Status:
COMPLETED
Impact of Prophylactic Low-molecular Weight Heparin Dosing on Clotting Parameters Following Cesarean Delivery
Lead Sponsor:
University of Utah
Conditions:
Thromboembolism
Postpartum DVT
Eligibility:
FEMALE
18-55 years
Phase:
NA
Brief 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 par...
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...
Eligibility Criteria
Inclusion
- 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
- Contraindication to anticoagulation
- Plan for therapeutic anticoagulation (antepartum or postpartum)
- Known renal dysfunction (Creatinine clearance \< 30 mL/minute)
Key Trial Info
Start Date :
June 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2021
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT04305756
Start Date
June 12 2020
End Date
December 15 2021
Last Update
January 28 2022
Active Locations (1)
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1
University of Utah
Salt Lake City, Utah, United States, 84132