Thromboembolism
Conditions
Keywords
Thromboembolism, Enoxaparin, Cesarean delivery
Brief summary
The aim of this study is to evaluate the feasibility of randomizing individuals to low molecular weight heparin (enoxaparin) or no treatment following cesarean delivery. The investigators hypothesize that among eligible individuals, at least 35% will enroll, undergo randomization, and complete the allocated treatment group.
Detailed description
Venous thromboembolism (VTE) is a major contributor to maternal morbidity and mortality. The first two weeks postpartum are the highest risk period for VTE during pregnancy and the postpartum period. Cesarean delivery is a known risk factor for VTE. In the United States, postpartum prophylaxis with low molecular weight heparin (e.g., enoxaparin) is commonly used during the first 10-14 days after delivery. Enoxaparin has not been demonstrated as an effective intervention to prevent postpartum VTE after cesarean delivery. Before larger scale studies may be completed, a better understanding of ability to randomize individuals to this intervention is needed. This study aims to evaluate the feasibility of randomizing individuals after cesarean delivery to the receipt of enoxaparin prophylaxis or no treatment.
Interventions
DRUGEnoxaparin
Participants will receive weight-based dosing of enoxaparin at 0.5 mg/kg rounded to the nearest 10 mg every 12 hours based on delivery admission weight. Participants will receive therapy for 14 days.
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Cesarean delivery at the University of Utah Health
Exclusion criteria
* Contraindication to anticoagulation * Plan for therapeutic anticoagulation * Known renal dysfunction (creatinine clearance \<30mL/minute) * History of venous thromboembolism * High risk thrombophilia * Receipt of antepartum anticoagulation for \>2 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Eligible Individuals Enrolled and Retained Through Full Study Procedures | A pilot randomized controlled trial of low molecular weight heparin or no treatment following cesarean delivery NCT06118957 July 30, 2025 6 weeks | Feasibility as defined by ≥35% enrollment of eligible individuals and retention ≥85% of enrolled individuals through all study procedures |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Venous Thromboembolism | 6 Weeks | Objectively (by imaging) diagnosed deep vein thrombosis or pulmonary embolism |
| Rate of Wound Hematoma or Infection | 6 Weeks | Clinically diagnosed |
| Rate of Bleeding Complications | 6 Weeks | Clinically diagnosed as readmission to hospital for bleeding or delayed postpartum hemorrhage (\>24 hours after delivery) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Enrolled Participants who enrolled in the study | 64 |
| Declined Patients who declined participation in the study | 547 |
| Total | 611 |
Baseline characteristics
| Characteristic | Declined | Total | Enrolled |
|---|---|---|---|
| Age, Continuous | 31.37 years of age STANDARD_DEVIATION 5.7 | 31.32 years of age STANDARD_DEVIATION 5.66 | 30.95 years of age STANDARD_DEVIATION 5.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 156 Participants | 170 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 315 Participants | 355 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 76 Participants | 86 Participants | 10 Participants |
| Sex: Female, Male Female | 547 Participants | 611 Participants | 64 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 32 |
| other Total, other adverse events | 4 / 32 | 3 / 32 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 |
Outcome results
Primary
Rate of Eligible Individuals Enrolled and Retained Through Full Study Procedures
Feasibility as defined by ≥35% enrollment of eligible individuals and retention ≥85% of enrolled individuals through all study procedures
Time frame: A pilot randomized controlled trial of low molecular weight heparin or no treatment following cesarean delivery NCT06118957 July 30, 2025 6 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eligible Participants | Rate of Eligible Individuals Enrolled and Retained Through Full Study Procedures | # of eligible patients | 694 participants |
| Eligible Participants | Rate of Eligible Individuals Enrolled and Retained Through Full Study Procedures | Approach rate (proportion of eligible patients approached) | 611 participants |
| Eligible Participants | Rate of Eligible Individuals Enrolled and Retained Through Full Study Procedures | Enrollment rate (proportion of eligible patients enrolled) | 64 participants |
| Eligible Participants | Rate of Eligible Individuals Enrolled and Retained Through Full Study Procedures | Retention rate (proportion enrolled completing study) | 61 participants |
Secondary
Rate of Bleeding Complications
Clinically diagnosed as readmission to hospital for bleeding or delayed postpartum hemorrhage (\>24 hours after delivery)
Time frame: 6 Weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eligible Participants | Rate of Bleeding Complications | 0 # of reported bleeding complication even |
| No Treatment | Rate of Bleeding Complications | 1 # of reported bleeding complication even |
Secondary
Rate of Venous Thromboembolism
Objectively (by imaging) diagnosed deep vein thrombosis or pulmonary embolism
Time frame: 6 Weeks
Population: There were no reported incidents for venous thromboembolism
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eligible Participants | Rate of Venous Thromboembolism | 0 # of venous thromboembolism events |
| No Treatment | Rate of Venous Thromboembolism | 0 # of venous thromboembolism events |
Secondary
Rate of Wound Hematoma or Infection
Clinically diagnosed
Time frame: 6 Weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eligible Participants | Rate of Wound Hematoma or Infection | 2 # of reported wound hematoma events |
| No Treatment | Rate of Wound Hematoma or Infection | 1 # of reported wound hematoma events |