Postpartum ASA and NT-proBNP

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

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 Overview

• Status: Completed
• Conditions: Blood Pressure
• Intervention / Treatment: Drug: Aspirin 81Mg Ec Tab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment Group; 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; Participant may be provided with a 6-week supply of 81 mg of aspirin prior to discharge from the delivery admission.
Placebo Comparator: Placebo Group; 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; Participant may be provided with a 6-week supply of placebo to discharge from the delivery admission.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4-6 weeks postpartum

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Preeclampsia Diagnosis Postpartum	6 weeks postpartum
Number of Participants With Eclampsia	4-6 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 With Hospital Readmission for Bleeding-related Complications	4-6 weeks postpartum
Number of Participants Needing Blood Transfusion(s)	4-6 weeks postpartum

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Brenna Hughes, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): May 21, 2024
• Study Completion (Actual): May 21, 2024

Study Registration Dates

• First Submitted: May 25, 2023
• First Submitted That Met QC Criteria: May 25, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: May 20, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Fibrin Modulating Agents; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Antipyretics; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Fibrinolytic Agents; Platelet Aggregation Inhibitors; Aspirin
• Other Study ID Numbers: Pro00112143

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No