Postpartum ASA and NT-proBNP

Duke University114 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

114

Conditions

Blood Pressure

Interventions

Aspirin 81Mg Ec TabDRUG

Participant may be provided with a 6-week supply of 81 mg of aspirin prior to discharge from the delivery admission.

PlaceboDRUG

Participant may be provided with a 6-week supply of placebo to discharge from the delivery admission.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Duke University

Durham, North Carolina, United States

Outcomes

Primary Outcomes

NT-proBNP Levels at 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.