Ignite Creation Date:
2024-05-06 @ 7:44 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06118957
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2023-10-31
Brief Title:
Low Molecular Weight Heparin or no Treatment Following Cesarean Delivery
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
A Pilot Randomized Controlled Trial of Low Molecular Weight Heparin or no Treatment Following Cesarean Delivery
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None