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Completed

NCT Number: NCT04305756

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah

Salt Lake City, Utah, 84132, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Enoxaparin

Drug

Low molecular weight heparin

Other names: Lovenox

Primary outcomes

  1. Prophylactic peak anti-Xa level

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

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

Secondary outcomes

  1. Venous thromboembolism

    Time frame: From delivery through 6 weeks postpartum

    Presence of venous thromboembolism as confirmed on diagnostic imaging

  2. Wound Complications

    Time frame: From delivery through 6 weeks postpartum

    Post-cesarean wound hematoma

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 12, 2020
Registry last updated
Jan 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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