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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enoxaparin | Experimental | 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. |
|
| No treatment | No Intervention | Participants will receive no enoxaparin treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enoxaparin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | A pilot randomized controlled trial of low molecular weight heparin or no treatment following cesarean delivery NCT06118957 July 30, 2025 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Venous Thromboembolism | Objectively (by imaging) diagnosed deep vein thrombosis or pulmonary embolism | 6 Weeks |
| Rate of Wound Hematoma or Infection | Clinically diagnosed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann Bruno, MD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah | Salt Lake City | Utah | 84132 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: Enoxaparin | 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 |
| FG001 | No Intervention: No Treatment | Participants will receive no enoxaparin treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Rate of approach and enrollment of all screened eligible patients over the six-month study period by month
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| ID | Title | Description |
|---|---|---|
| BG000 | Enrolled | Participants who enrolled in the study |
| BG001 | Declined | Patients who declined participation in the study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Number | participants | A pilot randomized controlled trial of low molecular weight heparin or no treatment following cesarean delivery NCT06118957 July 30, 2025 6 weeks |
|
|
Within 6 Weeks Postpartum
Complications by study group
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enoxaparin | 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. Enoxaparin: 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood in Breast Milk | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Patient concern for blood in breast milk. Clinician examination negative and concern resolved. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Turner, MPH, Senior Regulatory Coordinator | University of Utah Obgyn | 8012018929 | elizabeth.e.turner@hsc.utah.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 3, 2024 | Aug 26, 2025 | Prot_SAP_ICF_002.pdf |
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| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
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| 6 Weeks |
| Rate of Bleeding Complications | Clinically diagnosed as readmission to hospital for bleeding or delayed postpartum hemorrhage (>24 hours after delivery) | 6 Weeks |
| BG002 | Total | Total of all reporting groups |
| years of age |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
|
| Secondary | Rate of Venous Thromboembolism | Objectively (by imaging) diagnosed deep vein thrombosis or pulmonary embolism | There were no reported incidents for venous thromboembolism | Posted | Number | # of venous thromboembolism events | 6 Weeks |
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|
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| Secondary | Rate of Wound Hematoma or Infection | Clinically diagnosed | Posted | Number | # of reported wound hematoma events | 6 Weeks |
|
|
|
| Secondary | Rate of Bleeding Complications | Clinically diagnosed as readmission to hospital for bleeding or delayed postpartum hemorrhage (>24 hours after delivery) | Posted | Number | # of reported bleeding complication even | 6 Weeks |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 4 |
| 32 |
| EG001 | No Treatment- | Participants will receive no enoxaparin treatment. | 0 | 32 | 0 | 32 | 3 | 32 |
|
| cholelithiasis | Gastrointestinal disorders | Systematic Assessment | Presentation to emergency department with right upper quadrant pain. Labs and ultrasound obtained consistent with cholelithiasis. Discharged with oral pain regimen. |
|
| Cellulitis | Infections and infestations | Systematic Assessment | Superficial surgical site infection with cellulitis, treated with oral antibiotics. |
|
| Uterine Rupture with broad ligament hematoma | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | uterine rupture with broad ligament expanding hematoma requiring return to surgery on post day # for evacuation of hemoperitoneum. Patient enrolled in trial but not yet received therapy or no therapy per randomization (at clinician discretion). |
|
| Surgical site infection | Infections and infestations | Systematic Assessment | Surgical site infection with abscess requiring intravenous antibiotics and incision drainage. |
|
| Superficial incision separation | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Superficial incision separation (2 mm by clinician examination). |
|
| Pancreatitis | Gastrointestinal disorders | Systematic Assessment | Presentation to emergency department with right upper quadrant pain. Labs and imaging obtained consistent with acute idiopathic pancreatitis without necrosis or infection. Conservatively managed. |
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| D002241 |
| Carbohydrates |