NCT04305756

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

June 12, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
Last Updated

January 28, 2022

Status Verified

January 1, 2022

Enrollment Period

1.5 years

First QC Date

March 9, 2020

Last Update Submit

January 26, 2022

Conditions

ThromboembolismPostpartum DVTThrombosis

Keywords

Factor XaBiomarkersEnoxaparin

Outcome Measures

Primary Outcomes (1)

  • Prophylactic peak anti-Xa level

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

    Postoperative day #3 at peak (4-6 hours post-dose)

Secondary Outcomes (2)

  • Venous thromboembolism

    From delivery through 6 weeks postpartum

  • Wound Complications

    From delivery through 6 weeks postpartum

Study Arms (2)

Weight-based LMWH

EXPERIMENTAL

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

Fixed LMWH

ACTIVE COMPARATOR

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

Interventions

EnoxaparinDRUG

Low molecular weight heparin

Also known as: Lovenox
Fixed LMWHWeight-based LMWH

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • Contraindication to anticoagulation
  • Plan for therapeutic anticoagulation (antepartum or postpartum)
  • Known renal dysfunction (Creatinine clearance \< 30 mL/minute)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (1)

  • 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.

    PMID: 36075079DERIVED

MeSH Terms

Conditions

ThromboembolismThrombosis

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Torri Metz, MD

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 9, 2020

First Posted

March 12, 2020

Study Start

June 12, 2020

Primary Completion

December 15, 2021

Study Completion

December 15, 2021

Last Updated

January 28, 2022

Record last verified: 2022-01

Locations

US(1)