Clincosm LogoSign in Get a demo

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

Sponsor
University of Utah (Other)
Overall Status
Completed
CT.gov ID
NCT04305756
Collaborator
(none)
146
Enrollment
1
Location
2
Arms
18.1
Actual Duration (Months)
8.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
146 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Impact of Prophylactic Low-molecular Weight Heparin Dosing on Clotting Parameters Following Cesarean Delivery
Actual Study Start Date :
Jun 12, 2020
Actual Primary Completion Date :
Dec 15, 2021
Actual Study Completion Date :
Dec 15, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Weight-based LMWH

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

Drug: Enoxaparin
Low molecular weight heparin
Other Names:
  • Lovenox

    		•
    Active Comparator: Fixed LMWH

    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

    Drug: Enoxaparin
    Low molecular weight heparin
    Other Names:
  • Lovenox

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Prophylactic peak anti-Xa level [Postoperative day #3 at peak (4-6 hours post-dose)]

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

    Secondary Outcome Measures

    1. Venous thromboembolism [From delivery through 6 weeks postpartum]

      Presence of venous thromboembolism as confirmed on diagnostic imaging

    2. Wound Complications [From delivery through 6 weeks postpartum]

      Post-cesarean wound hematoma

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Utah Salt Lake City Utah United States 84132

    Sponsors and Collaborators

    • University of Utah

    Investigators

    • Principal Investigator: Torri Metz, MD, University of Utah

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Torri Metz, Principal Investigator, University of Utah
    ClinicalTrials.gov Identifier:
    NCT04305756
    Other Study ID Numbers:
    • 130494
    First Posted:
    Mar 12, 2020
    Last Update Posted:
    Jan 28, 2022
    Last Verified:
    Jan 1, 2022
    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
    Keywords provided by Torri Metz, Principal Investigator, University of Utah
    Factor Xa
    Biomarkers
    Enoxaparin
    Additional relevant MeSH terms:
    Thrombosis
    Thromboembolism
    Enoxaparin

    Study Results

    No Results Posted as of Jan 28, 2022