Postpartum ASA and NT-proBNP

Study Overview
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Brief Summary
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This study is a double-blinded randomized-controlled trial in which patients will be randomized to 81 mg of aspirin or placebo to be continued for 6 weeks' postpartum. The purpose of this study is to compare NT-proBNP levels at the 4-6 week postpartum visit between groups. There is currently no data on the maternal health effects associated with continuation of low-dose aspirin in the postpartum period. This study aims to fill a gap in the knowledge regarding the utility of low-dose aspirin following delivery.

Official Title
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The Association Between Postpartum Aspirin Use and NT-proBNP Levels as a Marker for Maternal Health Outcomes.

Conditions
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Blood Pressure

Intervention / Treatment
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* Drug: Aspirin 81Mg Ec Tab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age and older English-speaking postpartum have met USPSTF recommendations for low-dose aspirin use during pregnancy: >1 high risk factor (history of preeclampsia in prior pregnancy, multifetal gestational, chronic hypertension, preexisting diabetes, renal disease, autoimmune disease) or >2 moderate risk factors (nulliparity, obesity, family history of preeclampsia, sociodemographic characteristics, age 35 years or older, or personal history factors) and reported at least 50% compliance with aspirin during pregnancy. Exclusion Criteria: hypersensitivity reaction to aspirin or other salicylates, history of gastrointestinal bleeding history of gastric or duodenal ulcers severe hepatic dysfunction bleeding disorders and diathesis known cardiac dysfunction with reduced ejection fraction, or are taking or prescribed ACE inhibitors. Patients who required ICU level care during their pregnancy will be excluded.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Treatment Arm vs Placebo Arm
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment Group<br>The treatment group will be provided with a 6-week supply of 81 mg of aspirin prior to discharge from the delivery admission. Patients will be scheduled for a 4-6 week postpartum clinic appointment, which is standard for these patients outside of this proposal. | Drug: Aspirin 81Mg Ec Tab<br>* Participant may be provided with a 6-week supply of 81 mg of aspirin prior to discharge from the delivery admission.<br>|
| Placebo Comparator: Placebo Group<br>The control group will receive a 6-week supply of placebo medication from the Investigational Pharmacy prior to discharge. The placebo will be identically appearing to the 81 mg aspirin. Patients will be scheduled for a 4-6 week postpartum clinic appointment, which is standard for these patients outside of this proposal. | Drug: Placebo<br>* Participant may be provided with a 6-week supply of placebo to discharge from the delivery admission.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NT-proBNP levels at 4 weeks postpartum | NT-proBNP levels at 4 weeks postpartum. Patients continued on 6 weeks of aspirin use postpartum and placebo. | 4 weeks postpartum | 
| NT-proBNP levels at 6 weeks postpartum | NT-proBNP levels at 6 weeks postpartum. Patients continued on 6 weeks of aspirin use postpartum and placebo. | 6 weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Blood Pressures | To compare average blood pressure readings at the 4-6 week postpartum visits. | 6 weeks postpartum | 
| Rate of preeclampsia diagnosis postpartum |  | 6 weeks postpartum | 
| Rate of eclampsia |  | 6 weeks postpartum | 
| Hospital readmission rates for blood pressure monitoring or cardiovascular disease work-up indications |  | 6 weeks postpartum | 
| Number of subjects requiring initiation or increase in blood pressure medications |  | 6 weeks postpartum | 
| hospital readmission rates for bleeding-related complications |  | 6 weeks postpartum | 
| Rate of blood transfusions |  | 6 weeks postpartum |