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

• Status: Recruiting
• Trial end date: 2023-03-15
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Utah
• Treatments: Calcium heparin; Dalteparin; Enoxaparin; Heparin; Heparin, Low-Molecular-Weight

Criteria

Inclusion Criteria:

• Cesarean delivery

• Meet facility guidelines for postpartum venous thromboembolism (VTE) prophylaxis:

Presence of 1 major, or 2 or more moderate, risk factors.

• Major risk factors: history of venous thromboembolism, high risk thrombophilia, BMI ≥40, high risk medical comorbidities (heart disease, sickle cell disease, systemic lupus erythematosus, inflammatory bowel disease), cesarean hysterectomy, nephrotic range proteinuria, or cesarean intrapartum/during labor

• Moderate risk factors: BMI > 30, multifetal pregnancy, postpartum hemorrhage (>1L blood loss), tobacco use, non-laboring or elective cesarean, preeclampsia, infection, preterm delivery (< 37 weeks gestational age), age > 35 years, low risk thrombophilia, family history of venous thromboembolism, stillbirth, varicose veins, prolonged labor (> 24 hours)

Exclusion Criteria:

• Contraindication to anticoagulation

• Plan for therapeutic anticoagulation (antepartum or postpartum)

• Known renal dysfunction (Creatinine clearance < 30 mL/minute)