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

Primary Purpose

Thromboembolism, Postpartum DVT, Thrombosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enoxaparin
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Thromboembolism focused on measuring Factor Xa, Biomarkers, Enoxaparin

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Weight-based LMWH

Fixed LMWH

Arm Description

Participants will receive a weight-based dose of prophylactic enoxaparin. - For all BMI groups: 0.5mg/kg rounded to the nearest 10mg will be injected subcutaneously every 12 hours

Participants will receive a fixed dose of prophylactic enoxaparin. For BMI <40: 40mg injected subcutaneously every 24 hours For BMI > or = to 40: 40mg injected subcutaneously every 12 hours

Outcomes

Primary Outcome Measures

Prophylactic peak anti-Xa level
Anti-Xa level in prophylactic range (0.2 to 0.6 IU/mL)

Secondary Outcome Measures

Venous thromboembolism
Presence of venous thromboembolism as confirmed on diagnostic imaging
Wound Complications
Post-cesarean wound hematoma

Full Information

First Posted
March 9, 2020
Last Updated
January 26, 2022
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT04305756
Brief Title
Impact of Prophylactic Low-molecular Weight Heparin Dosing on Clotting Parameters Following Cesarean Delivery
Official Title
Impact of Prophylactic Low-molecular Weight Heparin Dosing on Clotting Parameters Following Cesarean Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
June 12, 2020 (Actual)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
December 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thromboembolism, Postpartum DVT, Thrombosis
Keywords
Factor Xa, Biomarkers, Enoxaparin

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Weight-based LMWH
Arm Type
Experimental
Arm Description
Participants will receive a weight-based dose of prophylactic enoxaparin. - For all BMI groups: 0.5mg/kg rounded to the nearest 10mg will be injected subcutaneously every 12 hours
Arm Title
Fixed LMWH
Arm Type
Active Comparator
Arm Description
Participants will receive a fixed dose of prophylactic enoxaparin. For BMI <40: 40mg injected subcutaneously every 24 hours For BMI > or = to 40: 40mg injected subcutaneously every 12 hours
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Other Intervention Name(s)
Lovenox
Intervention Description
Low molecular weight heparin
Primary Outcome Measure Information:
Title
Prophylactic peak anti-Xa level
Description
Anti-Xa level in prophylactic range (0.2 to 0.6 IU/mL)
Time Frame
Postoperative day #3 at peak (4-6 hours post-dose)
Secondary Outcome Measure Information:
Title
Venous thromboembolism
Description
Presence of venous thromboembolism as confirmed on diagnostic imaging
Time Frame
From delivery through 6 weeks postpartum
Title
Wound Complications
Description
Post-cesarean wound hematoma
Time Frame
From delivery through 6 weeks postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torri Metz, MD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
36075079
Citation
Bruno AM, Allshouse AA, Campbell HM, Branch DW, Lim MY, Silver RM, Metz TD. Weight-Based Compared With Fixed-Dose Enoxaparin Prophylaxis After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2022 Oct 1;140(4):575-583. doi: 10.1097/AOG.0000000000004937. Epub 2022 Sep 7.
Results Reference
derived

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

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