Postpartum ASA and NT-proBNP

Phase 4

Completed

Brief Summary: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Treatment Group	Aspirin 81Mg Ec Tab	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.
Placebo Group	Placebo	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.

Primary Outcome Measures

Name	Time	Method
NT-proBNP Levels at 4-6 Weeks Postpartum	4-6 weeks postpartum	The primary outcome for this analysis was NT-proBNP levels collected at the postpartum visit. Patients were reminded of this appointment the day prior to their scheduled follow-up visit. NT-proBNP levels were drawn at the 4-6 week postpartum visit. If patient did not present to their scheduled appointment, attempts were made to contact the patient and reschedule the visit and collect the lab sample for completion of the study.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Preeclampsia Diagnosis Postpartum	6 weeks postpartum
Number of Participants With Hospital Readmission for Blood Pressure Monitoring or Cardiovascular Disease Work-up Indications	6 weeks postpartum
Number of Participants Requiring Initiation or Increase in Blood Pressure Medications	4-6 weeks postpartum
Number of Participants Needing Blood Transfusion(s)	4-6 weeks postpartum
Number of Participants With Eclampsia	4-6 weeks postpartum
Number of Participants With Hospital Readmission for Bleeding-related Complications	4-6 weeks postpartum