Ignite Creation Date:
2024-07-17 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06468202
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-12
Brief Title:
Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy ASPIRIN TRIAL
Sponsor:
Ohio State University
Organization:
Ohio State University
Study Overview
Official Title:
Comparative Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy ASPIRIN TRIAL
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
ASPIRIN
Brief Summary:
The overall goal of this large pragmatic comparative effectiveness trial is to test the hypothesis that among at-risk individuals 162 mgday aspirin is superior to 81 mgday in preventing Hypertensive disorders of pregnancy HDP and that there are multiple factors associated with adherence with aspirin therapy that will be important to identify to enable optimal implementation of study findings and population-level benefits
Detailed Description:
Hypertensive disorders of pregnancy HDP such as preeclampsia PE and gestational hypertension gHTN occur in 15 of pregnant individuals disproportionately affect self-identified non-Hispanic Black individuals with the understanding that race is a socially defined construct and the inequity is related to social determinants of health are increasing in frequency and are associated with short- and long-term maternal and neonatal morbidities and mortality There are currently no available therapeutics to treat individuals with HDP thus developing interventions for the prevention of HDP is of substantial public health significance The US Preventive Services Task Force USPSTF and other professional societies recommend or endorse the use of aspirin for prevention of HDP in individuals at high or moderate risk However there is great uncertainty regarding optimal dosing whether there is heterogeneity of effectiveness of aspirin in reducing the risk of HDP among different populations and what factors are associated with adherence
The overall goal of this large pragmatic comparative effectiveness trial is to test the hypothesis that among at-risk individuals 162 mgday aspirin is superior to 81 mgday in preventing HDP and that there are multiple factors associated with adherence with aspirin therapy that will be important to identify to enable optimal implementation of study findings and population-level benefits The trial will achieve the following specific aims
Specific Aim 1 To compare the frequency of HDP primary outcome as well as other important secondary outcomes gHTN PE preterm PE PE-related adverse outcomes aspirin-related safety outcomes and patient-reported outcomes related to maternal health pregnancy and childbirth experiences between the two aspirin treatment arms
Specific Aim 2 To compare the gestational age at birth and the frequency of adverse perinatal outcomes preterm birth perinatal death small-for-gestational-age birth neonatal intensive care unit admission and complications of prematurity as well as patient-reported outcomes related to maternal-infant bonding between the two aspirin treatment arms
Specific Aim 3 To use quantitative and qualitative analyses to elucidate facilitators and barriers associated with adherence to aspirin therapy in at-risk individuals during pregnancy in order to facilitate future implementation
The overall goal of this large pragmatic comparative effectiveness trial is to test the hypothesis that among at-risk individuals 162 mgday aspirin is superior to 81 mgday in preventing HDP and that there are multiple factors associated with adherence with aspirin therapy that will be important to identify to enable optimal implementation of study findings and population-level benefits The trial will achieve the following specific aims
Specific Aim 1 To compare the frequency of HDP primary outcome as well as other important secondary outcomes gHTN PE preterm PE PE-related adverse outcomes aspirin-related safety outcomes and patient-reported outcomes related to maternal health pregnancy and childbirth experiences between the two aspirin treatment arms
Specific Aim 2 To compare the gestational age at birth and the frequency of adverse perinatal outcomes preterm birth perinatal death small-for-gestational-age birth neonatal intensive care unit admission and complications of prematurity as well as patient-reported outcomes related to maternal-infant bonding between the two aspirin treatment arms
Specific Aim 3 To use quantitative and qualitative analyses to elucidate facilitators and barriers associated with adherence to aspirin therapy in at-risk individuals during pregnancy in order to facilitate future implementation
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?:
False
Is an FDA AA801 Violation?:
None