Clinical trial NCT04305756: 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
Overall status: COMPLETED
Phase: NA
Conditions: Thromboembolism
Postpartum DVT
Thrombosis
Keywords: Factor Xa
Biomarkers
Enoxaparin
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2020-03-12
Enrollment: 146
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Prophylactic peak anti-Xa level
timeFrame: Postoperative day #3 at peak (4-6 hours post-dose)
Secondary outcomes:
measure: Venous thromboembolism
timeFrame: From delivery through 6 weeks postpartum
measure: Wound Complications
timeFrame: From delivery through 6 weeks postpartum
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Torri Metz, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.