

Identifiers

NCT06118957

IRB_00167480

Details and patient eligibility

About

The aim of this study is to evaluate the feasibility of randomizing individuals to low molecular weight heparin (enoxaparin) or no treatment following cesarean delivery. The investigators hypothesize that among eligible individuals, at least 35% will enroll, undergo randomization, and complete the allocated treatment group.

Full description

Venous thromboembolism (VTE) is a major contributor to maternal morbidity and mortality. The first two weeks postpartum are the highest risk period for VTE during pregnancy and the postpartum period. Cesarean delivery is a known risk factor for VTE. In the United States, postpartum prophylaxis with low molecular weight heparin (e.g., enoxaparin) is commonly used during the first 10-14 days after delivery. Enoxaparin has not been demonstrated as an effective intervention to prevent postpartum VTE after cesarean delivery. Before larger scale studies may be completed, a better understanding of ability to randomize individuals to this intervention is needed. This study aims to evaluate the feasibility of randomizing individuals after cesarean delivery to the receipt of enoxaparin prophylaxis or no treatment.

Enrollment: 64 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Cesarean delivery at the University of Utah Health

Exclusion criteria

• Contraindication to anticoagulation
• Plan for therapeutic anticoagulation
• Known renal dysfunction (creatinine clearance <30mL/minute)
• History of venous thromboembolism
• High risk thrombophilia
• Receipt of antepartum anticoagulation for >2 weeks

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Enoxaparin

Experimental group

Description:

Participants will receive weight-based dosing of enoxaparin at 0.5 mg/kg rounded to the nearest 10 mg every 12 hours based on delivery admission weight. Participants will receive therapy for 14 days.

Treatment:

Drug: Enoxaparin

No treatment

No Intervention group

Description:

Participants will receive no enoxaparin treatment.