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Anticoagulant
Impact of Prophylactic Low-molecular Weight Heparin Dosing on Clotting Parameters Following Cesarean Delivery
N/A
Waitlist Available
Led By Torri Metz, MD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up postoperative day #3 at peak (4-6 hours post-dose)
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare two ways of giving low molecular weight heparin to women after they have had a baby by C-section. One group will get a fixed dose and the other will get a dose based on their weight. The hypothesis is that more women in the weight-based group will reach the desired blood level.
Eligible Conditions
- Blood Clot
- Thromboembolic Disorders
- Deep vein thrombosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ postoperative day #3 at peak (4-6 hours post-dose)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~postoperative day #3 at peak (4-6 hours post-dose)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Prophylactic peak anti-Xa level
Secondary study objectives
Venous thromboembolism
Wound Complications
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Weight-based LMWHExperimental Treatment1 Intervention
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
Group II: Fixed LMWHActive Control1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enoxaparin
2017
Completed Phase 4
~32400
Find a Location
Who is running the clinical trial?
University of UtahLead Sponsor
1,147 Previous Clinical Trials
1,699,475 Total Patients Enrolled
Torri Metz, MDPrincipal InvestigatorUniversity of Utah
1 Previous Clinical Trials
25,604 Total Patients Enrolled